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SEC Company Response from WINDTREE THERAPEUTICS (WINT) — Nov 12, 2010

WINDTREE THERAPEUTICS INC /DE/ (WINT, WINTW) (CIK 0000946486)
Date: Nov. 12, 2010 · CIK: 0000946486 · Accession: 0001144204-10-059402

AI Filing Summary & Sentiment

Sentiment
Urgency
Document Type
Confidence
SEC Posture
Company Posture

Summary

Reasoning

File numbers found in text: 000-26422

Date
Nov. 12, 2010
Author
/s/ Mary
Form
CORRESP
Company
WINDTREE THERAPEUTICS INC /DE/ (WINT, WINTW) (CIK 0000946486)

Letter

VIA EDGAR Division of Corporation Finance United States Securities and Exchange Commission 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, 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

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

Show Raw Text
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