SecProbe.io

CORRESP
 1
 filename1.htm

 CORRESP

 May 7, 2026
 VIA EDGAR Division of Corporation Finance
 Office of Life Sciences United States Securities and Exchange
Commission 100 F Street, N.E. Washington, D.C. 20549-3628
 Attention: Lauren Hamill

 Re:
 Request for Effectiveness for Eledon Pharmaceuticals, Inc.
 Registration Statement on Form S-3 (File
No. 333-295498) Dear Ms. Hamill:
 Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, Eledon Pharmaceuticals, Inc. (the
“ Registrant ”) hereby respectfully requests that the effectiveness of the above-referenced Registration Statement be accelerated to 4:00 p.m. Eastern Time, on May 11, 2026, or as soon thereafter as practicable. The Registrant
respectfully requests that you notify Shelly Heyduk of O’Melveny & Myers LLP of such effectiveness by telephone at (949) 823-7968.
 If you have any questions or comments regarding the foregoing, please do not hesitate to contact Ms. Heyduk at the telephone number
above.

 Very truly yours,

 Eledon Pharmaceuticals, Inc.

 By:

 /s/ Paul Little

 Name:  Paul Little

 Title:   Chief Financial Officer

 cc:
 Shelly Heyduk, O’Melveny & Myers LLP

<DOCUMENT>
<TYPE>TEXT-EXTRACT
<SEQUENCE>2
<FILENAME>filename2.txt
<TEXT>
 May 7, 2026

David-Alexandre Gros
Chief Executive Officer
Eledon Pharmaceuticals, Inc.
19800 MacArthur Blvd., Suite 250
Irvine, CA 92612

 Re: Eledon Pharmaceuticals, Inc.
 Registration Statement on Form S-3
 Filed May 1, 2026
 File No. 333-295498
Dear David-Alexandre Gros:

 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: Shelly Heyduk
</TEXT>
</DOCUMENT>

CORRESP
1
filename1.htm

  CORRESP

  September 30, 2024

  VIA EDGAR

  Division of Corporation Finance

  Office of Life Sciences

  United States Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549-3628

  Attention: Christopher Edwards

  Re:	Request for Effectiveness for Eledon Pharmaceuticals, Inc.

  	Registration Statement on Form S-3 (File No. 333-282260)

  Dear Mr. Edwards:

  Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, Eledon Pharmaceuticals, Inc. (the “Registrant”) hereby respectfully requests that the effectiveness of the above-referenced Registration Statement be accelerated to 10:00 a.m. Eastern Time, on October 2, 2024, or as soon thereafter as practicable. The Registrant respectfully requests that you notify Shelly Heyduk of O’Melveny & Myers LLP of such effectiveness by telephone at (949) 823-7968.

  If you have any questions or comments regarding the foregoing, please do not hesitate to contact Ms. Heyduk at the telephone number above.

  Very truly yours,

  Eledon Pharmaceuticals, Inc.

  By: /s/ Paul Little

  	Name:	Paul Little

  	Title:	Chief Financial Officer

  cc:	Shelly Heyduk, O’Melveny & Myers LLP

September 26, 2024
David-Alexandre C. Gros
Chief Executive Officer
Eledon Pharmaceuticals, Inc.
19800 MacArthur Blvd., Suite 250
Irvine, California 92612
Re:Eledon Pharmaceuticals, Inc.
Registration Statement on Form S-3
Filed September 20, 2024
File No. 333-282260
Dear David-Alexandre C. Gros:
            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 Chris Edwards at 202-551-6761 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Shelly Heyduk

CORRESP
1
filename1.htm

  CORRESP

  June 3, 2024

  VIA EDGAR

  Division of Corporation Finance

  Office of Life Sciences

  United States Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549-3628

  Attention: Lauren Hamill

  Re:	Request for Effectiveness for Eledon Pharmaceuticals, Inc.

