SecProbe.io

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 Windtree Therapeutics Inc.

 2600 Kelly Road, Suite 100

 Warrington, Pennsylvania 18976

 July 10, 2025

 VIA EDGAR

 Securities and Exchange Commission

 Division of Corporation Finance

 Office of Life Sciences

 100 F Street, N.E.

 Washington, D.C. 20549-3561

 Re:

 Windtree Therapeutics Inc.

 Registration Statement on Form S-1 (the “ Registration Statement ” )

 Filed July 10, 2025

 File No. 333-287358

 Ladies and Gentlemen:

 Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, Windtree Therapeutics Inc. (the “ Company ”) hereby requests acceleration of the effectiveness date of the above referenced Registration Statement, so that it will become effective at 9:30 a.m., Eastern Time, on July 11, 2025, or as soon thereafter as practicable, or at such other time as the Company or its outside counsel, Thompson Hine LLP, request by telephone that such Registration Statement be declared effective.

 Please contact Faith L. Charles of Thompson Hine LLP, outside counsel to the Company, at (212) 908-3905, as soon as the Registration Statement has been declared effective, or if you have any other questions or concerns regarding this matter.

 Sincerely,

 WINDTREE THERAPEUTICS INC.

 /s/ Jed Latkin

 Jed Latkin

 Chief Executive Officer

 cc:

 Faith L. Charles (Thompson Hine LLP)

<DOCUMENT>
<TYPE>TEXT-EXTRACT
<SEQUENCE>2
<FILENAME>filename2.txt
<TEXT>
 May 21, 2025

Jed Latkin
President and Chief Executive Officer
Windtree Therapeutics, Inc.
2600 Kelly Road, Suite 100
Warrington, Pennsylvania 18976

 Re: Windtree Therapeutics, Inc.
 Registration Statement on Form S-1
 Filed May 16, 2025
 File No. 333-287358
Dear Jed Latkin:

 This is to advise you that we have not reviewed and will not review your
registration
statement.

 Please refer to Rules 460 and 461 regarding requests for acceleration.
We remind you
that the company and its management are responsible for the accuracy and
adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action
by the staff.

 Please contact Tim Buchmiller at 202-551-3635 with any questions.

 Sincerely,

 Division of
Corporation Finance
 Office of Life
Sciences
cc: Faith L. Charles, Esq.
</TEXT>
</DOCUMENT>

CORRESP
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 wint20250424_corresp.htm

 Windtree Therapeutics, Inc.

 2600 Kelly Road, Suite 100

 Warrington, Pennsylvania 18976

 April 24, 2024

 VIA EDGAR

 U.S. Securities and Exchange Commission

 Division of Corporation Finance

 Office of Life Sciences

 100 F Street, NE

 Washington, D.C. 20549

 Re:

 Windtree Therapeutics, Inc.

 Registration Statement on Form S-1

 SEC File No. 333-284976

 Request for Acceleration

 To whom it may concern:

 Pursuant to Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933, as amended, Windtree Therapeutics, Inc. (the “ Company ”) hereby requests that the effective date of the Company’s Registration Statement on Form S-1 (File No. 333-284976) (the “ Registration Statement ”) be accelerated so that the Company’s Registration Statement will become effective at 9:00 A.M., eastern time, on April 25, 2025, or as soon thereafter as is practicable, or at such other time thereafter as our counsel, Thompson Hine LLP, may request by telephone. Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Thompson Hine LLP, by calling Faith L. Charles at (212) 908-3905.

 Please feel free to direct any questions or comments concerning this request to Faith L. Charles of Thompson Hine LLP at (212) 908-3905.

 WINDTREE THERAPEUTICS, INC.

 By:

 /s/ Jed Latkin

 Name: Jed Latkin

 Title: President and Chief Executive Officer

 Cc: Faith L. Charles, Thompson Hine LLP

February 19, 2025
Jed Latkin
President and Chief Executive Officer
Windtree Therapeutics, Inc.
2600 Kelly Road, Suite 100
Warrington, PA 18976
Re:Windtree Therapeutics, Inc.
Registration Statement on Form S-1
Filed February 14, 2025
File No. 333-284976
Dear Jed Latkin:
            This is to advise you that we have not reviewed and will not review your registration
statement.
            Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
            Please contact Jason Drory at 202-551-8342 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Faith L. Charles

August 28, 2024
Craig E. Fraser
President and Chief Executive Officer
Windtree Therapeutics, Inc.
2600 Kelly Road, Suite 100
Warrington, PA 18976
Re:Windtree Therapeutics, Inc.
Registration Statement on Form S-3
Filed August 21, 2024
File No. 333-281688
Dear Craig E. Fraser:
            This is to advise you that we have not reviewed and will not review your registration
statement.
            Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that
the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
            Please contact Daniel Crawford at 202-551-7767 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Jennifer Porter, Esq.

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Windtree Therapeutics, Inc.

2600 Kelly Road, Suite 100

Warrington, Pennsylvania 18976

August 28, 2024

VIA EDGAR

U.S. Securities and Exchange Commission

Division of Corporation Finance

Office of Life Sciences

100 F Street, NE

Washington, D.C. 20549

Attn: Daniel Crawford

			Re:

			Windtree Therapeutics, Inc.

Registration Statement on Form S-1

SEC File No. 333-281755

Request for Acceleration

Mr. Crawford:

Pursuant to Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933, as amended, Windtree Therapeutics, Inc. (the “Company”) hereby requests that the effective date of the Company’s Registration Statement on Form S-1 (File No. 333-281755) (the “Registration Statement”) be accelerated so that the Company’s Registration Statement will become effective at 8:00 A.M., eastern time, on September 3, 2024, or as soon thereafter as is practicable, or at such other time thereafter as our counsel, Goodwin Procter LLP, may request by telephone. Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Goodwin Procter LLP, by calling Justin Platt at (212) 459-7340.

Please feel free to direct any questions or comments concerning this request to Justin Platt, Esq. of Goodwin Procter LLP at (212) 459-7340.

			WINDTREE THERAPEUTICS, INC.

			By:

			/s/ Craig E. Fraser

			Name: Craig E. Fraser

			Title: President and Chief Executive Officer

Cc: Justin Platt, Esq., Goodwin Procter LLP

CORRESP
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	wint20240828c_corresp.htm

Windtree Therapeutics, Inc.

2600 Kelly Road, Suite 100

Warrington, Pennsylvania 18976

August 28, 2024

VIA EDGAR

U.S. Securities and Exchange Commission

Division of Corporation Finance

Office of Life Sciences

100 F Street, NE

Washington, D.C. 20549

Attn: Daniel Crawford

			Re:

			Windtree Therapeutics, Inc.

Registration Statement on Form S-3

SEC File No. 333-281688

Request for Acceleration

Mr. Crawford:

Pursuant to Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933, as amended, Windtree Therapeutics, Inc. (the “Company”) hereby requests that the effective date of the Company’s Registration Statement on Form S-3 (File No. 333-281688) (the “Registration Statement”) be accelerated so that the Company’s Registration Statement will become effective at 8:00 A.M., eastern time, on September 3, 2024, or as soon thereafter as is practicable, or at such other time thereafter as our counsel, Goodwin Procter LLP, may request by telephone. Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Goodwin Procter LLP, by calling Justin Platt at (212) 459-7340.

Please feel free to direct any questions or comments concerning this request to Justin Platt, Esq. of Goodwin Procter LLP at (212) 459-7340.

			WINDTREE THERAPEUTICS, INC.

			By:

			/s/ Craig E. Fraser

			Name: Craig E. Fraser

			Title: President and Chief Executive Officer

Cc: Justin Platt, Esq., Goodwin Procter LLP

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Windtree Therapeutics, Inc.

2600 Kelly Road, Suite 100

Warrington, Pennsylvania 18976

April 17, 2024

VIA EDGAR

U.S. Securities and Exchange Commission

Division of Corporation Finance

Office of Life Sciences

100 F Street, NE

Washington, D.C. 20549

Attn: Doris Stacey Gama

			Re:

			Windtree Therapeutics, Inc.

			Registration Statement on Form S-3

			SEC File No. 333-277073

			Request for Acceleration

Ms. Gama:

Pursuant to Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933, as amended, Windtree Therapeutics, Inc. (the “Company”) hereby requests that the effective date of the Company’s Registration Statement on Form S-3 (File No. 333-277073) (the “Registration Statement”) be accelerated so that the Company’s Registration Statement will become effective at 4:00 P.M., eastern time, on April 19, 2024, or as soon thereafter as is practicable, or at such other time thereafter as our counsel, Goodwin Procter LLP, may request by telephone. Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Goodwin Procter LLP, by calling Justin Platt at (212) 459-7340.

Please feel free to direct any questions or comments concerning this request to Justin Platt, Esq. of Goodwin Procter LLP at (212) 459-7340.

			WINDTREE THERAPEUTICS, INC.

			By:

			/s/ Craig E. Fraser

			Name: Craig E. Fraser

			Title: President and Chief Executive Officer

Cc: Justin Platt, Esq., Goodwin Procter LLP

United States securities and exchange commission logo
February 20, 2024
Craig Fraser
Chief Executive Officer
Wintertree Therapeutics, Inc.
2600 Kelly Road, Suite 100
Warrington, PA 18976
Re:Wintertree Therapeutics, Inc.
Registration Statement on Form S-3
Filed February 14, 2024
File No. 333-277073
Dear Craig Fraser:
            This is to advise you that we have not reviewed and will not review your registration
statement.
            Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
            Please contact Doris Stacey Gama at 202-551-3188 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Justin Platt, Esq.

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Windtree Therapeutics, Inc.

2600 Kelly Road, Suite 100

Warrington, Pennsylvania 18976

May 25, 2023

VIA EDGAR

U.S. Securities and Exchange Commission

Division of Corporation Finance

Office of Life Sciences

100 F Street, NE

Washington, D.C. 20549

Attn: Jimmy McNamara

			Re:

			Windtree Therapeutics, Inc.

			Registration Statement on Form S-3

			SEC File No. 333-272095

			Request for Acceleration

Mr. McNamara:

Pursuant to Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933, as amended, Windtree Therapeutics, Inc. (the “Company”) hereby requests that the effective date of the Company’s Registration Statement on Form S-3 (File No. 333-272095) (the “Registration Statement”) be accelerated so that the Company’s Registration Statement will become effective at 4:00 P.M., eastern time, on May 30, 2023, or as soon thereafter as is practicable, or at such other time thereafter as our counsel, Goodwin Procter LLP, may request by telephone. Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Goodwin Procter LLP, by calling Jennifer Porter at (445) 207-7806.

Please feel free to direct any questions or comments concerning this request to Jennifer Porter, Esq. of Goodwin Procter LLP at (445) 207-7806.

			WINDTREE THERAPEUTICS, INC.

			By:

			/s/ Craig E. Fraser

			Name: Craig E. Fraser

			Title: President and Chief Executive Officer

Cc: Jennifer Porter, Goodwin Procter LLP

United States securities and exchange commission logo
May 24, 2023
Craig Fraser
President and Chief Executive Officer
Windtree Therapeutics, Inc.
2600 Kelly Road, Suite 100
Warrington, Pennsylvania 18976
Re:Windtree Therapeutics, Inc.
Registration Statement on Form S-3
Filed May 19, 2023
File No. 333-272095
Dear Craig Fraser:
            This is to advise you that we have not reviewed and will not review your registration
statement.
            Please refer to Rules 460 and 461 regarding requests for acceleration.  We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
            Please contact Jimmy McNamara at 202-551-7349 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Jennifer Porter, Esq.

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Windtree Therapeutics, Inc.

2600 Kelly Road, Suite 100

Warrington, Pennsylvania 18976

April 17, 2023

VIA EDGAR

U.S. Securities and Exchange Commission

Division of Corporation Finance

Office of Life Sciences

100 F Street, NE

Washington, D.C. 20549

Attn: Lauren Hamill

			Re:

			Windtree Therapeutics, Inc.

Registration Statement on Form S-1

SEC File No. 333-269775

Request for Acceleration

Ms. Hamill:

Pursuant to Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933, as amended, Windtree Therapeutics, Inc. (the “Company”) hereby requests that the effective date of the Company’s Registration Statement on Form S-1 (File No. 333-269775), as amended (the “Registration Statement”) be accelerated so that the Company’s Registration Statement will become effective at 8:00 A.M., eastern time, on April 19, 2023, or as soon thereafter as is practicable, or at such other time thereafter as our counsel, Goodwin Procter LLP, may request by telephone. Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Goodwin Procter LLP, by calling Jennifer Porter at (445) 207-7806.

Please feel free to direct any questions or comments concerning this request to Jennifer Porter, Esq. of Goodwin Procter LLP at (445) 207-7806.

			WINDTREE THERAPEUTICS, INC.

			By:

			/s/ Craig E. Fraser

			Name: Craig E. Fraser

			Title: President and Chief Executive Officer

Cc: Jennifer Porter, Goodwin Procter LLP

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Ladenburg Thalmann & Co. Inc.

640 Fifth Avenue, 4th Floor

New York, New York 10019

April 17, 2023

VIA FACSIMILE AND EDGAR

U.S. Securities and Exchange Commission

Division of Corporation Finance

Washington, DC 20549

			Re:

			Windtree Therapeutics, Inc.

			Registration Statement on Form S-1 (Registration No. 333-269775)

			Concurrence in Acceleration Request

Ladies and Gentlemen:

Ladenburg Thalmann & Co. Inc. (“Ladenburg”), as representative of the underwriters for the referenced offering, hereby concurs in the request by Windtree Therapeutics, Inc. that the effective date of the above-referenced registration statement be accelerated to 8:00 a.m. (Eastern Time), or as soon as practicable thereafter, on April 19, 2023, pursuant to Rule 461 under the Securities Act. Ladenburg affirms that it is aware of its obligations under the Securities Act in connection with this offering.

			Very truly yours,

			LADENBURG THALMANN & CO. INC.

			By:

			/s/ Nicholas Stergis

			Name: Nicholas Stergis

			Title: Managing Director

United States securities and exchange commission logo
February 21, 2023
Craig Fraser
Chief Executive Officer
WINDTREE THERAPEUTICS INC /DE/
2600 Kelly Road, Suite 100
Warrington, PA 18976
Re:WINDTREE THERAPEUTICS INC /DE/
Registration Statement on Form S-1
Filed February 14, 2023
File No. 333-269775
Dear Craig Fraser:
            This is to advise you that we have not reviewed and will not review your registration
statement.
            Please refer to Rules 460 and 461 regarding requests for acceleration.  We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
            Please contact Lauren Hamill at 303-844-1008 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Jennifer Porter

United States securities and exchange commission logo
January 12, 2023
John Hamill
Chief Financial Officer
WINDTREE THERAPEUTICS INC /DE/
2600 Kelly Road, Suite 100
Warrington, PA 18976
Re:WINDTREE THERAPEUTICS INC /DE/
Preliminary Proxy Statement on Schedule 14A
Filed November 22, 2022, as amended
File No. 001-39290
Dear John Hamill:
            We have completed our review of your filing.  We remind you that the company and its
management are responsible for the accuracy and adequacy of their disclosures, notwithstanding
any review, comments, action or absence of action by the staff.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Jennifer Porter

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			Troutman Pepper Hamilton Sanders LLP

			3000 Two Logan Square, Eighteenth and Arch Streets

			Philadelphia, PA 19103-2799

			troutman.com

			January 6, 2023

VIA EDGAR

U.S. Securities and Exchange Commission

100 F. Street, N.E.

Washington, D.C. 20549

Attention: Lauren Hamill and Laura Crotty

			Re:

			Windtree Therapeutics, Inc.

			Amended Preliminary Proxy Statement on Schedule 14A

			Filed December 23, 2022

			File No. 001-39290

Ladies and Gentlemen:

We are submitting this letter on behalf of our client Windtree Therapeutics, Inc. (the “Company”), in response to the written comments of the staff (the “Staff”) of the U.S. Securities and Exchange Commission (the “SEC”) contained in your letter, dated January 5, 2023 (the “Comment Letter”) in connection with the Company’s Amended Preliminary Proxy Statement on Schedule 14A (the “PRER14A”), filed on December 23, 2022. In response to the comments set forth in the Comment Letter the Company has revised the PRER14A and is filing a revised draft (the “Amended PRER14A”) with this response letter.

For your convenience, our responses are set forth below, with the headings and numbered items of this letter corresponding to the headings and numbered items contained in the Comment Letter. Each of the comments from the Comment Letter is restated in bold and italics prior to the Company’s response. Capitalized terms used but not defined in this letter shall have the respective meanings given to such terms in the Amended PRER14A.

Amended Preliminary Proxy Statement on Schedule 14A filed December 23, 2022

General

			1.

			Please revise your disclosure to clearly state that the mirrored voting function of the Series A Preferred Stock will have a significant impact on the vote needed to pass Proposal 1 relating to the reverse stock split. In this regard, assuming the minimum quorum is met with no additional shares of common stock appearing in person or by proxy, it appears the mirrored voting mechanism of the Series A Preferred Stock will result in the company only needing 16.667% (1/6) of the common shares outstanding to vote in favor of Proposal 1 rather than a vote in favor of at least 50.001%. Please clearly disclose these figures, expressed as percentages, so shareholders may understand the impact the Series A Preferred Stock will have on the ability of the company to pass Proposal 1.

			Securities and Exchange Commission

			January 6, 2023

			Page 2

The Company respectfully advises the Staff that it has revised its disclosure by adding the following paragraph on page 8 of the Amended PRER14A as follows:

“The mirrored voting function of our Series A Preferred Stock will have a significant impact on the on number of votes required to approve the Reverse Stock Split Proposal. Assuming the minimum quorum requirement of holders representing one-third (1/3) of the votes stockholders are entitled to cast at the Special Meeting (including at least one-third (1/3) of the votes represented by our Common Stock) is met, and no other holders of shares of our Common Stock are present, virtually in person or by proxy at the Special Meeting, the Reverse Stock Split Proposal could be approved by holders representing only 16.667% of our outstanding Common Stock (along with their Series A Preferred Stock) voting to approve the Reverse Stock Split Proposal, rather than at least 50.001% of our outstanding Common Stock, which would be required absent the existence of the Series A Preferred Stock.”

			2.

			We note the following statement included in your response to our prior comment 5: "whether the approval of an amendment to the Amended and Restated Certificate of Incorporation such as the one contemplated in the Preliminary Proxy Statement through a vote which includes the vote of a super-voting preferred stock alters or changes the powers, preferences, or special rights of the Common Stock so as to affect them adversely (as set forth in Section 242(b) of the Delaware General Corporation Law (the “DGCL”)) has not been determined by a Delaware court to date and is not specifically provided for in the applicable statutes." Please include the substance of this statement in the proxy statement itself and discuss the surrounding uncertainty of using this approach in an attempt to pass Proposal 1.

The Company respectfully advises the Staff that it has revised its disclosure by adding the following paragraph on page 5 and 14 of the Amended PRER14A as follows:

“There is uncertainty as to whether Delaware courts would find the use of our Series A Preferred Stock to approve the Reverse Stock Split Proposal would be sufficient under Delaware Law - The use of super-voting preferred stock, such as the Series A Preferred Stock, to approve an amendment to a company’s certificate of incorporation has not been validated by a Delaware court to date and has been neither specifically prohibited by, nor provided for, in applicable statutes. There can be no assurance that a Delaware court would not find that the use of our Series A Preferred Stock to approve the Reverse Stock Split Proposal does not alter or change the powers, preferences, or special rights of our Common Stock, or is not otherwise determined to be an insufficient method for approving the Reverse Stock Split Proposal.”

We thank you for your prompt attention to this letter responding to the Staff’s Comment Letter and look forward to hearing from you at your earliest convenience. Please direct any questions concerning this filing to the undersigned at 215.981.4339.

			Sincerely,

			/s/ Jennifer L. Porter, Esq.

			     Jennifer L. Porter, Esq.

			cc:

			Via Email

			John Hamill, Windtree Therapeutics, Inc.

			Rachael M. Bushey, Troutman Pepper Hamilton Sanders LLP

United States securities and exchange commission logo
January 5, 2023
John Hamill
Chief Financial Officer
WINDTREE THERAPEUTICS INC /DE/
2600 Kelly Road, Suite 100
Warrington, PA 18976
Re:WINDTREE THERAPEUTICS INC /DE/
Revised Preliminary Proxy Statement on Schedule 14A
Filed December 23, 2022
File No. 001-39290
Dear John Hamill:
            We have reviewed your filing and have the following comments.  In some of our
comments, we may ask you to provide us with information so we may better understand your
disclosure.
            Please respond to these comments within ten business days by providing the requested
information or advise us as soon as possible when you will respond.  If you do not believe our
comments apply to your facts and circumstances, please tell us why in your response.
            After reviewing your response to these comments, we may have additional comments.
Revised Preliminary Proxy Statement filed December 23, 2022
General
1.Please revise your disclosure to clearly state that the mirrored voting function of the Series
A Preferred Stock will have a significant impact on the vote needed to pass Proposal 1
relating to the reverse stock split. In this regard, assuming the minimum quorum is met
with no additional shares of common stock appearing in person or by proxy, it appears the
mirrored voting mechanism of the Series A Preferred Stock will result in the company
only needing 16.667% (1/6) of the common shares outstanding to vote in favor of
Proposal 1 rather than a vote in favor of at least 50.001%. Please clearly disclose these
figures, expressed as percentages, so shareholders may understand the impact the Series A
Preferred Stock will have on the ability of the company to pass Proposal 1.
2.We note the following statement included in your response to our prior comment 5:
"whether the approval of an amendment to the Amended and Restated Certificate of
Incorporation such as the one contemplated in the Preliminary Proxy Statement through a

 FirstName LastNameJohn Hamill
 Comapany NameWINDTREE THERAPEUTICS INC /DE/
 January 5, 2023 Page 2
 FirstName LastName
John Hamill
WINDTREE THERAPEUTICS INC /DE/
January 5, 2023
Page 2
vote which includes the vote of a super-voting preferred stock alters or changes the
powers, preferences, or special rights of the Common Stock so as to affect them adversely
(as set forth in Section 242(b) of the Delaware General Corporation Law (the “DGCL”))
has not been determined by a Delaware court to date and is not specifically provided for in
the applicable statutes." Please include the substance of this statement in the proxy
statement itself and discuss the surrounding uncertainty of using this approach in an
attempt to pass Proposal 1.
            We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
            Please contact Lauren Hamill at 303-844-1008 or Laura Crotty at 202-551-7614 with any
other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Jennifer Porter

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			Troutman Pepper Hamilton Sanders LLP

			3000 Two Logan Square, Eighteenth and Arch Streets

			Philadelphia, PA 19103-2799

			troutman.com

December 23, 2022

VIA EDGAR

U.S. Securities and Exchange Commission

100 F. Street, N.E.

Washington, D.C. 20549

Attention: Lauren Sprague Hamill and Laura Crotty

			Re:

			Windtree Therapeutics, Inc.

			Amended Preliminary Proxy Statement on Schedule 14A

			Filed December 12, 2022

			File No. 001-39290

Ladies and Gentlemen:

We are submitting this letter on behalf of our client Windtree Therapeutics, Inc. (the “Company”), in response to the written comments of the staff (the “Staff”) of the U.S. Securities and Exchange Commission (the “SEC”) contained in your letter, dated December 21, 2022 (the “Comment Letter”) in connection with the Company’s Amended Preliminary Proxy Statement on Schedule 14A (the “PRER14A”), filed on December 12, 2022. In response to the comments set forth in the Comment Letter the Company has revised the PRER14A and is filing a revised draft (the “Amended PRER14A”) with this response letter.

For your convenience, our responses are set forth below, with the headings and numbered items of this letter corresponding to the headings and numbered items contained in the Comment Letter. Each of the comments from the Comment Letter is restated in bold and italics prior to the Company’s response. Capitalized terms used but not defined in this letter shall have the respective meanings given to such terms in the Amended PRER14A.

Amended Preliminary Proxy Statement on Schedule 14A filed December 12, 2022

Stockholders Entitled to Vote, page 5

			1.

			We note your response to our prior comment 2 and your statement on page 5 that shareholders who choose not to cast a vote will have their shares of Series A Preferred Stock redeemed in the Initial Redemption. Please tell us how this statement is consistent with your statement on page 6 that registered stockholders can virtually attend and vote online during the Special Meeting. In this regard, clarify when during the course of the Special Meeting the Initial Redemption, quorum call, and opening of the polls will occur.

			Securities and Exchange Commission

			December 23, 2022

			Page 2

The Company respectfully advises the Staff that any holder of Series A Preferred Stock present at the Special Meeting virtually in person or by proxy shall not have their shares of Series A Preferred Stock redeemed in the Initial Redemption. Such holders can choose to attend the Special Meeting and abstain from voting on any or all of the proposals subject to a vote at the Special Meeting.

Furthermore, the Company respectfully advises the Staff that the Initial Redemption will occur after the quorum call and before opening of the polls at the Special Meeting. Pursuant to Nasdaq Listing Rule 5620(c), in no case shall a quorum be less than 33 1/3% of the Company’s common voting stock. If at least 33 1/3% of the Company’s common voting stock held as of the Record Date is represented in person or by proxy at the Special Meeting, then an equal or greater percentage of Series A Preferred Stock shall also be deemed to be present, and therefore a quorum shall have been achieved at the Special Meeting. Conversely, if fewer than 33 1/3% of the Company’s common voting stock held as of the Record Date is represented in person or by proxy at the Special Meeting, then a quorum shall not be achieved. As a result, neither the Series A Preferred Stock, nor the Initial Redemption thereof, has any practical effect on the Company’s ability to achieve a quorum.

The Company has revised its disclosure on page 5 of the Amended PRER14A as follows:

“The Initial Redemption will occur after the quorum call and before opening of the polls at the Special Meeting.  A holder’s shares of Series A Preferred Stock will be redeemed in the Initial Redemption if (1) such holder does not submit a proxy to vote its shares of Common Stock and Series A Preferred Stock at the Special Meeting (or revokes a submitted proxy prior to the Special Meeting); and (2) such holder is not present at the Special Meeting virtually in person or by proxy before opening of the polls at the Special Meeting.  If a holder is present at the Special Meeting virtually in person or by proxy prior to the opening of the polls at the Special Meeting, such holder’s Series A Preferred Stock shall not be redeemed in the Initial Redemption and shall be deemed outstanding for purposes of the Special Meeting.

Additionally, if a holder of the Company’s Common Stock submits a proxy to vote its shares of Common Stock and Series A Preferred Stock, and subsequently revokes such proxy prior to the opening of the polls at the Special Meeting, any shares of Series A Preferred Stock held by such holder shall be redeemed in the Initial Redemption, unless such holder is present at the Special Meeting virtually in person prior to the opening of the polls at the Special Meeting, in which case such holder’s Series A Preferred Stock shall not be redeemed in the Initial Redemption and shall be deemed outstanding for purposes of the Special Meeting.”

			Securities and Exchange Commission

			December 23, 2022

			Page 3

General

			2.

			Please state in the forepart of your proxy that the issuance of the Series A Preferred is to help the company attain quorum at the special meeting by increasing the total number of votes stockholders voting at the meeting are entitled to cast on the proposals.

The Company respectfully advises the Staff that the existence of the Series A Preferred Stock does not help the Company obtain a quorum. Pursuant to the Company’s Amended and Restated By-Laws, the presence, in person or by proxy, of one-third (1/3) of the votes of the shares of stock of the Company issued, outstanding and entitled to vote shall be present in person or by proxy to constitute a quorum at any meeting of stockholders. Additionally, Nasdaq Listing Rule 5620(c) provides that in no case shall a quorum be less than 33 1/3% of the Company’s common voting stock. As such, and pursuant to the Company’s By-Laws and Nasdaq Listing Rule 5620(c), the existence of the Series A Preferred Stock does not impact the requirement that at least 33 1/3% of the Company’s common stock must be present in person or by proxy for the Company to obtain a quorum at the Special Meeting, which is required regardless of the existence of the Series A Preferred Stock. The Company advises the Staff that the Proxy Statement contains disclosure indicating that “[a] quorum consists of the presence at the Special Meeting either attending the meeting virtually or represented by proxy of the holders of one-third (1/3) of the votes stockholders are entitled to cast at the Special Meeting, and such quorum must include at least one-third (1/3) of the votes represented by our Common Stock.”

			3.

			We note your response to our prior comment 4. Please further revise your disclosure to clearly state the consequences to stockholders if they do not vote their common shares in person or by proxy. In this regard, please state the likelihood that even if a shareholder does not vote on the proposals the company will attain quorum at the meeting and the proposals will be approved or disapproved.

The Company respectfully advises the Staff that, as discussed in response 2 above, the existence of the Series A Preferred Stock does not increase the likelihood of obtaining a quorum at the Special Meeting. The Company respectfully advises the Staff further that it has updated its disclosure as set forth in response 1 above, and on page 5 of the Amended PRER14A as follows:

“Even if a holder of the Company’s Common Stock chooses to not cast a vote on the matters to be voted upon at the Special Meeting, the Company believes that the existence of the Series A Preferred Stock increases the likelihood that the Reverse Stock Split Proposal will be approved due to its amplified voting power, which may be further amplified as a result of the Initial Redemption. However, since holders of the Series A Preferred Stock have the opportunity to vote against the Reverse Stock Split Proposal, the Company may be unable to obtain the vote of the requisite voting power required to approve the Reverse Stock Split Proposal. In addition, if a holder of Series A Preferred Stock attends the Special Meeting virtually in person or by proxy and abstains from voting on the Reverse Stock Split Proposal, such holder’s Series A Preferred Stock shall not be redeemed in the Initial Redemption, and such abstention will be treated as a vote against the Reverse Stock Split Proposal.”

			Securities and Exchange Commission

			December 23, 2022

			Page 4

			4.

			Based on the number of shares reported outstanding in the proxy statement and assuming the Series A Preferred is voted as described in the proxy statement, please clarify the number of votes that will need to be cast (i.e., the number of common shares that will need to be voted) to attain quorum at the special meeting and approve the proposals.

The Company respectfully advises the staff that it has revised its disclosure by adding the following paragraph on page 8 of the Amended PRER14A as follows:

“There were 38,610,119 shares of Common Stock and 38,610.119 shares of Series A Preferred Stock outstanding on the Record Date. If no shares of Series A Preferred Stock are redeemed in the Initial Redemption, (a) a quorum shall consist of the presence, virtually in person or by proxy, of at least (i) shares of Common Stock and Series A Preferred Stock representing 12,882,909,707 total votes, and (ii) 12,870,040 shares of Common Stock, (b) the Reverse Stock Split Proposal shall require the affirmative vote of at least 19,324,364,560 total votes, and (c) the Adjournment Proposal shall require a majority of the total votes cast. The thresholds required to approve the proposals at this Special Meeting shall be reduced proportionally as a result of any shares of Series A Preferred Stock redeemed in the Initial Redemption, however, in no event shall such Initial Redemption impact the requirement under Nasdaq Listing Rule 5620(c) that at least 33 1/3% of the Company’s Common Stock must be present, virtually in person or by proxy, to obtain a quorum.”

			5.

			We have reviewed the opinion you provided in response to our prior comment 6. Please explain why the following assumption is required: “(f) the amendments to the Charter contemplated by the Preliminary Proxy Statement do not alter or change the powers, preferences, or special rights of the Common Stock so as to affect them adversely for all purposes.” Alternatively, provide a revised opinion that does not include this language.

The Company respectfully advises the Staff that its counsel has removed the referenced assumption and has submitted a new opinion as Annex A hereto.  The Company’s counsel had included the assumption above in the opinion because whether the approval of an amendment to the Amended and Restated Certificate of Incorporation such as the one contemplated in the Preliminary Proxy Statement through a vote which includes the vote of a super-voting preferred stock alters or changes the powers, preferences, or special rights of the Common Stock so as to affect them adversely (as set forth in Section 242(b) of the Delaware General Corporation Law (the “DGCL”)) has not been determined by a Delaware court to date and is not specifically provided for in the applicable statutes.  Legal opinions are to be delivered only in cases where there is clear statutory or precedent guidance. The Company’s counsel believes that if the position was briefed and argued before a Delaware court, such Delaware court should support the position, but given the lack of statutory clarity or direct precedent in this area, the Company’s counsel included the assumption (set forth in clause (f) of the opinion) that a Delaware court would reach this conclusion, which is based on counsel’s research and interpretation of analogous but not controlling points.  However, there is not enough statutory or direct case support to say for legal opinion purposes whether a vote at the Special Meeting which represented less than a majority of the outstanding shares of Common Stock of the Company would be sufficient to approve the amendment to the Amended and Restated Certificate of Incorporation under Section 242(b) of the DGCL. Notwithstanding, because the assumption is not necessary for the numbered opinions 1, 2 or 3 of the opinion provided herewith, counsel has removed the assumption.

			Securities and Exchange Commission

			December 23, 2022

			Page 5

We thank you for your prompt attention to this letter responding to the Staff’s Comment Letter and look forward to hearing from you at your earliest convenience. Please direct any questions concerning this filing to the undersigned at 215.981.4339.

			Sincerely,

			/s/ Jennifer L. Porter, Esq.

			     Jennifer L. Porter, Esq.

			cc:

			Via Email

			John Hamill, Windtree Therapeutics, Inc.

			Rachael M. Bushey, Troutman Pepper Hamilton Sanders LLP

ANNEX A

Troutman Pepper Opinion

(See Attached)

			Troutman Pepper Hamilton Sanders LLP

			3000 Two Logan Square, Eighteenth and Arch Streets

			Philadelphia, PA 19103-2799

			troutman.com

December 23, 2022

Board of Directors

Windtree Therapeutics, Inc.

Re:         Series A Preferred Stock

Ladies and Gentlemen:

We have acted as counsel to Windtree Therapeutics, Inc., a Delaware corporation (the “Corporation”), in connection with certain matters related to the voting rights and redemption terms under Delaware law of the Corporation’s Series A Preferred Stock, par value $0.001 per share (the “Series A Preferred Stock”), as established by the Certificate of Designation of Series A Preferred Stock, as filed by the Corporation with the Delaware Secretary of State on November 18, 2022. We provide this letter pursuant to Comment No. 5 (“Comment No. 5”) provided in that certain comment letter from the United States Securities and Exchange Commission (the “Commission”), dated December 21, 2022 (the “Comment Letter”), related to the Corporation’s Preliminary Proxy Statement on Schedule 14A, as filed with the Commission on November 22, 2022, as amended on December 12, 2022 (the “Preliminary Proxy Statement”).

In response to Comment No. 5, we reviewed the following: (a) the Amended and Restated Certificate of Incorporation of the Corporation, as filed with the Delaware Secretary of State on February 15, 2018, as amended (the “Charter”); (b) the Amended and Restated Bylaws of the Corporation, effective as of April 19, 2016, as amended; (c) the resolutions adopted by the Corporation’s board of directors (the “Board”), dated November 18, 2022, declaring a dividend of one one-thousandth (1/1,000th) of a share of Series A Preferred Stock for each outstanding share of Common Stock, par value $0.001 per share (the “Common Stock”), to stockholders of record of Common Stock as of 5:00 p.m. Eastern Time on November 28, 2022; (d) the Preliminary Proxy Statement; and (e) the relevant portions of the Delaware General Corporation Law (the “DGCL”). In addition, we have also examined such corporate records and other agreements, documents and instruments, and such certificates or comparable documents of public officials and officers and representatives of the Corporation and have made such inquiries of such officers and representatives and have considered such matters of law as we have deemed appropriate as the basis for the opinions hereinafter set forth.

			Securities and Exchange Commission

			December 23, 2022

			Page 2

As a preliminary matter, we note that, pursuant to Section 151(a) of the DGCL, every corporation may issue one or more classes of stock or one or more series of stock within any class thereof, any or all of which classes m

United States securities and exchange commission logo
December 21, 2022
John Hamill
Chief Financial Officer
WINDTREE THERAPEUTICS INC /DE/
2600 Kelly Road, Suite 100
Warrington, PA 18976
Re:WINDTREE THERAPEUTICS INC /DE/
Amended Preliminary Proxy Statement on Schedule 14A
Filed December 12, 2022
File No. 001-39290
Dear John Hamill:
            We have reviewed your filing and have the following comments.  In some of our
comments, we may ask you to provide us with information so we may better understand your
disclosure.
            Please respond to these comments within ten business days by providing the requested
information or advise us as soon as possible when you will respond.  If you do not believe our
comments apply to your facts and circumstances, please tell us why in your response.
            After reviewing your response to these comments, we may have additional comments.
Amended Preliminary Proxy Statement on Schedule 14A filed December 12, 2022
Stockholders Entitled to Vote, page 5
1.We note your response to our prior comment 2 and your statement on page 5 that
shareholders who choose not to cast a vote will have their shares of Series A Preferred
Stock redeemed in the Initial Redemption. Please tell us how this statement is consistent
with your statement on page 6 that registered stockholders can virtually attend and vote
online during the Special Meeting. In this regard, clarify when during the course of
the Special Meeting the Initial Redemption, quorum call, and opening of the polls will
occur.
General
2.Please state in the forepart of your proxy that the issuance of the Series A Preferred is to
help the company attain quorum at the special meeting by increasing the total number of
votes stockholders voting at the meeting are entitled to cast on the proposals.

 FirstName LastNameJohn Hamill
 Comapany NameWINDTREE THERAPEUTICS INC /DE/
 December 21, 2022 Page 2
 FirstName LastName
John Hamill
WINDTREE THERAPEUTICS INC /DE/
December 21, 2022
Page 2
3.We note your response to our prior comment 4. Please further revise your disclosure to
clearly state the consequences to stockholders if they do not vote their common shares in
person or by proxy. In this regard, please state the likelihood that even if a shareholder
does not vote on the proposals the company will attain quorum at the meeting and the
proposals will be approved or disapproved.
4.Based on the number of shares reported outstanding in the proxy statement and assuming
the Series A Preferred is voted as described in the proxy statement, please clarify the
number of votes that will need to be cast (i.e., the number of common shares that will
need to be voted) to attain quorum at the special meeting and approve the proposals.
5.We have reviewed the opinion you provided in response to our prior comment 6. Please
explain why the following assumption is required: “(f) the amendments to the Charter
contemplated by the Preliminary Proxy Statement do not alter or change the powers,
preferences, or special rights of the Common Stock so as to affect them adversely for all
purposes.”  Alternatively, provide a revised opinion that does not include this language.

            We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
            You may contact Lauren Sprague Hamill at 303-844-1008 or Laura Crotty at 202-551-
7614 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Jennifer Porter

CORRESP
1
filename1.htm

	wint20221212_corresp.htm

			Troutman Pepper Hamilton Sanders LLP

			3000 Two Logan Square, Eighteenth and Arch Streets

			Philadelphia, PA 19103-2799

			troutman.com

  December 12, 2022

VIA EDGAR

U.S. Securities and Exchange Commission

100 F. Street, N.E.

Washington, D.C. 20549

Attention: Lauren Hamill and Laura Crotty

			Re:

			Windtree Therapeutics, Inc.

			Proxy Statement on Schedule 14A

			Filed November 22, 2022

			File No. 001-39290

Ladies and Gentlemen:

We are submitting this letter on behalf of our client Windtree Therapeutics, Inc. (the “Company”), in response to the written comments of the staff (the “Staff”) of the U.S. Securities and Exchange Commission (the “SEC”) contained in your letter, dated December 6, 2022 (the “Comment Letter”) in connection with the Company’s Preliminary Proxy Statement on Schedule 14A (the “PRE14A”), filed on November 22, 2022. In response to the comments set forth in the Comment Letter the Company has revised the PRE14A and is filing a revised draft (the “Amended PRE14A”) with this response letter.

For your convenience, our responses are set forth below, with the headings and numbered items of this letter corresponding to the headings and numbered items contained in the Comment Letter. Each of the comments from the Comment Letter is restated in bold and italics prior to the Company’s response. Capitalized terms used but not defined in this letter shall have the respective meanings given to such terms in the Amended PRE14A.

Amended Preliminary Proxy Statement on Schedule 14A filed November 28, 2022

Cover Page

			1.

			We note that on November 18, 2022, the Company's Board announced a declared dividend of 1/1,000th of a share of Series A Preferred Stock for each outstanding share of common stock to shareholders of record on November 28, 2022, which was distributed on December 2, 2022.

			●

			Please revise to explicitly state whether the dividend of the Series A Preferred Stock, with its attendant voting rights, was issued by the Company solely to affect the passage of the charter amendment to effect a reverse stock split of your common stock. If so, explain the reason(s) why the Board determined that such issuance was necessary in this case.

			Securities and Exchange Commission

			December 12, 2022

			Page 2

The Company respectfully advises the Staff that it has updated its disclosure to include the following paragraph:

“The Series A Preferred Stock was issued to solely affect the passage of a charter amendment to effect a reverse stock split. The Board determined that the issuance of the Series A Preferred Stock was desirable as the Company recently had difficulty obtaining a quorum at prior stockholder meetings, and obtaining the vote of at least 50% of its total voting power on matters submitted to stockholders, which is required to approve the Reverse Stock Split Proposal. The Board determined that the issuance of the Series A Preferred Stock would assist the Company in obtaining the legally required approval for the Reverse Stock Split Proposal under Delaware law and the Company’s organizational documents without disenfranchising voters. Voters would not be disenfranchised since all of the Company’s stockholders on the Series A Preferred Stock dividend record date received shares of Series A Preferred Stock, and all such holders, as well as any holders who purchased shares of Common Stock (and therefore Series A Preferred Stock) prior the Record Date, have the opportunity to vote for or against the Reverse Stock Split Proposal.”

			●

			Explain whether the Series A Preferred Stock voting rights will affect quorum and voting requirements at the special meeting and any adjournment thereof, and if so, how.

The Company respectfully advises the Staff that the Series A Preferred Stock does not impact the existing requirement under the Company's organizational documents and the Nasdaq listing rules that one-third (1/3) of the votes stockholders are entitled to at the Special Meeting (including one-third (1/3) of the voting power represented by our Common Stock) must be present, in person or by proxy, to establish a quorum. Additionally, the Series A Preferred Stock does not affect the requirement under the Company's organizational documents that the approval of a majority of the voting power of the capital stock of the Company is required to approve the Reverse Stock Split Proposal.

			2.

			You disclose that any whole or fractional shares of Series A Preferred Stock that are not present in person or by proxy "immediately prior to the opening of the polls" at the special meeting will be automatically redeemed in the Initial Redemption and no longer entitled to vote.

			●

			Please revise to clarify when the opening of the polls at the special meeting will occur.

			Securities and Exchange Commission

			December 12, 2022

			Page 3

The Company respectfully advises the Staff that it has updated its disclosure to state that the opening of the polls will occur at “approximately [   ] am, on [    ], 2023.” The Company intends to provide the bracketed information in a definitive proxy statement filed with the SEC once the date of the Special Meeting is finalized.

			●

			Revise to explicitly describe the outsized voting rights the holders of common stock with related Series A Preferred Stock will have relative to holders of common stock whose shares of Series A Preferred Stock were redeemed pursuant to the Initial Redemption. In this respect, please consider including an illustrative example of the effects the super voting rights of the Series A Preferred Stock will have on reaching both the quorum requirement and voting threshold necessary to approve the proposal.

The Company respectfully advises the Staff that it has updated its disclosure to include the following paragraphs:

“Each holder of one share of Common Stock that holds one one-thousandth (1/1,000th) of a share Series A Preferred Stock that is not redeemed in the Initial Redemption will have 1,001 votes with respect to the establishment of a quorum and the matters to be voted upon at the Special Meeting. Each holder of one share of Common Stock that holds one one-thousandth (1/1,000th) of a share Series A Preferred Stock that is redeemed in the Initial Redemption will have one vote with respect to the establishment of a quorum and the matters to be voted upon at the Special Meeting.”