  		Registration Statement on Form S-3 (File No. 333-279711)

  Dear Ms. Hamill:

  Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, Eledon Pharmaceuticals, Inc. (the “Registrant”) hereby respectfully requests that the effectiveness of the above-referenced Registration Statement be accelerated to 10:00 a.m. Eastern Time, on Wednesday, June 5, 2024, or as soon thereafter as practicable. The Registrant respectfully requests that you notify Shelly Heyduk of O’Melveny & Myers LLP of such effectiveness by telephone at (949) 823-7968.

  If you have any questions or comments regarding the foregoing, please do not hesitate to contact Ms. Heyduk at the telephone number above.

  Very truly yours,

  Eledon Pharmaceuticals, Inc.

  By: /s/ Paul Little

         Name:   Paul Little

         Title:     Chief Financial Officer

  cc:	Shelly Heyduk, O’Melveny & Myers LLP

United States securities and exchange commission logo
May 30, 2024
David-Alexandre Gros
Chief Executive Officer
Eledon Pharmaceuticals, Inc.
19800 MacArthur Blvd., Suite 250
Irvine, CA 92612
Re:Eledon Pharmaceuticals, Inc.
Registration Statement on Form S-3
Filed May 24, 2024
File No. 333-279711
Dear David-Alexandre Gros:
            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:       Shelly Heyduk

CORRESP
1
filename1.htm

CORRESP

 May 31, 2023

VIA EDGAR

 Division of Corporation Finance

Office of Life Sciences

 United States Securities and Exchange
Commission

 100 F Street, N.E.

 Washington, D.C. 20549-3628

 Attention: Cindy Polynice

Re:
 Request for Effectiveness for Eledon Pharmaceuticals, Inc.

Registration Statement on Form S-3 (File
No. 333-272052)

 Dear Ms. Polynice:

Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, Eledon Pharmaceuticals, Inc. (the “Registrant”)
hereby respectfully requests that the effectiveness of the above-referenced Registration Statement be accelerated to 10:00 a.m. Eastern Time, on Friday, June 2, 2023, or as soon thereafter as practicable. The Registrant respectfully requests that
you notify Shelly Heyduk of O’Melveny & Myers LLP of such effectiveness by telephone at (949) 823-7968.

If you have any questions or comments regarding the foregoing, please do not hesitate to contact Ms. Heyduk at the telephone number
above.

Very truly yours,

Eledon Pharmaceuticals, Inc.

By:

 /s/ Paul Little

Name: Paul Little

Title: Chief Financial Officer

cc:
 Shelly Heyduk, O’Melveny & Myers LLP

United States securities and exchange commission logo
May 24, 2023
Dr. David-Alexandre Gros
Chief Executive Officer
Eledon Pharmaceuticals, Inc.
19900 MacArthur Blvd., Suite 550
Irvine, California 92612
Re:Eledon Pharmaceuticals, Inc.
Registration Statement on Form S-3
Filed May 18, 2023
File No. 333-272052
Dear Dr. David-Alexandre Gros:
            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 Cindy Polynice at 202-551-8707 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Shelly Heyduk, Esq.

CORRESP
1
filename1.htm

CORRESP

 ELEDON PHARMACEUTICALS, INC.

19900 MacArthur Boulevard, Suite 550

Irvine, California

 VIA EDGAR

 May 18, 2021

 United States Securities
and Exchange Commission

 Division of Corporation Finance

Office of Life Sciences

 100 F Street, N.E.

Washington, D.C. 20549

Re:
 Eledon Pharmaceuticals, Inc.

 Registration Statement on Form S-3 (File No. 333-254890)

 To Whom it May Concern:

Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), Eledon Pharmaceuticals, Inc. (the
“Company”) hereby requests that the effective date of the above-referenced registration statement (the “Registration Statement”) be accelerated to May 20, 2021, at 4:00
p.m., Eastern Time, or as soon thereafter as practicable, unless we or our outside counsel, Gibson, Dunn & Crutcher LLP, request by telephone that such Registration Statement be declared effective at some other time. In making this
acceleration request, the Company acknowledges that it is aware of its obligations under the Act.

 Once the Registration Statement is
effective, please orally confirm the event with our counsel, Gibson, Dunn & Crutcher LLP by calling Ryan A. Murr at (415) 393-8373.

 Sincerely,

ELEDON PHARMACEUTICALS, INC.

/s/ Paul Little

 Paul Little

 Chief Financial
Officer

cc:
 Ryan A. Murr, Gibson, Dunn & Crutcher LLP

United States securities and exchange commission logo
April 5, 2021
David-Alexandre C. Gros
Chief Executive Officer
Eledon Pharmaceuticals, Inc.
19900 MacArthur Blvd., Suite 550
Irvine, CA 92612
Re:Eledon Pharmaceuticals, Inc.
Registration Statement on Form S-3
Filed March 31, 2021
File No. 333-254890
Dear Mr. Gros:
            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,
Division of Corporation Finance
Office of Life Sciences
cc:       Ryan A. Murr, Esq.

CORRESP
1
filename1.htm

CORRESP

 December 17, 2020

United States Securities and Exchange Commission

 Division of
Corporation Finance

 Office of Life Sciences

 100 F Street,
NE

 Washington, D.C. 20549-3561

Attn:
 David Gessert

Re:
 Novus Therapeutics, Inc. Registration Statement on Form S-3, filed
December 11, 2020, file No. 333-251305

 Dear
Mr. Gessert,

 Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, we hereby request acceleration of the
effective date of the above-referenced Registration Statement on Form S-3 (File No. 333-251305) of Novus Therapeutics, Inc. so that it may become effective at 4:00
p.m., Eastern Time, on December 22, 2020, or as soon as possible thereafter.

 If you have any questions, please contact Ryan A. Murr (415-393-8373) of Gibson, Dunn & Crutcher LLP.

Sincerely,

NOVUS THERAPEUTICS, INC.

By:

 /s/ David-Alexandre C. Gros

David-Alexandre C. Gros

Chief Executive Officer

cc:
 Ryan A. Murr, Gibson, Dunn & Crutcher LLP

United States securities and exchange commission logo
December 16, 2020
David-Alexandre C. Gros, M.D.
Chief Executive Officer
Novus Therapeutics, Inc.
19900 MacArthur Blvd., Suite 550
Irvine, CA 92612
Re:Novus Therapeutics, Inc.
Registration Statement on Form S-3
Filed December 11, 2020
File No. 333-251305
Dear Mr. Gros:
            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 David Gessert at 202-551-2326 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences

United States securities and exchange commission logo
November 20, 2020
David-Alexandre Gros
Chief Executive Officer
Novus Therapeutics, Inc.
19900 MacArthur Blvd., Suite 550
Irvine, CA 92612
Re:Novus Therapeutics, Inc.
Preliminary Proxy Statement on Schedule 14A
Filed October 23, 2020
File No. 001-36620
Dear Dr. Gros:
            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:       Ryan A. Murr

CORRESP
1
filename1.htm

CORRESP

 Ryan A.
Murr

 Direct: +1
415.393.8373

 Fax: +1 415.374.8430

RMurr@gibsondunn.com

 November 13, 2020

Via EDGAR Submission

 United States Securities and
Exchange Commission

 Division of Corporation Finance

 Office
of Life Sciences

 100 F Street, N.E.

 Washington, D.C. 20549

 Attention: Jason Drory and Joe McCann

Re:
 Novus Therapeutics, Inc.

Preliminary Proxy Statement on Schedule 14A

Filed October 23, 2020 (amended November 13, 2020)

File No. 001-36620

 Dear Mr. Drory and
Mr. McCann

 Novus Therapeutics, Inc. (the “Company”) has filed today with the Securities and Exchange Commission (the
“Commission”) Amendment No. 1 (“Amendment No. 1”) to the Company’s Preliminary Proxy Statement on Schedule 14A, initially filed with the Commission on October 23, 2020 (File
No. 001-36620) (the “Preliminary Proxy Statement”). This letter, together with Amendment No. 1, sets forth the Company’s responses to the comments contained in a letter from the staff
of the Commission (the “Staff”), dated November 6, 2020 (the “Comment Letter”), relating to the Preliminary Proxy Statement. The responses set forth herein are based upon information provided to Gibson, Dunn &
Crutcher LLP by the Company. The responses are keyed to the numbering of the comments in the Comment Letter and to the headings used in the Comment Letter.