“Shares of Series A Preferred Stock that are automatically redeemed in the Initial Redemption will not be counted towards the presence of a quorum or as part of the issued and outstanding shares of capital stock of the Company entitled to vote at the Company’s Special Meeting for purposes of determining the presence of a quorum or approval of the Reverse Stock Split Proposal. For illustrative purposes only, if the Company had 1,000,000 shares of Common Stock outstanding as of the Special Meeting record date, each with one vote per share, and 1,000 shares of Series A Preferred Stock, each with 1,000,000 votes per share, the total number of votes attributable to the Company’s capital stock would be 1,001,000,000. In this scenario, 333,666,667 votes (including one-third (1/3) of the voting power represented by our Common Stock) would be required to establish a quorum at the Special Meeting, and 500,500,001 votes would be required to approve the Reverse Stock Split Proposal. Further, if 500 shares of Series A Preferred Stock are redeemed in the Initial Redemption, the total number of votes attributable to the Company’s capital stock for purposes of the Special Meeting would be 501,000,000. In such scenario, 167,000,000 votes (including one-third (1/3) of the voting power represented by our Common Stock) would be required to establish a quorum at the Special Meeting, and 250,500,001 votes would be required to approve the Reverse Stock Split Proposal.”

			3.

			Please revise to clearly explain the voting differences between shares purchased prior to the November 28, 2022 record date for the Series A Preferred dividend compared with those purchased after that record date but before the December 2, 2022 special meeting record date. Conversely, because the Series A Preferred is nontransferable by the holder thereof except in connection with a transfer by such holder of any shares of common stock held by that holder, please clearly explain what happens with respect to the voting rights of any common shareholder that sells any common shares after the preferred stock dividend record date but before the meeting record date.

			Securities and Exchange Commission

			December 12, 2022

			Page 4

The Company respectfully advises the Staff that it has updated its disclosure to include the following paragraph:

“Any holder of shares of Common Stock that held such shares as of the Series A Preferred Stock Record Date on November 28, 2022 received a dividend of one one-thousandth (1/1,000th) of a share of Series A Preferred Stock for each share of Common Stock held by such holder, and is deemed to have the voting power attributable to both its shares of Common Stock and Series A Preferred Stock for purposes of the Special Meeting. Any holder that purchased any shares of Common Stock in the open market after the Series A Preferred Stock Record Date on November 28, 2022 and prior to the December 2, 2022 Special Meeting record date also received one one-thousandth (1/1,000th) of a share of Series A Preferred Stock for each share of Common Stock purchased by such holder and is deemed to have the voting power attributable to both its shares of Common Stock and Series A Preferred Stock for purposes of the Special Meeting. Conversely, the voting power held by any holder that sold any shares of Common Stock and Series A Preferred Stock after the Series A Preferred Stock Record Date on November 28, 2022 and prior to the December 2, 2022 Special Meeting record date is reduced in proportion to the number of shares of Common Stock and Series A Preferred Stock sold by such holder.”

			4.

			Please revise to clearly explain the consequence to shareholders of the Series A Preferred of:

			●

			Not casing a vote on a common share; and

			●

			Proxy revocation prior to the special meeting.

The Company respectfully advises the Staff that it has updated its disclosure to include the following language:

“If a holder of the Company’s Common Stock chooses to not cast a vote of its Common Stock on the matters to be voted upon at the Special Meeting, any shares of Series A Preferred Stock held by such holder shall be redeemed in the Initial Redemption. Additionally, if a holder of the Company’s Common Stock submits a proxy to vote its shares of Common Stock and Series A Preferred Stock, and subsequently revokes such proxy, thereby not casting its vote prior to opening of the polls at the Special Meeting, any shares of Series A Preferred Stock held by such holder shall be redeemed in the Initial Redemption.”

			5.

			Please advise us whether you have discussed the issuance and voting rights of the Series A Preferred Stock with Nasdaq and the outcome of such discussions.

			Securities and Exchange Commission

			December 12, 2022

			Page 5

The Company respectfully advises the Staff that it submitted a Nasdaq Non-cash Dividend/Distribution notice to NASDAQ on November 18, 2022, and received no comment or objection from Nasdaq. The Company further advises the Staff that its legal counsel has informed the Company that nearly identical preferred stock structures have been discussed with Nasdaq recently for other public companies, and Nasdaq has not objected to such structures.

			6.

			Please provide the opinion of counsel as to:

			●

			Whether the vote taken including votes represented by the Series A Preferred will be valid under Delaware law;

			●

			The legality under Delaware law of the redemption of all shares of Series A Preferred Stock that are not present in person or by proxy at the Special Meeting as of immediately prior to the opening of the polls at the Special Meeting; and

			●

			The legality under Delaware law of the further redemption of all remaining Series A Preferred (i) if and when ordered by your Board or (ii) automatically upon the approval by the Company’s stockholders of the reverse stock split proposal at any meeting of the stockholders held for the purpose of voting on such proposal.

The Company respectfully advises the Staff to please reference Troutman Pepper Hamilton Sanders LLP’s Opinion (“Troutman Pepper Opinion”), which is attached hereto as Annex A.

We thank you for your prompt attention to this letter responding to the Staff’s Comment Letter and look forward to hearing from you at your earliest convenience. Please direct any questions concerning this filing to the undersigned at 215.981.4339.

			Sincerely,

			/s/ Jennifer L. Porter, Esq.

			Jennifer L. Porter, Esq

.

			cc:

			Via Email

			John Hamill, Windtree Therapeutics, Inc.

			Rachael M. Bushey, Troutman Pepper Hamilton Sanders LLP

ANNEX A

Troutman Pepper Opinion

(See Attached)

			Troutman Pepper Hamilton Sanders LLP

			3000 Two Logan Square, Eighteenth and Arch Streets

			Philadelphia, PA 19103-2799

			troutman.com

December 12, 2022

Board of Directors

Windtree Therapeutics, Inc.

Re:         Series A Preferred Stock

Ladies and Gentlemen:

We have acted as counsel to Windtree Therapeutics, Inc., a Delaware corporation (the “Corporation”), in connection with certain matters related to the voting rights and redemption terms under Delaware law of the Corporation’s Series A Preferred Stock, par value $0.001 per share (the “Series A Preferred Stock”), as established by the Certificate of Designation of Series A Preferred Stock, as filed by the Corporation with the Delaware Secretary of State on November 18, 2022. We provide this letter pursuant to Comment No. 6 (“Comment No. 6”) provided in that certain comment letter from the United States Securities and Exchange Commission (the “Commission”), dated December 6 (the “Comment Letter”), related to the Corporation’s Preliminary Proxy Statement on Schedule 14A, as filed with the Commission on November 22, 2022 (the “Preliminary Proxy Statement”).

In response to Comment No. 6, we reviewed the following: (a) the Amended and Restated Certificate of Incorporation of the Corporation, as filed with the Delaware Secretary of State on February 15, 2018, as amended (the “Charter”); (b) the Amended and Restated Bylaws of the Corporation, effective as of April 19, 2016, as amended; (c) the resolutions adopted by the Corporation’s board of directors (the “Board”), dated November 18, 2022, declaring a dividend of one one-thousandth (1/1,000th) of a share of Series A Preferred Stock for each outstanding share of Common Stock, par value $0.001 per share (the “Common Stock”), to stockholders of record of Common Stock as of 5:00 p.m. Eastern Time on November 28, 2022; (d) the Preliminary Proxy Statement; and (e) the relevant portions of the Delaware General Corporation Law (the “DGCL”). In addition, we have also examined such corporate records and other agreements, documents and instruments, and such certificates or comparable documents of public officials and officers and representatives of the Corporation and have made such inquiries of such officers and representatives and have considered such matters of law as we have deemed appropriate as the basis for the opinions hereinafter set forth.

			Securities and Exchange Commission

			December 12, 2022

			Page 2

As a preliminary matter, we note that, pursuant to Section 151(a) of the DGCL, every corporation may issue one or more classes of stock or one or more series of stock within any class thereof, any or all of which classes may have such voting powers, full or limited, or no voting powers, and such designations, preferences and relative, participating, optional or other special right

United States securities and exchange commission logo
December 6, 2022
John Hamill
Chief Financial Officer
WINDTREE THERAPEUTICS INC /DE/
2600 Kelly Road, Suite 100
Warrington, PA 18976
Re:WINDTREE THERAPEUTICS INC /DE/
Proxy Statement on Schedule 14A
Filed November 22, 2022
File No. 001-39290
Dear John Hamill:
            We have reviewed your filing and have the following comments.  In some of our
comments, we may ask you to provide us with information so we may better understand your
disclosure.
            Please respond to these comments within ten business days by providing the requested
information or advise us as soon as possible when you will respond.  If you do not believe our
comments apply to your facts and circumstances, please tell us why in your response.
            After reviewing your response to these comments, we may have additional comments.
Proxy Statement on Schedule 14A filed November 22, 2022
General
1.We note that on November 18, 2022, the Company's Board announced a declared
dividend of 1/1,000th of a share of Series A Preferred Stock for each outstanding share of
common stock to shareholders of record on November 28, 2022, which was distributed on
December 2, 2022.
•Please revise to explicitly state whether the dividend of the Series A Preferred Stock,
with its attendant voting rights, was issued by the Company solely to affect the
passage of the charter amendment to effect a reverse stock split of your common
stock. If so, explain the reason(s) why the Board determined that such issuance was
necessary in this case.
•Explain whether the Series A Preferred Stock voting rights will affect quorum and
voting requirements at the special meeting and any adjournment thereof, and if so,
how.

 FirstName LastNameJohn Hamill
 Comapany NameWINDTREE THERAPEUTICS INC /DE/
 December 6, 2022 Page 2
 FirstName LastName
John Hamill
WINDTREE THERAPEUTICS INC /DE/
December 6, 2022
Page 2
2.You disclose that any whole or fractional shares of Series A Preferred Stock that are not
present in person or by proxy "immediately prior to the opening of the polls" at the special
meeting will be automatically redeemed in the Initial Redemption and no longer entitled
to vote.
•Please revise to clarify when the opening of the polls at the special meeting will
occur.
•Revise to explicitly describe the outsized voting rights the holders of common stock
with related Series A Preferred Stock will have relative to holders of common stock
whose shares of Series A Preferred Stock were redeemed pursuant to the Initial
Redemption. In this respect, please consider including an illustrative example of the
effects the super voting rights of the Series A Preferred Stock will have on reaching
both the quorum requirement and voting threshold necessary to approve the
proposal.
3.Please revise to clearly explain the voting differences between shares purchased prior to
the November 28, 2022 record date for the Series A Preferred dividend compared with
those purchased after that record date but before the December 2, 2022 special meeting
record date.  Conversely, because the Series A Preferred is nontransferable by the holder
thereof except in connection with a transfer by such holder of any shares of common stock
held by that holder, please clearly explain what happens with respect to the voting rights
of any common shareholder that sells any common shares after the preferred stock
dividend record date but before the meeting record date.
4.Please revise to clearly explain the consequence to shareholders of the Series A Preferred
of:
•Not casting a vote on a common share; and
•Proxy revocation prior to the special meeting.
5.Please advise us whether you have discussed the issuance and voting rights of the Series A
Preferred Stock with Nasdaq and the outcome of such discussions.
6.Please provide the opinion of counsel as to:
•Whether the vote taken including votes represented by the Series A Preferred will be
valid under Delaware law;
•The legality under Delaware law of the redemption of all shares of Series A Preferred
Stock that are not present in person or by proxy at the Special Meeting as of
immediately prior to the opening of the polls at the Special Meeting; and
•The legality under Delaware law of the further redemption of all remaining Series A
Preferred (i) if and when ordered by your Board or (ii) automatically upon the
approval by the Company’s stockholders of the reverse stock split proposal at any
meeting of the stockholders held for the purpose of voting on such proposal.

 FirstName LastNameJohn Hamill
 Comapany NameWINDTREE THERAPEUTICS INC /DE/
 December 6, 2022 Page 3
 FirstName LastName
John Hamill
WINDTREE THERAPEUTICS INC /DE/
December 6, 2022
Page 3
            We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
            Please contact Lauren Hamill at 303-844-1008 or Laura Crotty at 202-551-7614 with any
other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Jennifer Porter

United States securities and exchange commission logo
December 29, 2021
Diane Carman, Esq.
Senior Vice President and General Counsel
WINDTREE THERAPEUTICS, INC.
2600 Kelly Road, Suite 100
Warrington, Pennsylvania 18976
Re:WINDTREE THERAPEUTICS, INC.
Registration Statement on Form S-3
Filed December 23, 2021
File No. 333-261878
Dear Ms. Carman:
            This is to advise you that we have not reviewed and will not review your registration
statement.
            Please refer to Rules 460 and 461 regarding requests for acceleration.  We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
            Please contact Daniel Crawford at 202-551-7767 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Rachael Bushey

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Windtree Therapeutics, Inc.

2600 Kelly Road, Suite 100

Warrington, PA 18976

December 29, 2021

VIA EDGAR

United States Securities and Exchange Commission

Division of Corporation Finance

Office of Life Sciences

100 F Street NE

Washington, D.C. 20549

Attn: Daniel Crawford

			Re:

			Windtree Therapeutics, Inc.

			Registration Statement on Form S-3

			Filed December 23, 2021 (File No. 333- 261878)

Ladies and Gentlemen:

Pursuant to Rule 461 under the Securities Act of 1933, as amended, Windtree Therapeutics, Inc. (the “Company”) hereby requests that the effective date of the Company’s Registration Statement on Form S-3 (File No. 333-261878) (the “Registration Statement”) be accelerated so that the Company’s Registration Statement will become effective at 4:01 PM, Eastern Time, on January 3, 2022, or as soon thereafter as is practicable.

Please contact Rachael M. Bushey, Esq. of Troutman Pepper Hamilton Sanders LLP, counsel to the Company, at (215) 981-4331 to provide notice of effectiveness, or if you have any questions or comments concerning this request.

[Remainder of the page intentionally left blank]

			Very truly yours,

			WINDTREE THERAPEUTICS, INC.

			By:

			 /s/ Diane Carman

			Name:

			Diane Carman

			Title:

			Senior Vice President and General Counsel

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Windtree Therapeutics, Inc.

2600 Kelly Road, Suite 100

Warrington, PA 18976

September 28, 2020

VIA EDGAR

United States Securities and Exchange Commission

Division of Corporation Finance

Office of Life Sciences

100 F Street NE

Washington, D.C. 20549

Attn: Laura Crotty and Celeste Murphy

Re:         Windtree Therapeutics, Inc.

Registration Statement on Form S-3

Filed September 17, 2020 (File No. 333-248874)

Ladies and Gentlemen:

Pursuant to Rule 461 under the Securities Act of 1933, as amended, Windtree Therapeutics, Inc. (the “Company”) hereby requests that the effective date of the Company’s Registration Statement on Form S-3 (File No. 333-248874) (the “Registration Statement”) be accelerated so that the Company’s Registration Statement will become effective at 4:01 PM, Eastern Time, on September 29, 2020, or as soon thereafter as is practicable.

Please contact Rachael M. Bushey, Esq. of Troutman Pepper Hamilton Sanders LLP, counsel to the Company, at (215) 981-4331 to provide notice of effectiveness, or if you have any questions or comments concerning this request.

[Remainder of the page intentionally left blank]

			Very truly yours,

			WINDTREE THERAPEUTICS, INC.

			By:

			 /s/ Craig E. Fraser

			Name:

			Craig E. Fraser

			Title:

			President and Chief Executive Officer

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			Troutman Pepper Hamilton Sanders LLP

			3000 Two Logan Square, Eighteenth and Arch Streets

			Philadelphia, PA 19103-2799

			troutman.com

September 24, 2020

VIA EDGAR AND OVERNIGHT MAIL

U.S. Securities and Exchange Commission

100 F. Street, N.E.

Washington, D.C.  20549

Attention:  Laura Crotty and Celeste Murphy

			Re: Windtree Therapeutics, Inc.

			Registration Statement on Form S-3

			Filed September 17, 2020

			File No. 333-248874

Ladies and Gentlemen:

We are in receipt of the letter dated September 22, 2020 from the Staff (the “Staff”) of the U.S. Securities and Exchange Commission with respect to the above-referenced Registration Statement (the “Registration Statement”). We are responding to the Staff’s comment on behalf of Windtree Therapeutics, Inc. (“Windtree” or the “Company”) as set forth below. For ease of reference, we have set forth the Staff’s comment and the response below.

Registration Statement on Form S-3 filed on September 17, 2020

Cover Page

			1.

			It appears that you are relying on General Instruction I.B.6 of Form S-3. If true, please revise your prospectus cover page to disclose the calculation of the aggregate market value of your outstanding voting and nonvoting common equity and the amount of all securities offered pursuant to General Instruction I.B.6 during the prior 12 calendar month period that ends on, and includes, the date of the prospectus. Refer to Instruction 7 to General Instruction I.B.6. Otherwise, please provide us your analysis demonstrating your eligibility to use Form S-3.

Response: Windtree respectfully advises the Staff that the Registration Statement was filed pursuant to General Instruction I.B.1 of Form S-3, and not General Instruction I.B.6 of Form S-3. The analysis set forth below demonstrates that the aggregate market value of the voting and non-voting common equity held by non-affiliates of Windtree is more than $75,000,000, as required pursuant to General Instruction I.B.1 of Form S-3.

			U.S. Securities and Exchange Commission

			September 24, 2020

			Page 2

As of September 17, 2020, 16,886,482 shares of common equity of the Company was outstanding, of which 9,579,542 shares of common equity were held by non-affiliates of the Company and 7,306,940 shares of common equity were held by affiliates of the Company. As of August 3, 2020, a date which was within 60 days prior to the date the Registration Statement was filed, the closing price of the Company’s common stock on The Nasdaq Capital Market was $9.90 per share. Pursuant to Compliance and Disclosure Interpretation 116.06, the date used to determine the amount of shares of common equity held by non-affiliates and the price of the common equity need not be the same. As such, the Company’s public float was $94,837,465.80 (9,579,542 shares of common equity held by non-affiliates, times $9.90 per share) as of the applicable calculation date of September 17, 2020 making the Company eligible to use Form S-3 pursuant to General Instruction I.B.1.

* * *

Thank you for your assistance in this matter. If you have any questions or comments regarding the foregoing, please do not hesitate to contact the undersigned at (215) 981-4339.

			Very truly yours,

			/s/ Rachael M. Bushey

			Rachael M. Bushey

cc:  Craig E. Fraser , Windtree Therapeutics, Inc.

John P. Hamill Windtree Therapeutics, Inc.

Jennifer L. Porter, Troutman Pepper Hamilton Sanders LLP

United States securities and exchange commission logo
September 22, 2020
John Hamill
Chief Financial Officer
WINDTREE THERAPEUTICS INC /DE/
2600 Kelly Road, Suite 100
Warrington, Pennsylvania 18976
Re:WINDTREE THERAPEUTICS INC /DE/
Registration Statement on Form S-3
Filed September 17, 2020
File No. 333-248874
Dear Mr. Hamill:
            We have limited our review of your registration statement to those issues we have
addressed in our comment.  In our comment, we may ask you to provide us with information so
we may better understand your disclosure.
            Please respond to this letter by amending your registration statement and providing the
requested information.  If you do not believe our comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
            After reviewing any amendment to your registration statement and the information you
provide in response to this comment, we may have additional comments.
Form S-3 filed September 17, 2020
Cover Page
1.It appears that you are relying on General Instruction I.B.6 of Form S-3.  If true, please
revise your prospectus cover page to disclose the calculation of the aggregate market
value of your outstanding voting and nonvoting common equity and the amount of all
securities offered pursuant to General Instruction I.B.6 during the prior 12 calendar month
period that ends on, and includes, the date of the prospectus.  Refer to Instruction 7 to
General Instruction I.B.6.  Otherwise, please provide us your analysis demonstrating your
eligibility to use Form S-3.
            We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of

 FirstName LastNameJohn  Hamill
 Comapany NameWINDTREE THERAPEUTICS INC /DE/
 September 22, 2020 Page 2
 FirstName LastName
John  Hamill
WINDTREE THERAPEUTICS INC /DE/
September 22, 2020
Page 2
action by the staff.
            Refer to Rules 460 and 461 regarding requests for acceleration.  Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
            Please contact Laura Crotty at 202-551-7614 or Celeste Murphy at 202-551-3257 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Rachael Bushey

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Windtree Therapeutics, Inc.

2600 Kelly Road, Suite 100

Warrington, PA 18976

May 15, 2020

VIA EDGAR

United States Securities and Exchange Commission

Division of Corporation Finance

Office of Manufacturing

100 F Street NE

Washington, D.C. 20549

Attn: Jeffery Gabor

			Re:

			Windtree Therapeutics, Inc.

			Registration Statement on Form S-1

			SEC File No. 333-236085

			Filed January 27, 2020

Ladies and Gentlemen:

Pursuant to Rule 461 under the Securities Act of 1933, as amended, Windtree Therapeutics, Inc. (the “Company”) hereby requests that the effective date of the Company’s Registration Statement on Form S-1 (File No. 333-236085) (the “Registration Statement”) be accelerated so that the Company’s Registration Statement will become effective at 5:00 PM, eastern time, on May 18, 2020, or as soon thereafter as is practicable.

Please feel free to direct any questions or comments concerning this request to Rachael Bushey, Esq. of Pepper Hamilton LLP at (215) 981-4331.

The Company understands that the staff of the United States Securities and Exchange Commission will consider this request as confirmation by the Company that it is aware of its responsibilities under the federal securities laws as they relate to the issuance of the securities covered by the Registration Statement.

			WINDTREE THERAPEUTICS, INC.

			By:

			/s/ Craig E. Fraser

			Name: Craig E. Fraser

			Title: President, Chief Executive Officer

Cc: Rachael Bushey, Pepper Hamilton LLP

Windtree Therapeutics, Inc. – Acceleration Letter

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Ladenburg Thalmann & Co. Inc.

999 Vanderbilt Beach Road, Suite 200

Naples, Florida 34108

May 15, 2020

VIA FACSIMILE AND EDGAR

U.S. Securities and Exchange Commission

Division of Corporation Finance

Washington, DC 20549

			Re:

			WINDTREE THERAPEUTICS, Inc.

			Registration Statement on Form S-1 (Registration No. 333-236085)

			Concurrence in Acceleration Request

Ladies and Gentlemen:

Ladenburg Thalmann & Co. Inc. (“Ladenburg”), as representative of the underwriters for the referenced offering, hereby concurs in the request by Windtree Therapeutics, Inc. that the effective date of the above-referenced registration statement be accelerated to 5:00 p.m. (Eastern Time), or as soon as practicable thereafter, on May 18, 2020, pursuant to Rule 461 under the Securities Act. Ladenburg affirms that it is aware of its obligations under the Securities Act in connection with this offering.

			Very truly yours,

			LADENBURG THALMANN & CO. INC.

			By:

			/s/ Nicholas Stergis

			Name: Nicholas Stergis

			Title: Managing Director

January 30, 2020
Craig E. Fraser
President and Chief Executive Officer
Windtree Therapeutics, Inc.
2600 Kelly Road, Suite 100
Warrington, PA 18976
Re:Windtree Therapeutics, Inc.
Registration Statement on Form S-1
Filed January 27, 2020
File No. 333-236085
Dear Mr. Fraser:
            This is to advise you that we have not reviewed and will not review your registration
statement.
            Please refer to Rules 460 and 461 regarding requests for acceleration.  We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
            Please contact Jeffrey Gabor at 202-551-2544 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Rachael M. Bushey, Esq.

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Windtree Therapeutics, Inc.

2600 Kelly Road, Suite 100

Warrington, PA 18976

January 28, 2020

VIA EDGAR

United States Securities and Exchange Commission

Division of Corporation Finance

Office of Life Sciences

100 F Street NE

Washington, D.C. 20549

Attn: Jeffrey Gabor

			Re:
			Windtree Therapeutics, Inc.

			Registration Statement on Form S-1

			SEC File No. 333-235977

			Filed January 21, 2020

Ladies and Gentlemen:

Pursuant to Rule 461 under the Securities Act of 1933, as amended, Windtree Therapeutics, Inc. (the “Company”) hereby requests that the effective date of the Company’s Registration Statement on Form S-1 (File No. 333-235977) (the “Registration Statement”) be accelerated so that the Company’s Registration Statement will become effective at 4:00 PM, eastern time, on January 29, 2020, or as soon thereafter as is practicable.

Please feel free to direct any questions or comments concerning this request to Rachael Bushey, Esq. of Pepper Hamilton LLP at (215) 981-4331.

The Company understands that the staff of the United States Securities and Exchange Commission will consider this request as confirmation by the Company that it is aware of its responsibilities under the federal securities laws as they relate to the issuance of the securities covered by the Registration Statement.

			WINDTREE THERAPEUTICS, INC.

			By:

			/s/ Craig E. Fraser

			Name: Craig E. Fraser

			Title: President, Chief Executive Officer

Cc: Rachael Bushey, Pepper Hamilton LLP

Windtree Therapeutics, Inc. – Acceleration Letter

January 27, 2020
Craig E. Fraser
President and Chief Executive Officer
Windtree Therapeutics, Inc.
2600 Kelly Road, Suite 100
Warrington, PA 18976
Re:Windtree Therapeutics, Inc.
Registration Statement on Form S-1
Filed January 21, 2020
File No. 333-235977
Dear Mr. Fraser:
            This is to advise you that we have not reviewed and will not review your registration
statement.
            Please refer to Rules 460 and 461 regarding requests for acceleration.  We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
            Please contact Jeffrey Gabor at 202-551-2544 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Rachael M. Bushey, Esq.

July 18, 2019
Craig E. Fraser
President and Chief Executive Officer
Windtree Therapeutics, Inc.
2600 Kelly Road, Suite 100
Warrington, Pennsylvania 18976-3622
Re:Windtree Therapeutics, Inc.
Preliminary Information Statement on Schedule 14C
Filed June 24, 2019
File No. 000-26422
Dear Mr. Fraser:
            We have completed our review of your filing.  We remind you that the company and its
management are responsible for the accuracy and adequacy of their disclosures, notwithstanding
any review, comments, action or absence of action by the staff.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc:       Brian Lee - Dentons US LLP

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Windtree Therapeutics, Inc.

2600 Kelly Road, Suite 100

Warrington, Pennsylvania 18976-3622

VIA EDGAR

July 17, 2019

Division of Corporation Finance

Office of Healthcare & Insurance

United States Securities and Exchange Commission

100 F Street, N.E.

Washington, D.C. 20549

			Re:

			Windtree Therapeutics, Inc. (the “Company”)

			Preliminary Information Statement on Schedule 14C

			Filed June 24, 2019

			File No. 000-26422

We refer to the July 3, 2019 comment letter of the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) on the Company’s Preliminary Information Statement on Schedule 14C filed on June 24, 2019 (the “Information Statement”). This letter sets forth the Company’s response to the Staff’s comment. For your convenience, we have reproduced below in italics the Staff’s comment and have provided the Company’s response immediately below.

Comment: As you are not currently listed on Nasdaq, and as you do not disclose the terms of a specific transaction, please expand your disclosure regarding the share issuance proposal to discuss the parameters of the advance authorization to issue securities, including whether and when the consent expires.

Response: After further consideration, we have removed the share issuance proposal from the Information Statement. A revised Preliminary Information Statement on Schedule 14C has been filed on EDGAR contemporaneously with the filing of this letter.

If you have any questions, please do not hesitate to contact the undersigned at (215) 488-9347 or Brian Lee at our counsel, Dentons US LLP, at (212) 768-6926.

Sincerely,

/s/ Mary B. Templeton

Mary B. Templeton

Senior Vice President, General Counsel and

Corporate Secretary

July 3, 2019
Craig E. Fraser
President and Chief Executive Officer
Windtree Therapeutics, Inc.
2600 Kelly Road, Suite 100
Warrington, Pennsylvania 18976-3622
Re:Windtree Therapeutics, Inc.
Preliminary Information Statement on Schedule 14C
Filed June 24, 2019
File No. 000-26422
Dear Mr. Fraser:
            We have reviewed your filing and have the following comment.
            Please respond to this comment within ten business days by providing the requested
information or advise us as soon as possible when you will respond.  If you do not believe our
comment applies to your facts and circumstances, please tell us why in your response.
            After reviewing your response to this comment, we may have additional comments.
Preliminary Information Statement on Schedule 14C filed June 24, 2019
The Share Issuance Proposal, page 9
1.As you are not currently listed on Nasdaq, and as you do not disclose the terms of a
specific transaction, please expand your disclosure regarding the share issuance proposal
to discuss the parameters of the advance authorization to issue securities, including
whether and when the consent expires.
            We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.

 FirstName LastNameCraig E. Fraser
 Comapany NameWindtree Therapeutics, Inc.
 July 3, 2019 Page 2
 FirstName LastName
Craig E. Fraser
Windtree Therapeutics, Inc.
July 3, 2019
Page 2
            Please contact Irene Paik at 202-551-6553 or Mary Beth Breslin at 202-551-3625 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc:       Brian Lee - Dentons US LLP

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May 15, 2019

VIA EDGAR

U.S. Securities and Exchange Commission

Division of Corporation Finance

100 F Street, N.E.

Washington, D.C. 20549-0405

Re: Windtree Therapeutics, Inc.

Registration Statement on Form S-1

File No. 333-231128

Ladies and Gentlemen:

Pursuant to Rules 460 and 461 of the General Rules and Regulations under the Securities Act of 1933, as amended, Windtree Therapeutics, Inc. (the “Company”) hereby requests the Securities and Exchange Commission (the “Commission”) to accelerate the effective date of the above-referenced Registration Statement and declare such Registration Statement effective as of 4:30 p.m. Eastern Time, on Wednesday, May 15, 2019, or at such later time as the Company or its counsel, Dentons US LLP, may orally request via telephone call to the staff (the “Staff”) of the Commission. The Company also requests that the Commission specifically confirm such effective date and time to the Company.

If you have any further comments or require any further information or if any questions should arise in connection with this submission, please call Ms. Mary Templeton at (215) 488-9347 or Mr. Brian Lee at (212) 768-6926 at Dentons US, LLP.

			Very truly yours,

			/s/ John Tattory

			John Tattory

			Chief Financial Officer

May 7, 2019
Craig Fraser
Chief Executive Officer
Windtree Therapeutics, Inc.
2600 Kelly Road, Suite 100
Warrington, PA18976
Re:Windtree Therapeutics, Inc.
Registration Statement on Form S-1
Filed April 30, 2019
File No. 333-231128
Dear Mr. Fraser:
            This is to advise you that we have not reviewed and will not review your registration
statement.
            Please refer to Rules 460 and 461 regarding requests for acceleration.  We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
            Please contact Tonya K. Aldave at (202) 551-3601 with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc:       Nathan J. Hyman, Esq.

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WINDTREE THERAPEUTICS, INC.

2600 Kelly Road, Suite 100

Warrington, Pennsylvania 18976

P - 215.488.9300

F - 215.488.9557

www.windtreetx.com

April 12, 2017

Suzanne Hayes

Assistant Director

Office of Healthcare and Insurance

Division of Corporation Finance

U.S. Securities and Exchange Commission

100 F Street, NE

Washington, D.C. 20549

			Re:        Windtree Therapeutics, Inc.

			Registration Statement on Form S-1

			File No. 333-217161

			Acceleration Request

			Requested Date: April 14, 2017

			Requested Time: 5:00 PM Eastern Time

Ladies and Gentlemen:

Pursuant to Rule 461 of Regulation C promulgated under the Securities Act of 1933, as amended, Windtree Therapeutics, Inc. (the "Company"), a Delaware corporation, hereby requests that the effectiveness of the Company’s Registration Statement on Form S-1, File No. 333-217161, be accelerated to the date and time set forth above, or as soon thereafter as is practicable.

Very truly yours,

WINDTREE THERAPEUTICS, INC.

			/s/ Mary B. Templeton

			Mary B. Templeton

			Senior Vice President, General Counsel and Corporate Secretary

cc:      Ira L. Kotel, Dentons US LLP

Mail Stop 4546
April 11 , 2017

Craig E. Fraser
Chief Executive Officer
Windtree Therapeutics , Inc.
2600 Kelly Road, Suite 100
Warrington, PA  18976

Re: Windtree Therapeutics , Inc.
  Registration Statement on Form S-1
Filed  April 5 , 2017
  File No.  333-217161

Dear Mr. Fraser :

This is to advise you that we have not  reviewed and will not review your registration
statement .

Please refer to Rules 460 and 461 regarding requests for acceleration.  We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.

Please  contact Ada D. Sarmento at (202) 551 -3798  with any questions.

Sincerely,

 /s/ Mary Beth Breslin for

Suzanne Hayes
Assistant Director
Office of Healthcare and Insurance

cc:  Brian Lee
 Dentons US LLP

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DISCOVERY LABORATORIES, INC.

2600 Kelly Rd, Suite 100

Warrington, PA 18976

P - 215.488.9443

F - 215.488.9557

www.discoverylabs.com

February 10, 2014

Christina M. De Rosa

Division of Corporation Finance

United States Securities and Exchange Commission

100 F Street, NE

Washington, D.C. 20549

Re:

Discovery Laboratories, Inc.

Registration Statement on Form S-3

Filed January 22, 2014 (File No. 333-193490)

Dear Ms. De Rosa:

Pursuant to Rule 461 of Regulation C promulgated under the Securities Act of 1933, Discovery Laboratories, Inc., a Delaware corporation (the “Company”), hereby requests that the effectiveness of the Company’s Registration Statement on Form S-3, File No. 333-193490, be accelerated to 4:30 p.m. (New York time), February 12, 2014, or as soon thereafter as is practicable.

In connection with this letter, the Company acknowledges that:

•            should the Securities and Exchange Commission (the “Commission”) or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing;

•            the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and

•            the Company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.

Very truly yours,

DISCOVERY LABORATORIES, INC.

/s/ Mary B. Templeton

Mary B. Templeton

Senior Vice President, General Counsel and Corporate Secretary

Cc: Ira L. Kotel

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DISCOVERY LABORATORIES, INC.

2600 Kelly Rd, Suite 100

Warrington, PA 18976

P - 215.488.9443

F - 215.488.9557

www.discoverylabs.com

February 10, 2014

Christina M. De Rosa

Division of Corporation Finance

United States Securities and Exchange Commission

100 F Street, NE

Washington, D.C. 20549

Re:

Discovery Laboratories, Inc.

Registration Statement on Form S-3

Filed January 22, 2014 (File No. 333-193490)

Dear Ms. De Rosa:

Pursuant to Rule 461 of Regulation C promulgated under the Securities Act of 1933, Discovery Laboratories, Inc., a Delaware corporation (the “Company”), hereby requests that the effectiveness of the Company’s Registration Statement on Form S-3, File No. 333-193490, be accelerated to 4:30 p.m. (New York time), February 12, 2014, or as soon thereafter as is practicable.

Very truly yours,

DISCOVERY LABORATORIES, INC.

/s/ Mary B. Templeton

Mary B. Templeton

Senior Vice President, General Counsel and Corporate Secretary

Cc: Ira L. Kotel

January 3 1, 2014

Via E -mail
Mary B. Templeton , Esq.
Senior Vice President, General Counsel and Corporate Secretary
Discovery Laboratories , Inc.
2600 Kelly Road , Suite 100
Warrington, PA 18976

Re: Discovery Laboratories, Inc.
  Registration Statement on Form S-3
Filed  January 22, 2014
  File No.  333-193490

Dear Ms. Templeton :

We have limited our review of your  registration statement to those issues  we hav e
addressed in our comment .

Please respond to this letter by amending your registration statement and providing the
requested information .  Where  you do not believe our comment applies  to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why  in your
response.

After reviewing any amendment to your registration statement and the information you
provide in response to this comment , we may have  additional comments.

1. We are currently processing your  pending request for confidential treatment.   Please be
advised that we will not be in a position to declare this registration statement effective
until we resolve all issues concerning the confidential treatment request.

We urge all persons who are responsible for the accuracy and adequacy of the  disclosure
in the filing to be certain that the filing includes the information the Securities Act of 193 3 and
all applicable Securities  Act rules require.   Since the company and its management are in
possession of all facts relating to a company’s disclo sure, they are responsible for the accuracy
and adequacy of the disclosures they have made.

Notwithstanding our comment , in the event you request acceleration of the effective date
of the pending registration statement please provide a written statement  from the company
acknowledging that:

Mary B. Templeton, Esq.
Discovery Laboratories , Inc.
January 3 1, 2014
Page 2

  should the Commission or the staff, acting pursuant to delegated authority, declare the
filing effective, it does not foreclose the Commission from taking any action with respect
to the filing;

 the action of the Com mission or the staff, acting pursuant to delegated authority, in
declaring the filing effective, does not relieve the company from its full responsibility for
the adequacy and accuracy of the disclosure in the filing; and

 the company may not assert staff  comments and the declaration of effectiveness as a
defense in any proceeding initiated by the Commission or any person under the federal
securities laws of the United States.

Please refer to Rules 460 and 461 regarding requests for  acceleration .  We will  consider a
written request for acceleration of the effective date of the registration statement as confirmation
of the fact that those requesting acceleration are aware of their respective responsibilities under
the Securities Act of 1933 and the Securiti es Exchange Act of 1934 as they relate to the proposed
public offering of the securities specified in the above registration statement.  Please allow
adequate time  for us to review any amendment prior to the requested effective date of the
registration sta tement.

Please contact Christina De Rosa  at (202) 551 -3577  or me at (202) 551 -3715  with any
other questions.

Sincerely,

 /s/ Daniel Greenspan for

Jeffrey P. Riedler
Assistant Director
cc: Via E -mail
 Ira L. Kotel, Esq.
 Dentons US LLP
 1221 Avenue of the Americas
 New York, NY 10020

CORRESP
1
filename1.htm

DISCOVERY LABORATORIES, INC.

2600 Kelly Rd, Suite 100

Warrington, PA 18976

P - 215.488.9300

F - 215.488.9557

www.discoverylabs.com

June 19, 2013

Jeffrey Riedler, Assistant Director

Division of Corporation Finance

United States Securities and Exchange Commission

100 F Street, NE

Washington, D.C. 20549

Re:               Discovery Laboratories, Inc.

Registration Statement on Form S-3

Filed April 15, 2013 (File No. 333-187934)

Dear Mr. Riedler:

Pursuant to Rule 461 of Regulation C promulgated under the Securities Act of 1933, Discovery Laboratories, Inc., a Delaware corporation (the “Company”), hereby requests that the effectiveness of the Company’s Registration Statement on Form S-3, File No. 333-187934, be accelerated to 4:30 p.m. (New York time), June 20, 2013, or as soon thereafter as is practicable.

Very truly yours,

DISCOVERY LABORATORIES, INC.

/s/ Mary B. Templeton

Mary B. Templeton

Senior Vice President, General Counsel and

Corporate Secretary

Cc: Ira L. Kotel

CORRESP
1
filename1.htm

Discovery Laboratories, Inc.

200 Kelly Road, Suite 100

Warrington, PA 18976-3622

CONFIDENTIAL

VIA EDGAR

June 14, 2013

Jeffrey P. Riedler

Assistant Director

Division of Corporation Finance

United States Securities and Exchange Commission

100 F Street, N.E.

Washington, D.C. 20549

Re:
Discovery Laboratories, Inc.

Registration Statement on Form S-3

Filed April 15, 2013

File No. 333-187934

Dear Mr. Riedler:

By letter dated April 24, 2013 (the “SEC Letter”), the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) provided comments on the Registration Statement on Form S-3 (the “Registration Statement”) filed by Discovery Laboratories, Inc. (the “Company”) on April 15, 2013,

In order to facilitate your review, this letter responds to each of the comments set forth in the SEC Letter on a point-by-point basis. The numbered paragraphs set forth below respond to the Staff’s comments and correspond to the numbered paragraphs in the SEC Letter.

Form S-3

General

1.
We note that you filed a request for confidential treatment on March 18, 2013. Please note that we will not be in a position to accelerate the effectiveness of your registration statement until we have resolved all outstanding issues on your confidential treatment request.

The Company has submitted a revised confidential treatment request (the “Revised Request”) to the Staff and has received oral confirmation that the Staff has no further comments on the Company’s revised confidential treatment request. A current report on Form 8-K/A was filed on June 14, 2013 to refile the relevant exhibits with revised redactions that conformed to the Revised Request.

Information Incorporated by Reference, page 19

2.
We note that your registration statement incorporates by reference your annual report on Form 10-K for the year ended December 31, 2012. This filing does not contain the Part III information that is required by Form 10-K. Please amend your Form S-3 filing, amend your Form 10-K filing, or file your proxy statement to include the required Part III information. Your filing must be complete before we take final action on the registration statement.

On April 30, 2013 the Company filed its definitive proxy statement, which included the required Part III information.

*            *            *

The Company acknowledges that:

·
should the Commission or the Staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing;

·
the action of the Commission of the Staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and

·
the Company may not assert Staff comments and the declaration of effectiveness as a defense in any proceedings initiated by the Commission or any person under the federal securities laws of the United States.

If you have any questions, or if we may be of any assistance, please do not hesitate to contact the undersigned at (215) 488-9347 or Ira L. Kotel at our counsel, Dentons US LLP, at (973) 912-7177.

Sincerely,

/s/ Mary B. Templeton

Mary B. Templeton

Senior Vice President, General Counsel

and Corporate Secretary

cc: Ira L. Kotel

April 24, 2013

Via E -mail
Ms. Mary Templeton
Senior Vice President, General Counsel and Corporate Secretary
Discovery Laboratories, Inc.
2600 Kelly Road, Suite 100
Warrington, Pennsylvania 18976 -3622

Re: Discovery Laboratories, Inc.
  Registration Statement on Form S-3
Filed  April 15, 2013
  File No.  333-187934

Dear Ms. Templeton :

We have limited our review of your registration statement to those issues we have
addressed in our comments.  In  some of our comments, we may ask you to provide us with
information so we may better understand your disclosure.

Please respond to this letter by amending your registration statement and providing the
requested information .  Where you do  not believe our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.

After reviewing any amendment to your registration statement and the information you
provide in response to these  comments, we may have  additional comments.

Form S -3

General

1. We note that you filed a request for confidential treatment on March 18, 2013.  Please
note that we will not be in a position to accelerate the effectiveness of your registration
statement until we have resolved all outstanding issues on your confidential treatment
request.

Information Incorporated by Reference, page 19

2. We note that your registration statement incorporates by reference your annual report on
Form 10 -K for the year en ded December 31, 2012.   This filing does not contain the Part
III information that is required by Form 10 -K.  Please amend your Form S -3 filing,
amend your Form 10 -K filing, or file your proxy statement to include the required Part III

Mary Templeton
Discovery Laboratories, Inc.
April 24, 2013
Page 2

 information.   Your f iling must be complete before we take final action on the registration
statement.

We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filing to be certain that the filing includes the information the Securities A ct of 193 3 and
all applicable Securities  Act rules require.   Since the company and its management are in
possession of all facts relating to a company’s disclosure, they are responsible for the accuracy
and adequacy of the disclosures they have made.