Terms used but not otherwise defined in this letter have the respective meanings ascribed to such terms in Amendment No. 1 to the Preliminary Proxy
Statement. Page references in the responses set forth below are to pages in the clean copy of Amendment No. 1. The Company respectfully requests that the Staff confirm that it has no further comments to the Preliminary Proxy Statement so that
it may file a Definitive Proxy Statement on Schedule 14A on November 20, 2020, or as soon as practicable thereafter.

 On behalf of the Company, we
advise you as follows:

 Reasons for the Transactions, page 13

1.
 We note your disclosure that Novus and its management team negotiated the “most favorable equity
split” for Novus stockholders. Please revise your disclosure to quantify the equity split by providing the actual percentage ownership existing Novus stockholders will own on a fully-diluted basis following the Anelixis Acquisition.

 Response: In response to the Staff’s comment, the Company has revised the disclosure on page 13 of
Amendment No. 1 to the Preliminary Proxy Statement to add the requested information regarding the percentage ownership retained by legacy Novus stockholders.

2.
 We note your disclosure that your board of directors considered the Anelixis Acquisition to be more
favorable to your stockholders than a potential liquidation. Please revise to quantify the liquidation value considered by the Board and discuss the basis for the calculation and any material assumptions.

Response: In response to the Staff’s comment, the Company has revised the disclosure on page 13 of Amendment No. 1 to the
Preliminary Proxy Statement to add the requested information regarding the estimated liquidation value at various points in time and the factors affecting such value.

 United States Securities and Exchange Commission

Division of Corporation Finance

 Office of Life Sciences

November 12, 2020

 Page 2

 Proposal No. 1: Approval of Conversion Proposal, page 46

3.
 We note that your Proposal No.1 Approval of Conversion Proposal is a result of your acquisition of
Anelixis. Please revise your proxy statement to provide all of the information relating to Anelixis and the acquisition that is required by Item 14(b)(7) of Schedule 14A, including the information required by Items 1005(b) and 1011(a)(1) of
Regulation M-A. Please refer to Note A of Schedule 14A.

 Response: As
discussed with the Staff in a telephone conference call on November 10, 2020, the Company has revised the disclosure on pages 13 and 47 of Amendment No. 1 to the Preliminary Proxy Statement to provide enhanced disclosure regarding the
background of the Anelixis Acquisition and the interests of certain parties in the Acquisition.

4.
 We note your table under the subheading “Shares Issuable Upon Conversion.” Please revise this
section to indicate the total number of shares of common stock issued and reserved for issuance upon the approval of this conversion proposal. In addition, please disclose the aggregate shares of common stock issuable upon conversion in your
narrative “Overview” sub-section directly above.

 Response:
In response to the Staff’s comment, the Company has revised the disclosure on page 47 of Amendment No. 1 to the Preliminary Proxy Statement to include the requested total share information. We note that the Company intends to complete
this information in the definitive proxy statement once the size of the equity plan that is the subject of Proposal No. 2 has been approved by the Novus Board of Directors.

GIBSON, DUNN & CRUTCHER LLP

 /s/ Ryan A. Murr

Ryan A. Murr

cc:
 David-Alexandre Gros, Chief Executive Officer, Novus Therapeutics, Inc.