Notwithstanding our comments, in the event you request acceleration of the effective date
of the pending registration statement please provide a written statement from the company
acknowledging that:

 should the Commission or the staff, acting pursuant to delegated authority, declare the
filing effective, it does not foreclose the Commission from taking any action with respect
to the filing;

 the action of the Commission or the staff, acting pursuant to delegated authority, in
declaring the filing effective, does not relieve the company from its full responsibility for
the adequacy and accuracy of the disclosure in the filing; and

 the company  may not assert staff comments and the declaration of effectiveness as a
defense in any proceeding initiated by the Commission or any person under the federal
securities laws of the United States.

Please refer to Rules 460 and 461 regarding requests for  acceleration .  We will consider a
written request for acceleration of the effective date of the registration statement as confirmation
of the fact that those requesting acceleration are aware of their respective responsibilities under
the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed
public offering of the securities specified in the above registration statement.  Please allow
adequate time  for us to review any amendment prior to the requested effective date of  the
registration statement.

Please contact Matthew Jones  at (202) 551 -3786  or me at (202) 551 -3715  with any other
questions.

Sincerely,

 /s/ Jeffrey P. Riedler

 Jeffrey P. Riedler
Assistant Director

Mary Templeton
Discovery Laboratories, Inc.
April 24, 2013
Page 3

cc:  Ira L. Kotel
       Dentons US LLP
       1221 Avenue of the Americas
      New York, New York 10020

November 15, 2010
 Mr. John G. Cooper Executive Vice President and Chief Financial Officer
Discovery Laboratories, Inc. 2600 Kelly Road, Suite 100    Warrington, Pennsylvania 18976
 Re: Discovery Laboratories, Inc .
  Form 10-K for the Year Ended December 31, 2009
Form 10-K/A for the Year Ended December 31, 2009
Forms 10-Q for the Quarterly Period s Ended March 31 and June 30, 2010
 File No. 000-26422

Dear Mr. Cooper:

We have completed our review of your fili ngs and do not have any further comments at
this time.
Sincerely,

        G u s  R o d r i g u e z
Accounting Branch Chief

CORRESP
1
filename1.htm

    Unassociated Document

        Discovery
Laboratories, Inc.

         200
Kelly Road, Suite 100

        Warrington,
PA  18976-3622

        CONFIDENTIAL

        VIA
EDGAR

        November
12, 2010

        Jim B.
Rosenberg

        Division
of Corporation Finance

        United
States Securities and Exchange Commission

        100 F
Street, N.E.

        Washington,
D.C. 20549

                  Re:

                  Discovery
      Laboratories, Inc. (the “Company”)

                  Form
      10-K for the Year Ended December 31, 2009 (“2009 10-K”)

                  Form
      10-K/A for the Year Ended December 31, 2009

                  Forms
      10-Q for the Quarterly Periods Ended March 31 and June 30,
      2010

                  File
      No. 000-26422

        Dear Mr.
Rosenberg:

        We refer
to the following:

        (a) the
September 17, 2010 comment letter of the staff (the “Staff”) of the Securities
and Exchange Commission (the “Commission”) on the Company’s Annual Report on
Form 10-K for the Year Ended December 31, 2009, the amendment to such Annual
Report on Form 10-K/A and the Quarterly Reports on Form 10-Q for the Quarterly
Periods Ended March 31 and June 30, 2010, and to the Company’s responses thereto
of October 1, 2010;

        (b) a
telephone call on November 5, 2010 between Messrs. Ira Kotel and Roland Chase of
our counsel, SNR Denton US LLP, and Ms. Ibolya Ignat of the Staff, in which Ms.
Ignat conveyed additional comments on behalf of the Staff;

        (c) our
response dated November 8, 2010 to such comments (the “November 8 Response”),
which was filed as correspondence on EDGAR;

        (d) a
telephone call on November 9, 2010 between Mr. Kotel and Mr. Marc Brunhofer of
the Staff, in which Mr. Brunhofer relayed preliminary feedback on the November 8
Response;

        (e) our
response dated November 10, 2010 to such feedback (the “November 10 Response”),
which was filed as correspondence on EDGAR; and

         (f) a
telephone call on November 10, 2010 between the undersigned and John Tattory of
the Company, in which Ms. Ignat relayed additional feedback on the November 10
Response.

          Securities
and Exchange Commission

          November
12, 2010

          Page
2

        As discussed in the conversations with
the Staff yesterday and today, and in order to assist the Staff in its review,
we are enclosing :

                  i.

                  as
      Appendix
      A hereto a draft of Amendment No. 2 to our Annual Report on Form
      10-K for the Year Ended December 31,
2009;

                  ii.

                  as
      Appendix
      B hereto a draft of Amendment No. 1 to our Quarterly Report on Form
      10-Q for the Quarterly Period Ended March 31, 2010;
  and

                  iii.

                  as
      Appendix
      C hereto a draft of Amendment No. 1 to our Quarterly Report on Form
      10-Q for the Quarterly Period Ended June 30,
  2010.

        The
Company proposes to file each of the documents referred to in (i), (ii), and
(iii) above, which include the financial statement impact of the change in
accounting treatment to reflect the reclassification of the affected warrants
from equity to  liability in an amount equal to the fair value of the
warrants, as of the dates of issuance, calculated using the Black Scholes option
pricing model.   The restatement will not have an impact on any
other amounts previously reported, including Assets; Revenues; Research and
Development Expenses and other operating expenses; Cash Flows; Loans, Equipment
Loan and Accounts Payables; and Contractual Obligations.

        Finally, we confirm that the Company
has reviewed ASC 815-40-25-16 and concluded that it does not apply to the
affected warrants.

        If you
have any questions, or if we may be of any assistance, please do not hesitate to
contact the undersigned at (415) 488-9347 or Ira Kotel or Roland Chase at our
counsel, SNR Denton US LLP, at (973) 912-7100.

                    Sincerely,

                    /s/ Mary
      B. Templeton

                    Mary
      B. Templeton

                    Senior
      Vice President and

                    Deputy
      General Counsel

          Securities
and Exchange Commission

          November
12, 2010

          Page
3

        Copy
to:

        Ibolya
Ignat, Staff Accountant

        Marc
Brunhofer, Accounting Reviewer

        Jennifer
C. Riegel,  Staff Attorney

        Division
of Corporation Finance

        United
States Securities and Exchange Commission

        100 F
Street, N.E.

        Washington,
D.C. 20549

        John C.
Cooper

        David L.
Lopez

        Discovery
Laboratories, Inc.

        200 Kelly
Red, Suite 100

        Warrington,
PA  18976-3622

        Ira L.
Kotel

        SNR
Denton US LLP

        Two World
Financial Center

        New York,
NY 10281-1008

        Roland S.
Chase

        SNR
Denton US LLP

        101 JFK
Parkway

        4th
Floor

        Short
Hills, NJ 07078-2708

      Appendix A

      DRAFT - FOR DISCUSSION PURPOSES
ONLY

      UNITED
STATES

    SECURITIES
AND EXCHANGE COMMISSION

    WASHINGTON,
D.C.  20549

    FORM
10-K/A

    (Amendment
No. 2)

              x

              ANNUAL REPORT PURSUANT TO
      SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
      1934

    For the
fiscal year ended December 31, 2009

    or

              ¨

              TRANSITION REPORT PURSUANT TO
      SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
      1934

    For the
transition period from
    to

    Commission
file number 000-26422

    DISCOVERY
LABORATORIES, INC.

    (Exact
name of registrant as specified in its charter)

                Delaware

                94-3171943

                (State
      or other jurisdiction of

                incorporation
      or organization)

                (I.R.S.
      Employer

                Identification
      Number)

                2600
      Kelly Road, Suite 100

                Warrington,
      Pennsylvania 18976-3622

                (Address
      of principal executive offices)

    (215)
488-9300

    (Registrant’s
telephone number, including area code)

    Securities
registered pursuant to Section 12(b) of the Act:

                  Title of each class

                  Name of each exchange on which
      registered

                  Common
      Stock, $0.001 par value

                  The
      Nasdaq Capital Market

                  Preferred
      Stock Purchase Rights

    Securities
registered pursuant to Section 12(g) of the Act:

    None

    __________________

    Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in
Rule 405 of the Securities Act.  YES  ¨
  NO  x

    Indicate
by check mark if the registrant is not required to file reports pursuant to
Section 13 or Section 15(d) of the Exchange Act.  YES  ¨
  NO  x

    Indicate
by check mark whether the registrant: (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to such filing requirements for
the past 90 days.   YES  x
  NO  ¨

    Indicate
by check mark whether the registrant has submitted electronically and posted on
its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this
chapter) during the preceding 12 months (or for such shorter period that the
registrant was required to submit and post such files).  YES  ¨
  NO  ¨

    Indicate
by check mark if disclosure of delinquent filers pursuant to Item 405 of
Regulation S-K (§229.405 of this chapter) is not contained herein, and will not
be contained, to the best of the registrant’s knowledge, in definitive proxy or
information statements incorporated by reference in Part III of this Form 10-K/A
or any amendment to this Form 10-K. o

    Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting
company.  See the definitions of “large accelerated filer,” “accelerated
filer” and “smaller reporting company” in Rule 12b-2 of the Exchange
Act.

                Large
      accelerated filer

                ¨

              Accelerated
      filer        x

                Non-accelerated
      filer

                ¨

                Smaller
      reporting company

                x

    Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act).

    YES
¨
  NO  x

    The
aggregate market value of shares of voting and non-voting common equity held by
non-affiliates of the registrant computed using the closing price of common
equity as reported on The Nasdaq Global Market under the symbol DSCO on June 30,
2009, the last business day of the registrant’s most recently completed second
fiscal quarter, was approximately $126 million.  For the purposes of
determining this amount only, the registrant has defined affiliates to include:
(a) the executive officers named in Part III of this Annual Report on Form 10-K;
(b) all directors of the registrant; and (c) each shareholder, if any, that has
informed the registrant by March 1, 2009 that it is the beneficial owner of 10%
or more of the outstanding shares of common stock of the
registrant.

    As of
November 12, 2010, 206,652,815 shares of the registrant’s common stock were
outstanding.

    DOCUMENTS
INCORPORATED BY REFERENCE:

    EXPLANATORY
NOTE

       We are
filing this Amendment No. 2 on Form 10-K/A to our Annual Report on Form 10-K for
the year ended December 31, 2009, which was filed with the Securities and
Exchange Commission (“SEC”) on March 10, 2010 (“Annual Report on Form 10-K”),
(i) to amend Item 1A – “Risk Factors” to add to the risk factors previously
provided in our Annual Report on Form 10-K additional risk factors related to
the restatement of our financial statements, (ii) to amend Item 6 – “Selected
Financial Data” and Item 8 – “Financial Statements and Supplementary Data” to
restate our audited financial statements for the year ended December 31, 2009 to
reflect the reclassification of certain warrants from equity to liabilities, as
discussed below, (iii) to make corresponding amendments to Item 7 –
“Management’s Discussion and Analysis of Financial Condition and Results of
Operations” (“MD&A”) and to provide in MD&A additional disclosure with
respect to research and development expenses, (iv) to amend Item 9A – “Controls
and Procedures” to reflect a reassessment of  our disclosure controls
and procedures, and internal control over financial reporting, as of December
31, 2009 in light of the restatement of our audited financial statements for the
year ended December 31, 2009.

    Other
than the foregoing, and the new certifications required by Rule 13a-14(a) under
the Securities and Exchange Act of 1934 (“Exchange Act”), our Annual Report
on Form 10-K is not being amended or updated in any respect.  This
Amendment No. 2 continues to describe the conditions as of the date of the
Annual Report on Form 10-K, and, except as contained herein, we have not
modified or updated the disclosures contained in the Annual Report on Form
10-K.  This Amendment No. 2 should be read in conjunction with our
filings made with the SEC subsequent to the filing of the Annual Report on Form
10-K, including any amendment to those filings.

    Restatement
of Financial Statements

    In
connection with a review of our Annual Report on Form 10-K among the Audit
Committee of our Board of Directors (the “Audit Committee”), and our management,
with the assistance of  Ernst & Young LLP (“Ernst & Young”), our
independent registered public accounting firm, and our outside legal advisors,
the Audit Committee has reassessed the accounting classification of certain
warrants that we
issued in May 2009 with respect to ASC 815 “Derivatives and Hedging — Contracts
in Entity’s Own Equity” (“ASC 815,” formerly known as Emerging Issues Task Force
Issue 00-19, “Accounting for Derivative Financial Instruments Indexed to, and
Potentially Settled in, a Company’s Own Stock”).  The review was conducted
to respond to certain comments raised by the Staff of the SEC following its
periodic review of our Annual Report on Form 10-K.

    We have
historically accounted for warrants, which prior to May 2009 were issued in
private transactions, as equity instruments.  Our warrants generally
provide that, in the event the related registration statement or an exemption
from registration is not available for the issuance or resale of the warrant
shares, the holder  may exercise the warrant on a cashless basis.
 However, notwithstanding the availability of cashless exercise and without
any evaluation of remoteness or probability, ASC 815, as interpreted,
establishes a presumption that, in the absence of express language to the
contrary, registered warrants may be subject to net cash settlement, as it is
not within our absolute control to provide freely-tradable shares in all
circumstances.

       After
extensive discussion, the Audit Committee, together with our management and in
consultation with Ernst & Young and our outside legal advisors, determined
that, notwithstanding the highly–remote and theoretical possibility of net cash
settlement, the warrants identified above should have been recorded as
liabilities, measured at fair value calculated using the Black Scholes option
pricing model on the date of issue, with changes in the fair values recognized
in our quarterly statement of operations in our quarterly financial
reports.  Accordingly, the Audit Committee also concluded on
November 8, 2010 that our previously-filed consolidated financial statements for
the year ended December 31, 2009 on Form 10-K; Ernst & Young’s reports on
the financial statements and the effectiveness of internal control over
financial reporting for the year ended December 31, 2009; each of the
consolidated financial statements included in our Quarterly Reports on Form 10-Q
for the periods ended June 30, 2009 and September 30, 2009; and all related
earnings releases and similar communications that we issued with respect to the
foregoing, should no longer be relied upon. As
a result, we are restating our previously-filed consolidated financial
statements for the year ended December 31, 2009 on Form 10-K.  We do
not plan to amend our consolidated financial statements included in our
Quarterly Reports on Form 10-Q for the periods ended June 30, 2009 and September
30, 2009.

        ii

    The
restatements will have no impact on amounts previously reported for Assets;
Revenues; Operating Expenses; Cash Flows; Loans, Equipment Loan and Accounts
Payables; and Contractual Obligations.  The restatements will have no
effect on our development programs, including Surfaxin®, anticipated development
milestones, business strategy or operations. See, Item
7 – “Management’s Discussion and Analysis of Financial Condition and Results of
Operations,” in this Amendment No. 2.

       In
light of the restatement, we have also determined that as of December 31, 2009
our disclosure controls and procedures were not effective, and that we did not
maintain effective internal control over financial reporting due to a
material weakness related to the initial classification and subsequent
accounting of registered warrants as either liabilities or equity
instruments.  See, “Item 9A - Controls and
Procedures.”

    Unless
the context otherwise requires, all references to “we,” “us,” “our,” and the
“Company” include Discovery Laboratories, Inc., and its wholly-owned, presently
inactive subsidiary, Acute Therapeutics, Inc.

    FORWARD-LOOKING
STATEMENTS

    This
Am

CORRESP
1
filename1.htm

    Unassociated Document

    Discovery
Laboratories, Inc.

    200 Kelly
Red, Suite 100

    Warrington,
PA  18976-3622

    CONFIDENTIAL

    VIA
EDGAR

    November
10, 2010

    Jim B.
Rosenberg

    Division
of Corporation Finance

    United
States Securities and Exchange Commission

    100 F
Street, N.E.

    Washington,
D.C. 20549

    Re:         Discovery
Laboratories, Inc. (the “Company”)

    Form 10-K
for the Year Ended December 31, 2009 (“2009 10-K”)

    Form
10-K/A for the Year Ended December 31, 2009

    Forms
10-Q for the Quarterly Periods Ended March 31 and June 30, 2010

    File No.
000-26422

    Dear Mr.
Rosenberg:

    We refer
to the following:

    (a) the
September 17, 2010 comment letter of the staff (the “Staff”) of the Securities
and Exchange Commission (the “Commission”) on the Company’s Annual Report on
Form 10-K for the Year Ended December 31, 2009, the amendment to such Annual
Report on Form 10-K/A and the Quarterly Reports on Form 10-Q for the Quarterly
Periods Ended March 31 and June 30, 2010, and to the Company’s responses thereto
of October 1, 2010;

    (b) a
telephone call on November 5, 2010 between Messrs. Ira Kotel and Roland Chase of
our counsel, SNR Denton US LLP, and Ms. Ibolya Ignat of the Staff, in which Ms.
Ignat conveyed additional comments on behalf of the Staff;

    (c) our
response dated November 8, 2010 to such comments (the “November 8 Response”),
which was filed as correspondence on EDGAR; and

    (d) a
telephone call on November 9, 2010 between Mr. Kotel and Mr. Marc Brunhofer of
the Staff, in which Mr. Brunhofer relayed preliminary feedback on the November 8
Response.

    Securities
and Exchange Commission

    November
10, 2010

    Page
2

    As discussed in the conversations with
the Staff yesterday and today, and in order to assist the Staff in its review,
we are enclosing as Appendix A hereto a
draft of Amendment No. 2 to our Annual Report on Form 10-K for the Year Ended
December 31, 2009 and as Appendix B hereto a
draft of Amendment No. 1 to our Quarterly Report on Form 10-Q for the Quarterly
Period Ended March 31, 2010, both which the Company proposes to file and which
includes the financial statement impact of the change in accounting treatment to
reflect the reclassification of the affected warrants from equity to liability
in an amount equal to the fair value of the warrants, as of the dates of
issuance, calculated using the Black Scholes option pricing model. The
restatement will not have an impact on any other amounts previously reported,
including Assets; Revenues; Research and Development Expenses and other
operating expenses; Cash Flows; Loans, Equipment Loan and Accounts Payables; and
Contractual Obligations. It is our intention to provide draft disclosure with
respect to Amendment No. 1 to our Quarterly Report on Form 10-Q for the
Quarterly Period Ended June 30, 2010 as soon as possible this week.

    If you
have any questions, or if we may be of any assistance, please do not hesitate to
contact the undersigned at (415) 488-9347 or Ira Kotel or Roland Chase at our
counsel, SNR Denton US LLP, at (973) 912-7100.

                  Sincerely,

                  /s/ Mary B. Templeton

                  Mary
      B. Templeton

                  Senior
      Vice President and

                  Deputy
      General Counsel

    Copy
to:

    Ibolya
Ignat, Staff Accountant

    Marc
Brunhofer, Accounting Reviewer

    Jennifer
C. Riegel,  Staff Attorney

    Division
of Corporation Finance

    United
States Securities and Exchange Commission

    100 F
Street, N.E.

    Washington,
D.C. 20549

    John C.
Cooper

    David L.
Lopez

    Discovery
Laboratories, Inc.

    200 Kelly
Red, Suite 100

    Warrington,
PA  18976-3622

    Ira L.
Kotel

    SNR
Denton US LLP

    Two World
Financial Center

    New York,
NY 10281-1008

    Securities
and Exchange Commission

    November
10, 2010

    Page
3

    Roland S.
Chase

    SNR
Denton US LLP

    101 JFK
Parkway

    4th
Floor

    Short
Hills, NJ 07078-2708

      Appendix
A

      DRAFT -
FOR DISCUSSION PURPOSES ONLY

    UNITED
STATES

    SECURITIES
AND EXCHANGE COMMISSION

    WASHINGTON,
D.C.  20549

    FORM
10-K/A

    (Amendment
No. 2)

              x

              ANNUAL REPORT PURSUANT TO
      SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
      1934

    For the
fiscal year ended December 31, 2009

    or

              ¨

              TRANSITION REPORT PURSUANT TO
      SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
      1934

    For the
transition period from
    to

    Commission
file number 000-26422

    DISCOVERY
LABORATORIES, INC.

    (Exact
name of registrant as specified in its charter)

                Delaware

                94-3171943

                (State
      or other jurisdiction of

                incorporation
      or organization)

                (I.R.S.
      Employer

                Identification
      Number)

                2600
      Kelly Road, Suite 100

                Warrington,
      Pennsylvania 18976-3622

                (Address
      of principal executive offices)

    (215)
488-9300

    (Registrant’s
telephone number, including area code)

    Securities
registered pursuant to Section 12(b) of the Act:

                  Title of each class

                  Name of each exchange on which
      registered

                  Common
      Stock, $0.001 par value

                  The
      Nasdaq Capital Market

                  Preferred
      Stock Purchase Rights

    Securities
registered pursuant to Section 12(g) of the Act:

    None

    __________________

    Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in
Rule 405 of the Securities Act.  YES  ¨
  NO  x

    Indicate
by check mark if the registrant is not required to file reports pursuant to
Section 13 or Section 15(d) of the Exchange Act.  YES  ¨
  NO  x

    Indicate
by check mark whether the registrant: (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to such filing requirements for
the past 90 days.   YES  x
  NO  ¨

    Indicate
by check mark whether the registrant has submitted electronically and posted on
its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this
chapter) during the preceding 12 months (or for such shorter period that the
registrant was required to submit and post such files).  YES  ¨
  NO  ¨

    Indicate
by check mark if disclosure of delinquent filers pursuant to Item 405 of
Regulation S-K (§229.405 of this chapter) is not contained herein, and will not
be contained, to the best of the registrant’s knowledge, in definitive proxy or
information statements incorporated by reference in Part III of this Form 10-K/A
or any amendment to this Form 10-K. o

    Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting
company.  See the definitions of “large accelerated filer,” “accelerated
filer” and “smaller reporting company” in Rule 12b-2 of the Exchange
Act.

                Large
      accelerated filer

                ¨

              Accelerated
      filer        x

                Non-accelerated
      filer

                ¨

                Smaller
      reporting company

                x

    Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act).

    YES
¨
  NO  x

    The
aggregate market value of shares of voting and non-voting common equity held by
non-affiliates of the registrant computed using the closing price of common
equity as reported on The Nasdaq Global Market under the symbol DSCO on June 30,
2009, the last business day of the registrant’s most recently completed second
fiscal quarter, was approximately $126 million.  For the purposes of
determining this amount only, the registrant has defined affiliates to include:
(a) the executive officers named in Part III of this Annual Report on Form 10-K;
(b) all directors of the registrant; and (c) each shareholder, if any, that has
informed the registrant by March 1, 2009 that it is the beneficial owner of 10%
or more of the outstanding shares of common stock of the
registrant.

    As of
November 12, 2010, 206,652,815 shares of the registrant’s common stock were
outstanding.

    DOCUMENTS
INCORPORATED BY REFERENCE:

          DRAFT -
FOR DISCUSSION PURPOSES ONLY

    EXPLANATORY
NOTE

    We are
filing this Amendment No. 2 on Form 10-K/A to our Annual Report on Form 10-K for
the fiscal year ended December 31, 2009, which was filed with the Securities and
Exchange Commission (“SEC”) on March 10, 2010 (“Annual Report on Form 10-K”),
(i) to amend Item 1A – “Risk Factors” to add to the risk factors previously
provided in our Annual Report on Form 10-K additional risk factors related to
the restatement of our financial statements, (ii) to amend Item 6 – “Selected
Financial Data, ” and Item 8 – “Financial Statements and Supplementary Data” to
restate our audited financial statements for the fiscal year ended December 31,
2009 to reflect the reclassification of certain warrants from equity to
liabilities, as discussed below, (iii) to make corresponding amendments to Item
7 – “Management’s Discussion and Analysis of Financial Condition and Results of
Operations” (“MD&A”) and to provide in MD&A additional disclosure with
respect to research and development expenses, (iv) to amend Item 9A – “Controls
and Procedures,” to reflect that the restatement of our audited financial
statements for the fiscal year ended December 31, 2009 resulted from ineffective
disclosure controls and procedures which in turn led to ineffective control over
financial reporting.

    Other
than the foregoing, and the new certifications required by Rule 13a-14(a) under
the Securities and Exchange Act of 1934 (“Exchange Act”), our Annual Report
on Form 10-K is not being amended or updated in any respect.  This
Amendment No. 2 continues to describe the conditions as of the date of the
Annual Report on Form 10-K, and, except as contained herein, we have not
modified or updated the disclosures contained in the Annual Report on Form
10-K.  This Amendment No. 2 should be read in conjunction with our
filings made with the SEC subsequent to the filing of the Annual Report on Form
10-K, including any amendment to those filings.

    Restatement
of Financial Statements

    In
connection with a review of our Annual Report on Form 10-K among the Audit
Committee of our Board of Directors (the “Audit Committee”), and our management,
with the assistance of  Ernst & Young LLP (“Ernst & Young”), our
independent registered public accounting firm, and our outside legal advisors,
the Audit Committee has reassessed the accounting classification of certain
warrants that we
issued in May 2009 with respect to ASC 815 “Derivatives and Hedging — Contracts
in Entity’s Own Equity” (“ASC 815,” formerly known as Emerging Issues Task Force
Issue 00-19, “Accounting for Derivative Financial Instruments Indexed to, and
Potentially Settled in, a Company’s Own Stock”).  The review was conducted
to respond to certain comments raised by the Staff of the SEC following its
periodic review of our Annual Report on Form 10-K.

    We have
historically accounted for warrants, which prior to May 2009 were issued in
private transactions, as equity instruments.  Our warrants generally
provide that, in the event the related registration statement or an exemption
from registration is not available for the issuance or resale of the warrant
shares, the holder  may exercise the warrant on a cashless basis.
 However, notwithstanding the availability of cashless exercise and without
any evaluation of remoteness or probability, ASC 815, as interpreted,
establishes a presumption that, in the absence of express language to the
contrary, registered warrants may be subject to net cash settlement, as it is
not within our absolute control to provide freely-tradable shares in all
circumstances.

    After
extensive discussion, the Audit Committee, together with our management and in
consultation with Ernst & Young and our outside legal advisors, determined
that, notwithstanding the highly–remote and theoretical possibility of net cash
settlement, the warrants identified above should have been recorded as
liabilities, measured at fair value calculated using the Black Scholes option
pricing model on the date of issue, with changes in the fair values recognized
in our quarterly statement of operations in its quarterly financial
reports.  Accordingly, the Audit Committee also concluded on November
8, 2010 that our previously-filed consolidated financial statements for the
fiscal year ended December 31, 2009 on Form 10-K; Ernst & Young’s reports on
the financial statements and the effectiveness of internal control over
financial reporting for the fiscal year ended December 31, 2009; each of the
consolidated financial statements included in our Quarterly Reports on Form 10-Q
for the periods ended June 30, 2009 and September 30, 2009; and all related
earnings releases and similar communications that we issued with respect to the
foregoing, should no longer be relied upon. As
a result, we are restating our previously-filed consolidated financial
statements for the fiscal year ended December 31, 2009 on Form 10-K.  We do
not plan to amend our consolidated financial statements included in our
Quarterly Reports on Form 10-Q for the periods ended June 30, 2009 and September
30, 2009.

        ii

      DRAFT - FOR DISCUSSION PURPOSES ONLY

    The
restatements will have no impact on amounts previously reported for Assets;
Revenues; Operating Expenses; Cash Flows; Loans, Equipment Loan and Accounts
Payables; and Contractual Obligations.  The restatements will have no
effect on our development programs, including Surfaxin®, anticipated development
milestones, business strategy or operations. See, Item
7 – “Management’s Discussion and Analysis of Financial Condition and Results of
Operations,” in this Amendment No. 2.

    We have
also determined that ineffective disclosure controls and procedures that
resulted in the restatement constituted a material weakness in our internal
control over financial reporting. The material weakness related to the initial
classification and subsequent accounting of registered warrants as either
liabilities or equity instruments.  See, “Item 9A - Controls and
Procedures.”

    Unless
the context otherwise requires, all references to “we,” “us,” “our,” and the
“Company” include Discovery Laboratories, Inc., and its wholly-owned, presently
inactive subsidiary, Acute Therapeutics, Inc.

    FORWARD-LOOKING
STATEMENTS

    This
Amendment No. 2 contains “forward-looking statements” within the meaning of
Section 27A of the Securities Act of 1933 (“Securities Act”) and Section 21E of
the Exchange Act.  The forward-looking statements include all matters that
are not historical facts.  Forward-looking statements are only predictions
and provide our current expectations or forecasts of future events and financial
performance and may be identified by the use of forward-looking terminology,
including the terms “believes,” “estimates,” “anticipates,” “expects,” “plans,”
“intends,” “may,” “will” or “should” or, in each case, their negative, or other
variations or comparable terminology, though the absence of these words does not
necessarily mean that a statement is not forward-looking.  We intend that
all forward-looking statements be subject to the safe-harbor provisions of the
Private Securities Litigation Reform Act of 1995.

CORRESP
1
filename1.htm

    Unassociated Document

      Discovery
Laboratories, Inc.

      200 Kelly
Red, Suite 100

      Warrington,
PA  18976-3622

      CONFIDENTIAL

      VIA
EDGAR

      November
8, 2010

      Jim B.
Rosenberg

      Division
of Corporation Finance

      United
States Securities and Exchange Commission

      100 F
Street, N.E.

      Washington,
D.C. 20549

                  Re:

                  Discovery Laboratories, Inc. (the
      “Company”)

        Form 10-K
for the Year Ended December 31, 2009 (“2009 10-K”)

        Form
10-K/A for the Year Ended December 31, 2009

        Forms
10-Q for the Quarterly Periods Ended March 31 and June 30, 2010

        File No.
000-26422

      Dear Mr.
Rosenberg:

      We refer
to the September 17, 2010 comment letter of the staff (the “Staff”) of the
Securities and Exchange Commission (the “Commission”) on the Company’s Annual
Report on Form 10-K for the Year Ended December 31, 2009, the amendment to such
Annual Report on Form 10-K/A and the Quarterly Reports on Form 10-Q for the
Periods Ended March 31 and June 30, 2010, and to the Company’s responses thereto
of October 1, 2010.  By telephone call on November 5, 2010 to Messrs.
Ira Kotel and Roland Chase of our counsel, SNR Denton US LLP, Ms. Ibolya Ignat
conveyed additional comments (“Comments”) on behalf of the
Staff.   This letter sets forth the Company’s responses to the
Comments.  For your convenience, we have reproduced below in italics
each comment and have provided the Company’s response immediately below the
comment.

      Form 10-K for the fiscal
year ended December 31, 2009

      Item
1.  Business

      Business
Operations

      Strategic Alliances and
Collaboration Arrangements

      Laboratorios del Dr. Esteve,
S.A.

      Philip Morris USA Inc. and
Philip Morris Products S.A., page 21

                1.

                We
      refer to our original comment 1. You disclose in your response to our
      prior comment 1 that you will provide additional disclosure in your Form
      10-Q for the fiscal quarter ended September 30, 2010.  We will
      not be in a position to clear the comment until the disclosure has been
      provided.

        Securities
and Exchange Commission

        November
8, 2010

        Page 2

                Response:

      The
Company intends to include the following disclosure in its quarterly report on
Form 10-Q for the quarter ended September 30, 2010 (note, new language is underlined):

      ITEM 1.
BUSINESS – Business Operations.

      Strategic
Alliances and Technology License Agreements

      Laboratorios
del Dr. Esteve, S.A.

      We have a
strategic alliance with Laboratorios del Dr. Esteve, S.A. (Esteve) for the
development, marketing and sales of a broad portfolio of potential KL4
surfactant products in Andorra, Greece, Italy, Portugal, and
Spain.  Esteve will pay us a transfer price on sales of Surfaxin and
other KL4 surfactant products.  We will be responsible for the
manufacture and supply of all of the covered products and Esteve will be
responsible for all sales and marketing in the territory.  Esteve is
obligated to make stipulated cash payments to us of up to $5.1 million in the
aggregate upon our achievement of certain milestones, primarily upon receipt of
marketing regulatory approvals for the covered products.  In addition,
Esteve has agreed to contribute to Phase 3 clinical trials for the covered
products by conducting and funding development performed in the
territory.  As part of a restructuring of this alliance in December
2004, we regained full commercialization rights to our KL4 surfactant technology
in portions of the original territory licensed to Esteve, including key European
markets, Central America, and South America (Former Esteve Territories) and
agreed to pay to Esteve 10% of any cash up-front and milestone fees (not to
exceed $20 million in the aggregate) that we may receive in connection with any
strategic collaborations for the development and/or commercialization of certain
of our KL4 surfactant products, including Surfaxin and Aerosurf  in
the Former Esteve Territories.  The alliance will terminate
as to each covered product, on a country-by-country basis, upon the latest to
occur of: the expiration of last patent claim related to a covered product in
such country; the first commercial sale in such country of the first-to-appear
generic formulation of the covered product, and the tenth anniversary of the
first sale of the covered product in such country.  After all royalty
payment obligations have been satisfied, the license granted under the alliance
agreement becomes fully-paid.  In addition to customary termination
provisions for breach of the agreement by a party, the alliance agreement may be
terminated by Esteve on 60 days’ prior written notice, up to the date of receipt
of the first marketing regulatory approval, or, on up to 6 months’ written
notice, if the first marketing regulatory approval has issued.  We may
terminate the alliance agreement in the event that Esteve acquires a competitive
product (as defined in the agreement).

          Securities
and Exchange Commission

          November
8, 2010

          Page 3

      Johnson
& Johnson, Ortho Pharmaceutical Corporation and The Scripps Research
Institute

      Our
precision-engineered surfactant platform technology, including Surfaxin, is
based on the proprietary synthetic peptide, KL4 (sinapultide), a 21 amino acid
protein-like substance that closely mimics the essential human lung protein
SP-B.  This technology was invented at The Scripps Research Institute
(Scripps) and was exclusively licensed to and further developed by Johnson &
Johnson (J&J).  We have received an exclusive, worldwide license
and sublicense from J&J and its wholly-owned subsidiary, Ortho
Pharmaceutical Corporation, for, and have rights to, a series of over 30 patents
and patent filings (worldwide) which are important, either individually or
collectively, to our strategy for commercializing our precision-engineered
surfactant technology for the diagnosis, prevention and treatment of
disease.  The license and sublicense give us the exclusive rights to
such patents for the life of the patents.  Under the
license agreement, we are obligated to pay licensors fees of up to $2.5 million
in the aggregate upon our achievement of certain milestones, primarily upon
receipt of marketing regulatory approvals for certain designated
products.  In addition, we are required to make royalty payments at
different rates, depending upon type of revenue and country, in amounts of up to
a high single-digit percent of net sales (as defined in the agreement) of
licensed products sold by us or sublicensees, or, if greater, a percentage of
royalty income from sublicensees in the low double digits.  The
license agreement will expire, on a country-by-country, upon expiration of the
last patent containing a valid claim covering a licensed product in such
country.  After payment of all royalty obligations under the license
agreement, the licenses granted thereunder become fully-paid.  In
addition to customary termination provisions for breach of the agreement by a
party, we may terminate the agreement, as to countries other than the U.S. and
Western Europe territories (as defined in the agreement), on a
country-by-country basis, on 6 months’ prior written notice; and as to the
entire agreement, on 60 days’ prior written notice.

      Philip
Morris USA Inc. and Philip Morris Products S.A.

      In March
2008, we restructured our December 2005 strategic alliance with Philip Morris
USA Inc. (PMUSA), d/b/a Chrysalis Technologies (Chrysalis), and assumed full
responsibility from Chrysalis for the further development of the capillary
aerosolization technology, including finalizing design development for the
initial prototype aerosolization device platform and disposable dose
packets.  In connection with the restructuring, we restated our prior
agreement as of March 28, 2008 and entered into an Amended and Restated License
Agreement with PMUSA with respect to the United States (U.S. License Agreement),
and, as PMUSA had assigned to Philip Morris Products S.A. (PMPSA) all rights in
and to the capillary aerosolization technology outside of the United States
(International Rights), effective on the same date, we entered into a License
Agreement with PMPSA with respect to the International Rights (International
License Agreement) on substantially the same terms and conditions as the U.S.
License Agreement.  We currently hold exclusive licenses to the
capillary aerosolization technology both in and outside of the United States for
use with pulmonary surfactants (alone or in combination with any other
pharmaceutical compound(s)) for all respiratory diseases and conditions (the
foregoing uses in each territory, the Exclusive Field).  In addition,
under the U.S. License Agreement, our license to use the capillary
aerosolization technology includes other (non-surfactant) drugs to treat a wide
range of pediatric and adult respiratory indications in hospitals and other
health care institutions.  Each License Agreement,
unless terminated earlier will expire as to each licensed product, on a
country-by-country basis, upon the latest to occur of: the date on which the
sale of such licensed product ceases to be covered by a patent claim of an
issued and unexpired patent in such country; the date a generic form of the
product is introduced in such country; and the tenth anniversary of the tenth
anniversary of the first commercial sale of such licensed product.  In
addition to customary termination provisions for breach of the agreements, we
may terminate the License Agreements, in whole or in part, upon advance written
notice to the licensor. In addition, either party to each License Agreement may
terminate upon a material breach by the other party (subject to a specified cure
period).

          Securities
and Exchange Commission

          November
8, 2010

          Page 4

      As part
of the restructuring, Chrysalis completed a technology transfer, provided
development support to us through June 30, 2008, and also paid us $4.5 million
to support our future development activities.  We are obligated to pay
royalties at a rate equal to a low single-digit percent of sales of products
sold in the Exclusive Field in the territories.  In connection with
exclusive undertakings of PMUSA and PMPSA not to exploit the capillary
aerosolization technology for all licensed uses, we are obligated to pay
royalties on all product sales, including sales of aerosol devices and related
components that are not based on the capillary aerosolization technology;
provided, however, that no royalties are payable to the extent that we exercise
our right to terminate the license with respect to a specific
indication.  We also agreed in the future to pay minimum royalties,
but are entitled to a reduction of future royalties in the amount of any minimum
royalties paid.

      Form 10-Q for the quarterly
period ended June 30, 2010

      Note 4 - Stockholder’s
Equity, page 8

            Securities
and Exchange Commission

            November
8, 2010

            Page 5

                2.

                We
      refer to your response to our original comment 6.  It appears
      that the warrants issued in your May 2009 registered offering and your
      February 2010 public offering do not include explicit language to assure
      that you would not be required in any circumstance to effect a net cash
      settlement of the warrants.  Notwithstanding your assertions
      that you intended, and the holders agreed, that in the event that a
      registration statement was not available, the holders’ only course of
      action would be cashless exercise, the language in Section 1(d) of both
      warrant agreements present the holder with the option to elect cashless
      exercise.  As the agreements merely permit the holders to opt
      for cashless exercise, it appears that the holders may opt to force gross
      settlement in registered shares, and since non-performance is not an
      acceptable alternative under ASC 815-40-25-14, net cash settlement is
      assumed.  Please explain to us how the contractual provisions of
      these warrants support your assertions that the holders agreed to only
      exercise the warrants on a cashless basis if no registration statements
      are available.

      Response:

      We advise you that, after extensive
discussions involving its management, Audit Committee, independent registered
public accounting firm and outside counsel, the Company has determined to change
its accounting treatment with respect to the warrants issued in its May 2009 and
February 2010 registered offerings to record such warrants as liabilities,
measured at fair value on the date of issue, with changes in the fair values
recognized in the Company’s quarterly statement of operations in its quarterly
financial reports.  In connection therewith, the Company intends to
publish a press release and file a current report on Form 8-K on November 9,
2010 under Item 4.02(a) of Form 8-K.  The Company furthermore
anticipates filing, on or before November 15, 2010, an amended Annual Report on
Form 10-K for the fiscal year ended December 31, 2009 and amended Quarterly
Reports on Form 10-Q for the quarterly periods ended March 31, 2010 and June 30,
2010, each with restated financial statements reflecting the reclassification of
the warrants, together with the Quarterly Report on Form 10-Q for the period
ended September 30, 2010.

      In
addition, as discussed in our call this afternoon with Ibolya Ignat, Staff
Accountant, and Marc Brunhofer, Accounting Reviewer, in order to assist the
Staff in its review, we are enclosing as Appendix A hereto a
draft of the consolidated financial statements and related footnotes that the
Company proposes to include in its amended Annual Report on Form 10-K for the
fiscal year ended December 31, 2009, which includes draft disclosure of the
expected financial statement impact of the change in accounting treatment to
reflect the reclassification of the affected warrants from equity to a liability
in an amount equal to the fair value of the warrants, as of the dates of
issuance, calculated using the Black Scholes option pricing
model.   The restatement will not have an impact on any other
amounts previously reported, including Assets; Revenues; Research and
Development Expenses and other operating expenses; Cash Flows; Loans, Equipment
Loan and Accounts Payables; and Contractual Obligations.   It is
our intention to provide additional relevant draft disclosure to the Staff in
follow-up correspondence as soon as possible this week.

            Securities
and Exchange Commission

            November
8, 2010

            Page 6

                3.

                We refer to the
      representations in your previous response made by counsel on behalf
      ofthe
      registrant.  We would like the Company to make those
      representations.

      Response:

      The
Company hereby acknowledges that:

                  ·

                  the
      Company is responsible for the adequacy and accuracy of the disclosure in
      the filings;

                  ·

                  Staff
      comments or changes to disclosure in response to Staff comments do not
      foreclose the Commission from taking any action with respect to the
      filings; and

                  ·

                  the
      Company may not assert Staff comments as a defense in any proceeding
      initiated by the Commission or any person under the federal securities
      laws of the United States.

      If you
have any questions, or if we may be of any assistance, please do not hesitate to
contact the undersigned at (415) 488-9347 or Ira Kotel or Roland Chase at our
counsel, SNR Den

CORRESP
1
filename1.htm

    Unassociated Document

                SNR Denton US
      LLP

                Two
      World Financial Center

                225
      Liberty Street

                New
      York, NY 10281-2699 USA

                Ira
      L. Kotel

                Partner

                ira.kotel@snrdenton.com

                D    +1
      212 398 5787

                T    +1
      212 768 6700

                F    +1
      212 768 6800

                snrdenton.com

      VIA EDGAR
AND FAX

      202-772-9217

      October
1, 2010

      Mr. Jim
B. Rosenberg

      Senior
Assistant and Chief Accountant

      Division
of Corporation Finance

      United
States Securities and Exchange Commission

      100 F
Street, N.E.

      Washington,
D.C. 20549

                Re:

                Discovery
      Laboratories, Inc.

                Form
      10-K for the Year Ended December 31, 2009 (“2009 10-K”)

                Form
      10-K/A for the Year Ended December 31, 2009

                Forms
      10-Q for the Quarterly Periods Ended March 31 and June 30,
      2010

                File
      No. 000-26422

      Dear Mr.
Rosenberg

      We write
on behalf of our client, Discovery Laboratories, Inc. (the “Company”) in
response to the letter dated September 17, 2010 (the “2010 Comment Letter”) in
which the staff (the “Staff”) of the Securities and Exchange Commission (the
“Commission”) provided comments on the Company’s Annual Report on Form 10-K for
the Year Ended December 31, 2009 (“2009 10-K”), the amendment to such Annual
Report on Form 10-K/A and the Quarterly Reports on Form 10-Q for the Periods
Ended March 31 and June 30, 2010.  This letter sets forth the
Company’s responses to the 2010 Comment Letter.  For your convenience,
we have reproduced below in italics each comment and have provided the Company’s
response immediately below the comment.

      Form 10-K for the fiscal
year ended December 31, 2009

      Item
1.  Business

      Business
Operations

      Strategic Alliances and
Collaboration Arrangements

      Laboratorios del Dr. Esteve,
S.A.

      Philip Morris USA Inc. and
Philip Morris Products S.A., page 21

                Comment
      1.