 James J. Moloney, Gibson Dunn & Crutcher LLP

United States securities and exchange commission logo
November 6, 2020
David-Alexandre Gros
Chief Executive Officer
Novus Therapeutics, Inc.
19900 MacArthur Blvd., Suite 550
Irvine, CA 92612
Re:Novus Therapeutics, Inc.
Preliminary Proxy Statement on Schedule 14A
Filed October 23, 2020
File No. 001-36620
Dear Dr. Gros:
            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.
Preliminary Proxy Statement on Schedule 14A Filed October 23, 2020
Reasons for the Transactions, page 13
1.We note your disclosure that Novus and its management team negotiated the "most
favorable equity split" for Novus stockholders. Please revise your disclosure to quantify
the equity split by providing the actual percentage ownership existing Novus stockholders
will own on a fully-diluted basis following the Anelixis Acquisition.
2.We note your disclosure that your board of directors considered the Anelixis Acquisition
to be more favorable to your stockholders than a potential liquidation. Please revise to
quantify the liquidation value considered by the Board and discuss the basis for the
calculation and any material assumptions.

 FirstName LastNameDavid-Alexandre Gros
 Comapany NameNovus Therapeutics, Inc.
 November 6, 2020 Page 2
 FirstName LastName
David-Alexandre Gros
Novus Therapeutics, Inc.
November 6, 2020
Page 2
Proposal No. 1: Approval of Conversion Proposal, page 46
3.We note that your Proposal No.1 Approval of Conversion Proposal is a result of your
acquisition of Anelixis. Please revise your proxy statement to provide all of the
information relating to Anelixis and the acquisition that is required by Item 14(b)(7) of
Schedule 14A, including the information required by Items 1005(b) and 1011(a)(1) of
Regulation M-A. Please refer to Note A of Schedule 14A.
4.We note your table under the subheading "Shares Issuable Upon Conversion." Please
revise this section to indicate the total number of shares of common stock issued and
reserved for issuance upon the approval of this conversion proposal. In addition,
please disclose the aggregate shares of common stock issuable upon conversion in your
narrative "Overview" sub-section directly above.
            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 Jason Drory at (202) 551-8342 or Joe McCann at (202) 551-6262 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences

CORRESP
1
filename1.htm

nvus-corresp.DOCX.htm

Novus Therapeutics, Inc.

19900 MacArthur Blvd., Suite 550

Irvine, CA 92612

(949) 238-8090

April 2, 2020

VIA EDGAR

Securities and Exchange Commission

Division of Corporation Finance

100 F Street, N.E.

Washington, DC 20549

Attn:

 Christine Westbrook

Re:

Novus Therapeutics, Inc.

Registration Statement on Form S-1

Filed March 25, 2020

File No. 333-237379

Ladies and Gentlemen:

Pursuant to Rules 460 and 461 promulgated under the Securities Act of 1933, as amended, Novus Therapeutics, Inc., a Delaware corporation (the “Company”), hereby respectfully requests that the effective time of the above referenced Registration Statement on Form S-1 filed by the Company (the “Registration Statement”) be accelerated to 4:01 p.m., Eastern Standard Time, on April 3, 2020 or as soon thereafter as practicable.

[Signature page follows]

Very truly yours,

Novus Therapeutics, Inc.

By:

/s/ Gregory J. Flesher

Name:

Gregory J. Flesher

Title:

Chief Executive Officer

cc:

Ryan A. Murr, Gibson, Dunn & Crutcher LLP

March 31, 2020
Gregory J. Flesher
Chief Executive Officer
Novus Therapeutics, Inc.
19900 MacArthur Blvd., Suite 550
Irvine, CA 92612
Re:Novus Therapeutics, Inc.
Registration Statement on Form S-1
Filed March 25, 2020
File No. 333-237379
Dear Mr. Flesher:
            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 Christine Westbrook at 202-551-5019 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:       Ryan A. Murr, Esq.

CORRESP
1
filename1.htm

CORRESP

 Novus Therapeutics, Inc.

19900 MacArthur Blvd., Suite 550

 Irvine, CA 92612

(949) 238-8090

June 14, 2019

 VIA EDGAR

Securities and Exchange Commission

 Division of Corporation
Finance

 100 F Street, N.E.

 Washington, DC 20549

Attn:
 Sonia Bednarowski

Re:
 Novus Therapeutics, Inc.