                Please
      expand your disclosure of your agreement with Laboratorios del Dr. Esteve,
      S.A. to disclose the aggregate milestone payments, term and termination
      provisions of this agreement as these appear to be material terms of this
      agreement.  Similarly, please expand your disclosure of your
      agreements with Philip Morris USA Inc. and Philip Morris Products S.A. to
      disclose the termination provisions of these agreements and with Johnson
      & Johnson, Ortho Pharmaceutical Corporation and The Scripps Research
      Institute to disclose a range of royalty payments (e.g. low single digits
      or a range not to exceed ten percent), term and termination provisions of
      this agreement.

        Securities
and Exchange Commission

        October
1, 2010

        Page
2

      Response:                                The
Company acknowledges the Staff’s comment concerning its license agreements with
Laboratorios del Dr. Esteve, S.A. Philip Morris USA Inc., Philip Morris Products
S.A., and Johnson & Johnson (J&J) and Ortho Pharmaceutical Corporation
(Ortho), in the 2009 10-K,  and intends to provide additional disclosure
addressing the Staff's comment in its Form 10-Q for the fiscal quarter
ending September 30, 2010.  The Company wishes to point out to the
Staff that, although the Company's KL4 surfactant technology was
invented at The Scripps Research Institute (Scripps), it was licensed and
further developed by J&J.  The Company’s license agreement is with
J&J and its wholly-owned subsidiary, Ortho. Scripps is not a party to such
agreement.

      Management’s Discussion and
Analysis of Financial Condition and Results of Operations Research and
Development Expenses, page 49

                Comment
      2.

                For
      each of your pipeline projects as disclosed in Business beginning on page
      5 that you deem significant, disclose the following
      information.

      ·

                The
      costs incurred by you during each period presented and to date on the
      project;

      ·

                The
      nature, timing and estimated costs to be incurred by you necessary to
      complete the project;

                                                        ·

                The
      period in which material net cash inflows from significant projects are
      expected to commence; and

      ·

                The
      risks and uncertainties associated with completing development on schedule
      and the consequences to your operations, financial position and liquidity,
      if the project is not completed on a timely
  basis.

      Include
a description of your criteria for deeming a project to be
significant.  For those pipeline projects that you do not consider
significant, summarize the amounts charged to expense for each period by
therapeutic category.  Also, provide a general estimate of the nature,
timing and costs necessary to complete these projects.

        Securities
and Exchange Commission

        October
1, 2010

        Page
3

      Response:                                In
response to the Staff’s comment, we offer the following background:

      In
response to the Staff’s comment letter dated September 24, 2004 (the “2004
Comment Letter”), the Company added new disclosure to its Management’s
Discussion and Analysis (“MD&A”) that was intended to provide additional
information regarding its research and development activities and related
costs.  These changes were implemented in the Company’s Annual Report
on Form 10-K for the fiscal year ended December 31, 2004.

      Over the
next few years, the Company sought to reduce numerous redundancies that appeared
in its Annual Reports on Form 10-K, including in Business; MD&A – Research
and Development, – Plan of Operations, and – Results of Operations; and Risk
Factors.  Some disclosures were repeated several times in those
sections, as well as in the notes to the financial statements.  The
Company believed that these redundancies were potentially overly burdensome and
confusing to its stockholders.  In reviewing the 2009 10-K in response
to the Staff’s 2010 Comment Letter, however, it appears that certain information
previously intended to respond to the 2004 Comment Letter was inadvertently
omitted from MD&A, because it largely repeated disclosure
elsewhere in the 2009 10-K.

      Accordingly,
consistent with the approach that we took in response to the 2004 Comment
Letter, the Company proposes to add disclosure to “Research and Development
Expense” in its MD&A, including a new subpart titled “Research and
Development Projects”, that will address the Staff’s comments regarding the
Company’s research and development costs and related activities.

      As
further background, the Company notes that its research and development
activities generally form a foundation for the development of the Company’s
KL4
surfactant technology platform.  For the most part, the Company’s
research and development activities relate to, and benefit, all of the Company’s
surfactant projects.  For that reason, the Company’s research and
development expenses generally are incurred, and cannot be meaningfully
allocated, on a project-by-project basis.  The Company believes that
tracking such expenses by category is a more accurate method of accounting for
these activities.  Moreover, given the significant risks and
uncertainties inherent in the clinical development and regulatory approval
processes, the nature, timing and costs of the efforts necessary to complete
individual projects in development are not reasonably estimable.  In
developing its project plans, the Company anticipates project-based development
milestones and includes those milestones in its business strategy discussion,
but qualifies this disclosure by reference to the multiple risk factors that may
affect the timing or feasibility of such events.  The Company also
discloses throughout its Annual Report on Form 10-K, including in MD&A and
Risk Factors, that if it is not successful in gaining regulatory approval of its
drug product candidates, it will not be able to commercialize, or generate any
revenues from the sale of, its products and, as result, the value of the Company
and its financial condition and results of operations will be substantially
harmed.

        Securities
and Exchange Commission

        October
1, 2010

        Page
4

      For the
Staff’s review, we have set forth immediately below draft language using
historical information that illustrates by way of example the Company’s proposed
approach to revising the section on Research and Development Expenses in its
MD&A, including the additional “Research and Development Projects” subpart
that would be disclosed in the Company’s Annual Reports on Form 10-K, beginning
with the Annual Report on Form 10-K for the fiscal year ending December 31,
2010.  The Company would retain the new “Research and Development
Projects” subpart in its subsequent Forms 10-Q and provide appropriate updates
as required.   For the Staff’s convenience, the new language is
underlined .

      ______________________________

      Research
and Development Expenses

      Our
research and development expenses are charged to operations as incurred and we
track such costs by category rather than by project.  As many of our
research and development activities form a foundation for the development of our
KL4 surfactant technology platform, they benefit more than a single
project.  For that reason, we cannot reasonably estimate the costs or
our research and development activities on a project-by-project
basis.  We believe that tracking our expenses by category is a more
accurate method of accounting for these activities.  Our research and
development costs consist primarily of expenses associated with (a)
manufacturing development, (b) development operations, and (c) direct
pre-clinical and clinical programs.  We also track our research and
development expenses by category, including (i) salaries and benefits, (ii)
contracted services, (iii) rents and utilities, (iv) raw materials and supplies,
(v) stock-based compensation and (vi) other.

      Research
and development expenses for the years ended December 31, 2009, 2008 and 2007
were $19.1 million, $26.6 million and $26.2 million, respectively, as
follows:

                (Dollars
      in thousands)

                Year
      Ended December 31,

                Research
      and Development Expenses:

                2009

                2008

                2007

                Manufacturing
      development

              $
              9,118

              $
              14,165

              $
              11,888

                Development
      operations

              7,100

              9,113

              10,196

                Direct
      pre-clinical and clinical programs

              2,859

              3,288

              4,116

                Total
      Research and Development Expenses (1)

              $
              19,077

              $
              26,566

              $
              26,200

      Manufacturing
Development

      Manufacturing
development includes the cost of our manufacturing operations, quality assurance
and analytical chemistry capabilities to assure adequate production of clinical
and potential commercial drug supply for our KL4 surfactant products, in
conformance with current good manufacturing practices (cGMP).  These
costs include employee expenses, facility-related costs, depreciation, costs of
drug substances (including raw materials), supplies, quality control and
assurance activities and analytical services, etc.  Additionally, in
2008 costs included activities to address issues identified in an Approvable
Letter that we received from the FDA with respect to Surfaxin in May 2008 (May
2008 Approvable Letter).

        Securities
and Exchange Commission

        October
1, 2010

        Page
5

      The
decrease in manufacturing development expenses in 2009 as compared to 2008 is
primarily due to our efforts in 2009 to conserve financial resources following
receipt of the April 2009 Complete Response Letter.

      The
increase in manufacturing development expenses in 2008 as compared to 2007 is
primarily due to: (i) expenditures in 2008 to support our quality assurance
and analytical chemistry capabilities, including implementation and validation
of analytical methods and quality testing of drug product for our development
programs; (ii) activities related to preparation of the Complete Response to the
May 2008 Approvable Letter; and (iii) purchases of active ingredients for the
production of Surfaxin.

      Manufacturing
development expenses included charges of $0.4 million, $0.8 million and $0.7
million associated with stock-based employee compensation for the years ended
December 31, 2009, 2008, and 2007, respectively.

      Development
Operations

      Development
operations includes: (i) medical, scientific, clinical, regulatory, data
management and biostatistics activities in support of our KL4 surfactant
development programs; (ii) medical affairs activities to provide scientific
and medical education support in connection with our KL4 surfactant technology
pipeline programs; (iii) design and development for the manufacture of our
novel capillary aerosolization systems, including an aerosol generating device,
the disposable dose delivery packets and patient interface system necessary to
administer Aerosurf for our planned Phase 2 clinical trials and;
(iv) pharmaceutical development activities, including development of a
lyophilized (dry powder) formulation of our KL4 surfactant.  These
costs include personnel, expert consultants, outside services to support
regulatory, data management and device development activities, symposiums at key
neonatal medical meetings, facilities-related costs, and other costs for the
management of clinical trials.

      The
decrease in development operations expenses in 2009 as compared to 2008 is
primarily due to our efforts in 2009 to conserve financial resources and limit
investment in our KL4 respiratory pipeline programs following receipt of the
April 2009 Complete Response Letter.  The decrease in development
operations expenses in 2008 as compared to 2007 is primarily due to cost
reductions resulting from the relocation of our analytical testing and
pharmaceutical development activities previously performed at our laboratories
located in Doylestown, Pennsylvania, and Mountain View, California, and
consolidation of those activities into our new laboratory space in Warrington,
Pennsylvania, in the fourth quarter of 2007.  The decrease in 2008
from 2007 was partially offset by expenditures in  2008 associated
with our medical affairs capabilities, including medical science liaisons and
symposiums at key pediatric medical meetings in anticipation of the potential
approval and commercial launch of Surfaxin in May 2008.  Expenses
associated with medical affairs activities were $0.6 million, $2.0 million and
$0.8 million for the years ended December 31, 2009, 2008 and 2007,
respectively.

          Securities
and Exchange Commission

          October
1, 2010

          Page
6

      Development
operations expenses included charges of $0.3 million, $0.7 million and $0.9
million associated with stock-based employee compensation for the years ended
December 31, 2009, 2008, and 2007, respectively.

      Direct
Pre-Clinical and Clinical Programs

      Direct
pre-clinical and clinical programs include: (i) pre-clinical activities,
including toxicology studies and other pre-clinical studies to obtain data t

September 17, 2010

 Mr. John G. Cooper Executive Vice President and Chief Financial Officer
Discovery Laboratories, Inc. 2600 Kelly Road, Suite 100

Warrington, Pennsylvania 18976
 Re: Discovery Laboratories, Inc .
  Form 10-K for the Year Ended December 31, 2009
Form 10-K/A for the Year Ended December 31, 2009 Forms 10-Q for the Quarterly Period s Ended March 31 and June 30, 2010
 File No. 000-26422

Dear Mr. Cooper:

We have reviewed your filings and have th e following comments.  In our comments, we
ask you to provide us with information so  we may better underst and your disclosure.
 Please respond to this letter within te n business days by providing the requested
information or by advising us when you will provide the requested response.  Where a comment requests you to revise disclosu re, the information you provide s hould show us what the revised
disclosure will look like and identify the annual or quarterly filing, as applicable, in which you
intend to first include it.  If you do not be lieve a comment applies to your facts and
circumstances, please tell us why in your res ponse.  Please furnish us a letter on EDGAR under
the form type label CORRESP that ke ys your responses to our comments.
 After reviewing the information provided, we may raise additional comments and/or
request that you amend your filing.
Form 10-K for the fiscal year ended December 31, 2009

Item 1.  Business
Business Operations
Strategic Alliances and Collaboration Arrangements
Laboratorios del Dr. Esteve, S.A
Philip Morris USA Inc. and Philip Morris Products S.A., page 21

1. Please expand your disclosure of  your agreement with Laborat orios del Dr. Esteve, S.A.
to disclose the aggregate milestone payments , term and termination provisions of this

Mr. John G. Cooper
Discovery Laboratories, Inc.
September 17, 2010 Page 2
 agreement as these appear to be material terms of this agreement. Similarly, please
expand your disclosure of your agreements with Philip Morris USA Inc. and Philip Morris Products S.A. to disclose the termina tion provisions of these agreements and with
Johnson & Johnson, Ortho Pharmaceutical Co rporation and The Scripps Research
Institute to disclose a range of royalty paym ents (e.g. low single digits or a range not to
exceed ten percent), term and termination provisions of this agreement.
 Management’s Discussion and Analysis of Fi nancial Condition and Results of Operations

Research and Development Expenses, page 49
2. For each of your pipeline projects as disclo sed in Business beginning on page 5 that you
deem significant, disclose the following information.
• The costs incurred by you during each period presented and to date on the project;
• The nature, timing and estimated costs to be incurred by you necessary to complete
the project;
• The period in which material net cash inflow s from significant pr ojects are expected
to commence; and
• The risks and uncertainties associated with completing development on schedule and
the consequences to your operations, financia l position and liquidit y, if the project is
not completed on a timely basis.

Include a description of your cr iteria for deeming a project to be significant. For those
pipeline projects that you do not consider significant, summ arize the amounts charged to
expense for each period by therapeutic category.  Also, provide a general estimate of the
nature, timing and costs necessary  to complete these projects.

Controls and Procedures
(a) Evaluation of disclosure c ontrols and procedures, page 64
3. You disclose that your CEO and CFO evalua ted the effectiveness of the design and
operation of the company’s disclosure contro ls and procedures.  Please tell us why it
appears that their conclusion is limited to the design of those controls  and procedures and
that they do not appear to explicitly conc lude as to the operation of the company’s
disclosure controls and proce dures at the end of the period covered by the report.  This
comment also applies to your Forms 10-Q for the quarterly periods ended March 31,
2010 and June 30, 2010.
Form 10-K/A for the fiscal year ended December 31, 2009
Item 11. Executive Compensation
Compensation Discussion and Analysis
Executive Compensation Structure, page 8

4. You disclose that in deciding on total comp ensation packages for your executives, your
Compensation Committee considers, among other things and in addition to the Radford
Life Sciences Survey, compensation practices  of biotech and pharmaceutical companies

Mr. John G. Cooper
Discovery Laboratories, Inc.
September 17, 2010 Page 3
 that are similarly situated.  It appears that you use this data as a reference point on which,
wholly or in part, to ba se, justify or provide a framework for your compensation
decisions.  Please provide us with draft di sclosure of your 2010 compensation for future
filings which provides all the na mes of the companies included in these benchmarks.  If
you benchmarked against a survey in its en tirety, you may provide the name of the
survey.  See Question 118.05 of the Regul ation S-K Compliance and Disclosure
Interpretations.

Item 13.  Certain Relationships and Related Tran sactions, and Director Independence, page 26

5. Throughout the Business section of your Form 10-K you disclose that you have a license
and collaboration agreement with Laborator ios del Dr. Esteve, S.A.  Since this
relationship is ongoing and Dr. Esteve is one of your directors, it appears that this may be
related party transaction pursu ant to Item 404 of Regulation S-K.  Please revise to
provide the required disclosure  pursuant to Item 404 of Re gulation S-K.  Alternatively,
please provide us with an analysis that supports  your conclusion that this is not a related
party transaction pursuant to Item 404 of Regulation S-K.
 Form 10-Q for the quarterly period ended June 30, 2010

 Note 4 – Stockholder’s Equity, page 8

6. It appears that many of your  outstanding warrants were issued in conjunction with unit
offerings under shelf registration statements , including your May 2009 registered direct
offering, your February 2010 and June 2010 public offerings, your April 2010 offering
with PharmaBio and your June 2010 Committe d Equity Financing Facility with
Kingsbridge.  By operation of the U.S. Securi ties Laws the identified warrants can only
be settled with registered shares, which is  beyond your control, unless otherwise agreed
to by the holder.   Although the warrants a ssociated with these offerings have cashless
exercise provisions, it appears that the holder is not required to settle in unregistered
shares.  Please explain to us why you have not accounted for these warrants as derivative
liabilities.  In your response , please explain to us how you overcome the presumption in
ASC 815-40-25-14 that these warrants are net cas h settleable.  In a ddition, please clarify
whether any of your other outstanding warrant s were issued pursuant to registered
offerings and, if so, include those warra nts in the assessment requested above.

We urge all persons who are responsible for th e accuracy and adequacy of the disclosure
in the filing to be certain that the filing include s all information the Securities Exchange Act of
1934 and all applicable Exchange Act rules requir e.  Since the company and its management are
in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy
and adequacy of the disclosures they have made.

Mr. John G. Cooper
Discovery Laboratories, Inc.
September 17, 2010 Page 4
  In responding to our comments, please provi de a written statement from the company
acknowledging that:
• the company is responsible for the adequacy an d accuracy of the disclo sure in the filing;
• staff comments or changes to disclosure in response to staff comments do not foreclose
the Commission from taking any action with respect to the filing; and
• the company may not assert staff comments as  a defense in any proceeding initiated by
the Commission or any person under the federa l securities laws of  the United States.

You may contact Ibolya Igna t, Staff Accountant at (202)  551-3656 or Mark Brunhofer,
Accounting Reviewer, at (202) 551- 3638 if you have questions regarding the processing of your
response as well as any questions regarding co mments on the financial statements and related
matters.  You may contact Jennifer C. Riegel, Staff Attorney, at (202)  551-3575 with questions
on any of the other comments.  In this regard, do not hesitate to cont act me, at (202) 551-3679.

Sincerely,

Jim B. Rosenberg
Senior Assistant Chief Accountant

Mail Stop 4720
October 19, 2009
        David L. Lopez, C.P.A., Esq. Executive Vice President, General Counsel Discovery Laboratories, Inc. 2600 Kelly Road, Suite 100 Warrington, Pennsylvania 18976
Re: Discovery Laboratories, Inc
Preliminary Proxy Statement on Form PRE14A
  Filed October 9, 2009   File No. 000-26422

Dear Mr. Lopez:
We have completed our review of your Preliminary Proxy Statement on Form
PRE14A and have no further comments at this time.

     S i n c e r e l y ,                                                                 Jeffrey Riedler
                                                                                                 Assistant Director

CORRESP
1
filename1.htm

    Unassociated Document

    October
16, 2009

    Securities
and Exchange Commission

    Division
of Corporate Finance

    Mail Stop
4720

    100 F
Street, N.E.

    Washington,
D.C. 20549

              Attn:

              Mr.
      Jeffrey Riedler, Assistant Director

              Mr. Bryan Pitko,
  Attorney

    Discovery Laboratories, Inc.
--

    Preliminary Proxy Statement
on Form PRE14A (filed October 9, 2009)

    Dear
Messrs. Riedler and Pitko:

    On behalf
of Discovery Laboratories, Inc. (the “Company”), we are
transmitting for electronic filing via EDGAR pursuant to the Securities Act of
1933, as amended, proposed revisions to the language of the above-referenced
proxy statement (the “Proxy Statement”), as
originally filed with the Securities and Exchange Commission (the “Commission”) on
October 9, 2009.  If the revised language is acceptable to the staff
of the Division of Corporation Finance (the “Staff”), upon
receiving clearance from the Staff, we will file the amended language as part of
the definitive Proxy Statement on Form DEF14A.  We are writing this
letter in response to the comments of the Staff contained in your letter to the
Company dated October 15, 2009 (the “Comment Letter”),
regarding the Proxy Statement.  For the convenience of the Staff, we
have restated the contents of the Comment Letter and responded to the comments
in the order set forth therein.

    Preliminary Proxy Statement
on Form PRE14A (SEC File No. 000-26422)

    Comment
1.  Please revise your disclosure to describe any plans, arrangements or
understandings relating to the issuance of any of the authorized but unissued
shares that would be available as a result of your proposed increase in
authorized shares of common stock from 180 million shares to 380 million
shares.  If you have no such plans, arrangements or understandings,
please revise your disclosure to state so.

    Response:  In response to
Comment 1 of the Comment Letter, the Company has revised the Proxy Statement to
state that the Company currently has no plans, arrangements or understandings
relating to the issuance of any of the Company’s common stock by adding the
following language to the disclosure provided in Proposal 3 on page 14 of the
Proxy Statement:

    Although,
as described above, we are actively engaged in discussions with certain
interested parties with respect to potential strategic alliances and potential
additional financings, there are presently no confirmed plans, arrangements or
understandings with respect to any specific transaction that would result in the
issuance of any of the shares of  our Common Stock that would become
available for issuance if the Share Amendment were approved.

    ***

    If the
proposed changes to the Proxy Statement are acceptable to the Staff, we expect
to file the definitive Proxy Statement on Form DEF14A on or after October 19,
2009, once the comments are cleared or the Staff indicates that we may do
so.

    In
addition, please note that the Company has authorized us to inform you that it
acknowledges that it is responsible for the adequacy and accuracy of the
disclosure in the filings; that Staff comments or changes to the disclosure in
response to Staff comments in the filings do not foreclose the Commission from
taking any action with respect to the filing, and the Company may not assert
Staff comments as a defense in any proceeding initiated by the Commission or any
person under the federal securities law of the United States.

    Please do
not hesitate to contact me ((212) 277-6686) or my colleague, Stuart J. van
Leenen ((212) 277-6590), should you wish to discuss any matter
further.

              Very
      truly yours,

              /s/ Ira L.
      Kotel

              Ira
      L. Kotel

              (212)
      277-6686

              koteli@dicksteinshapiro.com

    Copy
to:

    David L.
Lopez, CPA, Esq.

    Executive
Vice President, General Counsel

    Discovery
Laboratories, Inc.