Registration Statement on Form S-1

Filed June 7, 2019

File No. 333-232011

Ladies and Gentlemen:

 Pursuant to Rules 460
and 461 promulgated under the Securities Act of 1933, as amended, Novus Therapeutics, Inc., a Delaware corporation (the “Company”), hereby respectfully requests that the effective time of the above referenced Registration Statement on Form
S-1 filed by the Company (the “Registration Statement”) be accelerated to 4:01 p.m., Eastern Daylight Time, on June 17, 2019 or as soon thereafter as practicable.

[Signature page follows]

Very truly yours,

Novus Therapeutics, Inc.

By:

 /s/ Gregory J. Flesher

Name:

Gregory J. Flesher

Title:

Chief Executive Officer

cc:
 Ryan A. Murr, Gibson, Dunn & Crutcher LLP

June 12, 2019
Gregory Flesher
Chief Executive Officer
Novus Therapeutics, Inc.
19900 MacArthur Blvd., Suite 550
Irvine, CA 92612
Re:Novus Therapeutics, Inc.
Registration Statement on Form S-1
Filed June 7, 2019
File No. 333-232011
Dear Mr. Flesher:
            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 Sonia Bednarowski at 202-551-3666 with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance

July 30, 2018
Gregory J. Flesher
Chief Executive Officer
Novus Therapeutics, Inc.
19900 MacArthur Blvd., Suite 550
Irvine, California 92612
Re:Novus Therapeutics, Inc.
Registration Statement on Form S-3
Filed July 23, 2018
File No. 333-226286
Dear Mr. Flesher:
            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 Irene Paik at 202-551-6553 with any questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc:       Ryan A. Murr, Esq.

CORRESP
1
filename1.htm

CORRESP

 Novus Therapeutics, Inc.

19900 MacArthur Blvd., Suite 550

Irvine, California 92612

 (949) 238-8090

 July 30, 2018

VIA EDGAR

 Securities and Exchange Commission

Division of Corporation Finance

 100 F Street, N.E.

Washington, DC 20549

 Attn: Irene Paik

Re:
Novus Therapeutics, Inc.

 Registration Statement on Form S-3

Filed July 23, 2018

File No. 333-226286

Ladies and Gentlemen:

 Pursuant to Rules 460
and 461 promulgated under the Securities Act of 1933, as amended, Novus Therapeutics, Inc., a Delaware corporation (the “Company”), hereby respectfully requests that the effective time of the above referenced Registration Statement on
Form S-3 filed by the Company (the “Registration Statement”) be accelerated to 4:00 p.m., Eastern Daylight Time, on, July 31, 2018 or as soon thereafter as practicable.

[Signature page follows]

Very truly yours,

Novus Therapeutics, Inc.

 /s/ Gregory J. Flesher

Gregory J. Flesher

Chief Executive Officer

cc:
 Ryan A. Murr, Gibson, Dunn & Crutcher LLP

CORRESP
1
filename1.htm

Acceleration Request

 Novus Therapeutics, Inc.

19900 MacArthur Blvd., Suite 550

Irvine, California 92612

 (949)
238-8090

 August 7, 2017

 VIA EDGAR

 Securities and Exchange Commission

 Division of
Corporation Finance

 100 F Street, N.E.

 Washington, DC 20549

 Attn: Irene Paik

Re:
Novus Therapeutics, Inc.

Registration Statement on Form S-3

Filed June 23, 2017

File No. 333-218949

 Ladies and Gentlemen:

Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, Novus Therapeutics, Inc., a Delaware corporation (the
“Company”), hereby respectfully requests that the effective time of the above referenced Registration Statement on Form S-3 filed by the Company (the “Registration Statement”) be accelerated to 4:00 p.m., Eastern Daylight Time,
on August 9, 2017 or as soon thereafter as practicable.

 Please call Ryan Murr of Gibson, Dunn & Crutcher LLP at (415) 393-8243
as soon as the Registration Statement has been declared effective.

 [Signature page follows]

Very truly yours,

Novus Therapeutics, Inc.

 /s/ Jon Kuwahara

Jon Kuwahara

Senior Vice President of Finance and Administration

cc:
Ryan A. Murr, Gibson, Dunn & Crutcher LLP

CORRESP
1
filename1.htm

CORRESP

 Ryan A. Murr

Direct: +1 415.393.8373

 Fax: +1 415.374.8430

RMurr@gibsondunn.com

 August 3, 2017

 VIA
EDGAR

 U.S. Securities and Exchange Commission

 Division
of Corporation Finance

 100 F Street, N.E.

 Washington, D.C.
20549

 Attention: Irene Paik

Re:
Novus Therapeutics, Inc.
Registration Statement on Form S-3
Filed on June 23, 2017
File No. 333-218949

Dear Ms. Paik:

 On behalf of our client, Novus
Therapeutics, Inc. (the “Company”), set forth below is the Company’s response to comments of the staff (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) contained
in the comment letter, dated June 28, 2017 (the “Comment Letter”), with respect to the above referenced Registration Statement on Form S-3 (as amended, the “S-3”). On the date hereof, the Company has filed
Amendment No. 1 to the S-3 (“Amendment No. 1”), incorporating the changes described herein. For your convenience, each comment from the Comment Letter is set forth in bold type
below.

 Selling Securityholders, page 2

1.
It appears that you intend to rely on General Instruction II.G. of Form S-3 in order to refer to unnamed selling security holders in a generic manner by identifying the initial transaction in which the securities
were sold. For example, we note your disclosure on page 3 that you will provide information about other selling security holders, except for any future transferees, pledgees, donees or successors of the selling security holder named in the selling
securityholder table, in a prospectus supplement or amendment to the registration statement. Please note that General Instruction II.G. is only available to registrants eligible to register primary offerings on Form S-3 pursuant to General
Instruction I.B.1, for which you do not appear to be eligible. Please revise your disclosure here and elsewhere to clarify that you must file a post-effective amendment to add selling security holders to your registration statement and that a Rule
424(b) prospectus supplement must be

 U.S. Securities and Exchange Commission

Attention: Irene Paik

 August 3, 2017

Page 2

used to post-effectively update the selling security holder table to reflect any transfers from a previously identified selling security holder. For guidance, please refer to Question 140.03 of
the Regulation S-K Compliance and Disclosure Interpretations.

 Response: As reflected in Amendment No. 1, the Company
revised the S-3 to clarify that the Company must file a post-effective amendment to add selling security holders to the S-3 and that a Rule 424(b) prospectus supplement must be used to post-effectively update the selling security holder table to
reflect any transfers from a previously identified selling security holder.

 Incorporation of Certain Information by Reference, page 6

2.
Please incorporate by reference your Form 8-A filed September 12, 2014, as amended on June 23, 2017. Please see Item 12(a)(3) of Form S-3 for guidance.

Response: As reflected in Amendment No. 1, the Company revised the S-3 to incorporate by reference the Company’s Registration Statement on
Form 8-A, filed on September 12, 2014, as amended by Amendment No. 1 to the Registration Statement on Form 8-A, filed on June 23, 2017.

If we can be of any further assistance, or if you have any questions regarding this letter, please do not hesitate to call me at (415) 393-8373.

 Very truly yours,

/s/ Ryan Murr

 Ryan Murr

cc: Gregory Flesher, Chief Executive Officer, Novus Therapeutics, Inc.

June 28, 2017
Gregory  Flesher
President and Chief Executive Officer
Novus Therapeutics, Inc.
19900 MacArthur Blvd., Suite 550
Irvine, CA 92612
Novus Therapeutics, Inc.
Registration Statement on Form S-3
Filed on June 23, 2017
File No. 333-218949Re:
Dear Mr. Flesher:
        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.  If 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.