    2600
Kelly Road, Suite 100

    Warrington,
PA  18976

Mail Stop 4720
October 15, 2009
        David L. Lopez, C.P.A., Esq. Executive Vice President, General Counsel Discovery Laboratories, Inc. 2600 Kelly Road, Suite 100 Warrington, Pennsylvania 18976
Re: Discovery Laboratories, Inc
Preliminary Proxy Statement on Form PRE14A
  Filed October 9, 2009   File No. 000-26422

Dear Mr. Lopez:
This is to advise you that we have limited our review of the above proxy
statement to the issue identified below.  Where indicated, we think you should revise your documents in response to our comment.  If you disagree, we will consider your explanation as to why our comment is inapplicable or a revision is unnecessary.  Please be as detailed as necessary in your explanation.  In some of our comments, we may ask you to provide us with supplemental information so we may better understand your disclosure.  After reviewing this information, we may or may not raise additional comments.
 Please understand that the purpose of our review process is to assist you in your
compliance with the applicable disclosure requirements and to enhance the overall disclosure in your filing.  We look forward to working with you in these respects.  We welcome any questions you may have about our  comments or on any other aspect of our
review.  Feel free to call us at the telephone numbers listed at the end of this letter.

David L. Lopez, C.P.A., Esq.
Discovery Laboratories, Inc. October 15, 2009 Page 2
Preliminary Proxy Statement

Proposal 3: Proposal to Amend the Restated Ce rtificate of Incorporation, as amended, to
Increase the Number of Authorized Shares to 380 Million Shares, page 12

1. Please revise your disclosure to describe any plans, arrangements or
understandings relating to the issuance of any of the authorized but unissued shares that would be available as a result of your proposed increase in authorized shares of common stock from 180 million shares to 380 million shares.  If you have no such plans, arrangements or understandings, please revise your disclosure to state so.

* * *

As appropriate, please amend your filing in response to this comment.  Please
furnish a cover letter with your amendment that keys your responses to our comment and provides any requested supplemental information.  Detailed cover letters greatly facilitate our review.  Please file your cover letter on EDGAR under the form type label CORRESP.  Please understand that we may have additional comments after reviewing your amendment and responses to our comment.
 We urge all persons who are responsible for the accuracy and adequacy of the
disclosure in the filing to be certain that the filing includes all information required under the Securities Exchange Act of 1934 and that they have provided all information investors require for an informed investment decision.  Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made.
 In connection with responding to our comments, please provide, in writing, a
statement from the company acknowledging that:

• the company is responsible for the adequacy and accuracy of the disclosure in the
filing;

• staff comments or changes to disclosure in response to staff comments do not
foreclose the Commission from taking any action with respect to the filing; and

• the company may not assert staff comments as a defense in any proceeding initiated
by the Commission or any person under the federal securities laws of the United States.

David L. Lopez, C.P.A., Esq.
Discovery Laboratories, Inc. October 15, 2009 Page 3
In addition, please be advised that the Division of Enforcement has access to all
information you provide to the staff of the Di vision of Corporation Finance in our review
of your filing or in response to our comments on your filing.
 Please contact Bryan Pitko at (202) 551-3203 with any questions.  In this regard
please also feel free to contact me at (202) 551-3715.

     S i n c e r e l y ,                                                                 Jeffrey Riedler
                                                                                                 Assistant Director

CORRESP
1
filename1.htm

    Unassociated Document

    February
4, 2009

    Jeffrey
Reidler, Assistant Director

    Division
of Corporation Finance

    United
States Securities and Exchange Commission

    Mail Stop
6010, 100 F Street, NE

    Washington,
D.C. 20549

              Re:

              Discovery
      Laboratories, Inc.
Registration Statement on Form S-3
(File No.
      333-156237)

    Dear Mr.
Reidler:

    Discovery Laboratories, Inc., a
Delaware corporation (the “Company”), hereby requests that the effectiveness of
the Company’s Registration Statement on Form S-3, File No. 333-156237, be
accelerated to 12:30 p.m., February 6, 2009, or as soon thereafter as is
practicable.

    In connection with this letter, the
Company acknowledges that:

                ·

                Should
      the Commission or the staff, acting pursuant to delegated authority,
      declare the filing effective, it does not foreclose the Commission from
      taking any action with respect to the filing;

                ·

              The
      action of the Commission or the staff, acting pursuant to delegated
      authority, in declaring the filing effective, does not relieve the Company
      from its full responsibility for the adequacy and accuracy of the
      disclosure in the filing; and

                  ·

              The
      Company may not assert staff comments and the declaration of effectiveness
      as a defense in any proceeding initiated by the Commission or any person
      under the federal securities laws of the United
  States.

              Very
      truly yours,

              Discovery
      Laboratories, Inc.

                /s/
      Mary B. Templeton

                Mary
      B. Templeton, Esq.

                Senior
      Vice President,

              Deputy
      General Counsel

    Cc: Bryan
Pitko, Division of Corporate Finance, Securities and Exchange
Commission

CORRESP
1
filename1.htm

    Unassociated Document

    January
23, 2009

    Securities
and Exchange Commission

    Division
of Corporate Finance

    Mail Stop
6010

    100 F
Street, N.E.

    Washington,
D.C. 20549

                Attn:

                Mr.
      Jeffrey Riedler, Assistant Director

                Mr.
      Bryan Pitko, Attorney

    Discovery Laboratories, Inc.
—

    Registration Statement on
Form S-3 (SEC File No. 333-156237; filed December 17, 2008);

    Dear
Messrs. Riedler and Pitko:

    On behalf
of Discovery Laboratories, Inc. (the “Company”), we are
transmitting for electronic filing via EDGAR pursuant to the Securities Act of
1933, as amended, Amendment No. 1 (“Amendment No. 1”) to
the above-referenced registration statement (the “Registration
Statement”).  We are also submitting a hard copy of this letter
and a marked version of Amendment No.1 to show the changes from the Registration
Statement as originally filed with the Securities and Exchange Commission (the
“Commission”)
on December 17, 2008, to the staff of the Division of Corporation Finance (the
“Staff”).  We
are filing Amendment No. 1 in response to the comments of the Staff contained in
your letter to the Company dated January 9, 2009 (the “Comment Letter”),
regarding the Registration Statement.  For the convenience of the
Staff, we have restated the contents of the Comment Letter and responded to the
comments in the order set forth therein.  Page references in the text
of this letter correspond to the page numbers of the Prospectus contained in
Amendment No. 1.

    Registration Statement on
Form S-3 (SEC File No. 333-156237)

    Comment
1.  Please disclose the percentage of your outstanding securities that
the shares being registered for resale represent in the forepart of your
registration statement.

    Response:  In response to
Comment 1 of the Comment Letter, the Company has revised the Registration
Statement through Amendment No.1 to disclose in the forepart of the Registration
Statement that the 15,675,000 shares being registered for resale represent 15.4%
of the Company’s shares of common stock that were issued and outstanding on
January 20, 2009.

    Mr.
Jeffrey Riedler

    Mr. Bryan
Pitko

    January
23, 2009

    Page
2

    Comment
2.  Please revise your registration statement to disclose that
Kingsbridge's obligations under the common stock purchase agreement are not
transferable and that the registration statement does not cover sales by
transferees of Kingsbridge.

    Response:  In
response to Comment 2, the Company has revised the Registration Statement such
that the description of the transaction now includes the following disclosure
(see page
2):

    The
obligations of Kingsbridge under the Common Stock Purchase Agreement to purchase
shares of our common stock may not be transferred and the registration statement
does not cover sales of such shares by transferees of
Kingsbridge.  The rights of Kingsbridge to purchase shares of our
common stock under the Warrant may not be assigned or transferred except, under
certain conditions, to an affiliate of Kingsbridge.  If the Warrant is
transferred to an affiliate of Kingsbridge, the registration statement will
cover sales of any shares of our common stock that we issue to such affiliate of
Kingsbridge under the Warrant, but will not cover resale of shares of our common
stock by transferees of such affiliate of Kingsbridge.

    Comment
3.  Please expand your disclosure in the prospectus to discuss the
likelihood that you will receive, or will ever need, based on your disclosed
business plans, the full amount of proceeds available under the agreement. If
you are not likely to receive the full amount, please explain why you and
Kingsbridge chose the $25,000,000 amount of the equity line.

    Response:  In response to
Comment 3, to address the likelihood of the Company’s need to access the full
$25,000,000 amount of the Committed Equity Financing Facility (“CEFF”), the Company
has expanded its disclosure to include a discussion of the Company’s ongoing
plans to use equity and debt financing, including the use of equity lines, to
fund its operating activities.  To address the Company’s likelihood of
receiving the full amount potentially available under the CEFF, the Company has
re-iterated that, because of the minimum pricing conditions and other
restrictions that apply, as well as the fluctuations in the price of the
Company’s stock price, the Company may not be able to fully draw down the new
CEFF.  See page 3, which
includes the following added disclosure:

    Mr.
Jeffrey Riedler

    Mr. Bryan
Pitko

    January
23, 2009

    Page
3

    We have
no operating revenues and have funded our activities primarily through the
issuance of equity securities, debt and equipment financing
facilities.  From time to time, when and to the extent available in
the past, we used our CEFFs to support our working capital needs and to maintain
cash availability.  Recently, minimum price conditions have precluded
our accessing the Prior CEFFs.  We entered into the New CEFF because
we were concerned that we may be unable to adequately fund our activities in the
current difficult market environment.  If we are unable to secure
funding through CEFF draw downs or other means, such as financings, business
alliances, development partnerships or other similar opportunities, we may have
to reduce significantly the scope of, or discontinue, our planned research,
development and manufacturing activities, which could significantly harm our
financial condition and operating results.  We believe that we may
support execution of our business plan activities by exercising our right to
draw down amounts under the New CEFF (and potentially the Prior CEFFs), when and
to the extent available, when we believe that sales of stock under the CEFF
provide an appropriate means of raising capital.  There can be no
assurance, however, that we will be able to raise sufficient capital to fund our
planned activities when needed.  Nor, in light of the minimum price
conditions, can there be any assurance that we will issue all of the 15 million
shares that are available for issuance under the New CEFF.  In
addition, to draw down the total dollar amount available under the New CEFF, if
we were to issue all 15 million shares, the average purchase price per share for
the shares of common stock issued in all draw downs under the New CEFF taken in
the aggregate would have to equal at least $1.67 ($25 million divided by 15
million shares).  As the closing price of our common stock on January
20, 2009 was $1.12, even if we issue all 15 million shares that are available
for issuance under the New CEFF, there can be no assurance that we will succeed
in drawing down an aggregate of $25 million under the New CEFF.

    In
addition, the Company notes that the Registration Statement incorporates by
reference the Company’s periodic and quarterly filings that provide in-depth
disclosure regarding the Company’s most recent business plans, liquidity,
operating cash needs and uses of available financing, including the
CEFF.

    Comment
4.  Please fully discuss any securities or cash paid to Kingsbridge in
order to enter into the common stock purchase agreement and any additional fees
or commissions payable at the time the shares are put to Kingsbridge.
Specifically, please disclose whether the warrants issued to Kingsbridge were
provided as consideration for their entry into the common stock purchase
agreement.

    Response:  In response to
Comment 4, the Company has revised the Registration Statement to more
specifically disclose that, as consideration for the execution and delivery of
the common stock purchase agreement, the Company issued a warrant to purchase
675,000 shares of the Company’s common stock.  See page 2 of
Amendment No. 1.  The Company has also clarified that no fees or
commissions are payable to Kingsbridge under the common stock purchase agreement
in connection with the settlement of a draw down.  See page
3.

    Mr.
Jeffrey Riedler

    Mr. Bryan
Pitko

    January
23, 2009

    Page
4

    In
addition, the Plan of Distribution section of the Registration Statement
includes the following disclosure with respect to fees and expenses required to
be paid by the Company (see page
29):

    We have
agreed to pay the expenses of registering the shares of common stock under the
Securities Act, including registration and filing fees, printing expenses,
administrative expenses and certain legal and accounting fees, as well as
certain fees of counsel for the selling stockholder incurred in the preparation
of the CEFF agreements and the registration statement of which this prospectus
forms a part.  The selling stockholder will bear all discounts,
commissions or other amounts payable to underwriters, dealers or agents, as well
as transfer taxes and certain other expenses associated with the sale of
securities.

    Comment
5.  Please enhance the description of your past transactions with
Kingsbridge. In particular, please describe the impact that these transactions
have had on the market price of the company's stock.

    Response:  In response to
Comment 5, the Company has revised the Registration Statement to include
enhanced discussions of the Company’s past CEFF transactions with
Kingsbridge.  See pages 2, 5 and
6.

      To
address the Commission’s request that the Company describe the impact of the
transactions on the market price of the Company’s stock, the Company added
disclosure as follows (see page
5):

    Although
the number of shares of common stock that stockholders presently own will not
decrease, these shares will represent a smaller percentage of our total shares
that will be outstanding after any issuances of shares of common stock to
Kingsbridge.  Such dilution may result in a decrease in the market
value of our common stock.  Based on a review of the market price of
our common stock following draw downs under the Prior CEFFs, we cannot reliably
predict what effect, if any, draw-downs under the New CEFF will have on the
market value of our common stock.  However, if we draw down amounts
under the New CEFF when our share price is decreasing, we will need to issue
more shares to raise the same draw-down amount than if our stock price was
higher.  Such issuances will have a dilutive effect and may further
decrease our stock price.  See, Risk Factors — “Our Committed Equity
Financing Facilities may have a dilutive impact on our
stockholders”.

      Existing
disclosure in the Company’s risk factors also discuss, among other things, that
(i) a draw down under the CEFFs results in dilution of stockholder interests,
(ii) draw downs in declining markets may cause a stock price decrease and may
increase the dilutive effect of a draw down, (iii) sales by Kingsbridge may
result in a decrease in the Company’s stock price, and (iv) the perceived risk
of dilution from sales by Kingsbridge may cause sales, including short sales,
resulting in a declining stock price (see pages
16-17).

    Mr.
Jeffrey Riedler

    Mr. Bryan
Pitko

    January
23, 2009

    Page
5

      It should
be noted, however, that the Company cannot reliably separate the impact of CEFF
draw downs on its market price from other factors that may be affecting its
stock price at any given time.  In the Company’s experience, CEFF
draws are not consistently followed by a predictable change in stock
price.  Rather, the Company has observed that, following a CEFF draw,
the price may remain stable, may increase, or may decrease.

    Comment
6.  Please expand your risk factors to discuss the likelihood that you
will have access to the full amount under the equity line.

    Response:  In response to
Comment 6, the Company has revised the Registration Statement to add the
following discussion to its risk factors (see page
16):

    We
currently expect to consider supporting our activities by exercising our right
to draw down amounts under the New CEFF and the Prior CEFFs, if available, when
we believe that sales of stock under a CEFF provide an appropriate means of
raising capital.  However, if conditions, including minimum price
limitations, under a CEFF are not met, we may be unable to raise sufficient
capital to execute our business strategy.  There can be no assurance,
that we will be able to utilize the CEFFs to raise sufficient capital to fund
our planned activities when needed.  Nor can there  be any
assurance that we will issue all of the 15 million shares that are available
under the New CEFF or the remaining shares that are available under the Prior
CEFFs.  In addition, if the market value of our common stock does not
increase over time, even if we issue all shares available for issuance under the
New CEFF and Prior CEFFs, there can be no assurance that we will succeed in
drawing down an aggregate $25 million under the New CEFF or the balance of
funds that are available under the Prior CEFFs.

    The
Company has also added the sentence underlined below to the risk factor that
discusses CEFF dilution (see page
17):

    If we are
unable to meet the conditions provided under the CEFFs, we may not be able to
issue any portion of the shares potentially available for issuance for future
financings, subject to the terms and conditions of the CEFFs.  Moreover, even if we are
able to issue all shares available for issuance, if the VWAP of our common stock
during any CEFF draw is at or near the minimum price requirement, we may be
unable to realize the full dollar value potentially available under each
CEFF.

    Mr.
Jeffrey Riedler

    Mr. Bryan
Pitko

    January
23, 2009

    Page
6

    ***

    If the
proposed changes to the Registration Statement are acceptable, we expect to seek
to have the Registration Statement declared effective by the Commission as soon
as practicable, and will submit an appropriate request to do so once the
comments are cleared or the Staff indicates that we may do so.

    In
addition, please note that the Company has authorized us to inform you that it
acknowledges that it is responsible for the adequacy and accuracy of the
disclosure in the filings; that Staff comments or changes to the disclosure in
response to Staff comments in the filings do not foreclose the Commission from
taking any action with respect to the filing, and the Company may not assert
Staff comments as a defense in any proceeding initiated by the Commission or any
person under the federal securities law of the United States.

    Please do
not hesitate to contact me ((212) 277-6686) or my colleague, Stuart J. van
Leenen ((212) 277-6590), should you wish to discuss any matter
further.

                Very
      truly yours,

                /s/ Ira L. Kotel

                Ira
      L. Kotel

                (212)
      277-6686

                koteli@dicksteinshapiro.com

    Copy
to:

    David L.
Lopez, CPA, Esq.

    Executive
Vice President, General Counsel

    Discovery
Laboratories, Inc.

    2600
Kelly Road, Suite 100

    Warrington,
PA  18976

Mail Stop 6010                                                                                                   January 9, 2009

David L. Lopez, C.P.A., Esq.
Executive Vice President, General Counsel Discovery Laboratories, Inc. 2600 Kelly Road, Suite 100 Warrington, Pennsylvania 18976
Re: Discovery Laboratories, Inc
  Registration Statement on Form S-3    Filed December 17, 2008   File No. 333-156237

Dear Mr. Lopez:

We have reviewed your filing and have th e following comments.  Where indicated, we
think you should revise your document in response to these comments.  If you disagree, we will
consider your explanation as to why our comments are inapplicable or a revi sion is unnecessary.  In
some of our comments, we may ask you to provi de us with information so we may better
understand your disclosure.  After reviewing this information, we may raise additional comments.
  Please understand that the purpose of our review process is to  assist you in your compliance
with the applicable disclosure re quirements and to enhance the ove rall disclosure in your filing.
We look forward to working with you in these re spects.  We welcome any questions you may have
about our comments or on any other aspect of our review.  Feel free to ca ll us at the telephone
numbers listed at the end of this letter.  Form S-3

 General

 1. Please disclose the percentage of your outstandi ng securities that the sh ares being registered
for resale represent in the forepart  of your registration statement.

2. Please revise your registration st atement to disclose that Kingsbridge’s obligations under
the common stock purchase agreement are no t transferable and that the registration
statement does not cover sales by transferees of Kingsbridge.

David L. Lopez, C.P.A., Esq.
Discovery Laboratories, Inc. January 9, 2009
3. Please expand your disclosure in the prosp ectus to discuss the likelihood that you will
receive, or will ever need, based on your di sclosed business plans, the full amount of
proceeds available under the agreement. If you are not likely to receive the full amount,
please explain why you and Kingsbridge chos e the $25,000,000 amount of the equity line.

4. Please fully discuss any securities or cash paid to Kingsbridge in order to enter into the
common stock purchase agreement and any addi tional fees or commissions payable at the
time the shares are put to Kingsbridge.  Speci fically, please disclose whether the warrants
issued to Kingsbridge were provided as consid eration for their entry into the common stock
purchase agreement.

5. Please enhance the description of your past tran sactions with Kingsbri dge.  In particular,
please describe the impact that these transa ctions have had on the market price of the
company’s stock.
 Risk Factors, page 5

6. Please expand your risk factors to discuss th e likelihood that you will have access to the full
amount under the equity line.

*    *    *    *

As appropriate, please amend your registration statement in response to these comments.
You may wish to provide us with marked copies of the amendment to expe dite our review.  Please
furnish a cover letter with your amendment that ke ys your responses to ou r comments and provides
any requested information.  Detailed  letters greatly facilitate our re view.  Please understand that we
may have additional comments after reviewing your amendment and responses to our comments.      We urge all persons who are responsible for the accuracy and adequacy of the disclosure in
the filing to be certain that the filing include s all information required under the Securities
Exchange Act of 1933 and that they have provi ded all information investors require for an
informed investment decision.  Since the compa ny and its management are in possession of all
facts relating to a company’s disc losure, they are responsible for th e accuracy and adequacy of the
disclosures they have made.
 Notwithstanding our comments, in the ev ent the company reque sts acceleration of
the effective date of the pending re gistration statement, it should furnish a letter, at the time of such
request, acknowledging that:     should the Commission or the staff, acting pursua nt to delegated authority, declare the filing
effective, it does not foreclose the Commission from taking any action with respect to the
filing;

David L. Lopez, C.P.A., Esq.
Discovery Laboratories, Inc. January 9, 2009    the action of the Commission or the staff, acti ng pursuant to delegated authority, in declaring
the filing effective, does not re lieve the company from its full responsibility for the adequacy
and accuracy of the disclosure in the filing; and
   the company may not assert staff comments and th e declaration of effectiveness as a defense in
any proceeding initiated by the Commission or a ny person under the federal securities laws of
the United States.
  In addition, please be advised th at the Division of Enforcement has access to all information
you provide to the staff of the Di vision of Corporation Finance in  connection with our review of
your filing or in response to our comments on your filing.
We will consider a written request for acceleration of the effective date of the registration
statement as confirmation of the f act that those requesting accelera tion are aware of their respective
responsibilities under the Securities Act of 1933 and the Securiti es Exchange Act of 1934 as they
relate to the proposed public offeri ng of the securities sp ecified in the above registration statement.
We will act on the request and, pursuant to delegate d authority, grant acceleration of the effective
date.
 We direct your attention to Rules 460 and 461 regarding requesting acceleration of a
registration statement.  Please a llow adequate time after the fili ng of any amendment for further
review before submitting a request for acceleration.  Please provide this request at least two
business days in advance of the requested effective date.
 Please contact Bryan Pitko at  (202) 551-3203 or Suzanne Haye s at (202) 551-3675 with any
questions.   In this regard , please also feel free to c ontact me at (202) 551-3715.

Sincerely,

Jeffrey Riedler  Assistant Director
  cc:  Ira L. Kotel, Esq.
Dickstein Shapiro LLP 1177 Avenue of the Americas, 47th Floor New York, New York 10036-2714