Gregory  Flesher
Novus Therapeutics, Inc.
2 PageJune 28, 2017
Form S-3 filed June 23, 2017
Selling Securityholders, page 2
It appears that you intend to rely on General Instruction II.G. of Form S-3 in order to refer
to unnamed selling security holders in a generic manner by identifying the initial
transaction in which the securities were sold.  For example, we note your disclosure on
page 3 that you will provide information about other selling security holders, except for
any future transferees, pledgees, donees or successors of the selling security holder named
in the selling securityholder table, in a prospectus supplement or amendment to the
registration statement.  Please note that General Instruction II.G. is only available to
registrants eligible to register primary offerings on Form S-3 pursuant to General
Instruction I.B.1, for which you do not appear to be eligible.  Please revise your
disclosure here and elsewhere to clarify that you must file a post-effective amendment to
add selling security holders to your registration statement and that a Rule 424(b)
prospectus supplement must be used to post-effectively update the selling security holder
table to reflect any transfers from a previously identified selling security holder.  For
guidance, please refer to Question 140.03 of the Regulation S-K Compliance and
Disclosure Interpretations. 1.
Incorporation of Certain Information by Reference, page 6
Please incorporate by reference your Form 8-A filed September 12, 2014, as amended on
June 23, 2017. Please see Item 12(a)(3) of Form S-3 for guidance.2.
        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.
        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 Irene Paik at (202) 551-6553 with any questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Ryan Murr, Esq., Gibson, Dunn & Crutcher LLP

Mail Stop 4546

 March 31, 2017

Jodie P. Morrison
President and Chief Executive Officer
Tokai Pharmaceuticals, Inc.
255 State Street, 6th Floor
Boston, Massachusetts 02109

Re: Tokai  Pharmaceuticals, Inc.
 Preliminary Proxy Statement on Schedule 14A
Filed January 24, 2017
  File No. 001 -36620

Dear  Ms. Morrison :

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 the ir disclosure s, notwithstanding
any review, comments, action or absence  of action  by the staff .

Sincerely,

 /s/ Suzanne Hayes

Suzanne Hayes
Assistant Director
Office of Healthcare and Insurance

cc: Stuart M. Falber, Esq.
 Wilmer Cutler Pickering Hale and Dorr LLP

Mail Stop 4546

 March  23, 2017

Jodie P. Morrison
President and Chief Executive Officer
Tokai Pharmaceuticals, Inc.
255 State Street, 6th Floor
Boston, Massachusetts 02109

Re: Tokai  Pharmaceuticals, Inc.
 Amendment No. 1 to
 Preliminary Proxy Statement on Schedule 14A
Filed March 9 , 2017
  File No. 001 -36620

Dear Ms. Morrison :

We have reviewed your response dated March  9, 2017 and the above referenced 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.  Unless we note otherwi se, our reference to prior comments are to comments in our
February 23 , 201 7 letter.

Public Company Market Valuation Analysis -Otic, page 90

1. We note your response to prior comment 15.  Please revise your Summary and Business
section to prominently highlight that you are no longer developing OP -01 in its original
form and the first generation product compound has now been modified and has been
pursued by Otic as a second generation compound that is currently in preclinical
development.  Additionally,  clarify whether you will be required to perform additional
phase 1 trials and to what extent you can rely on clinical trials for the original form.

Jodie P. Morrison
Tokai Pharmaceuticals, Inc.
March  23, 2017
Page 2

 Pipeline Chart, page 136

2. Your chart currently indicates that OP -01 has completed phase 2 trials; add itional
formulation work is necessary and you will be required to repeat early development.
Please explain why it is appropriate to include a chart indicating that Phase 2 testing of
OP-01 is complete given that you will need to perform new preclinical an d/or Phase 1
clinical trials for the second generation compound.  Please revise the footnote to clearly
explain which development stages you will need to repeat.  If you believe that you will
not have to perform Phase 1 trials of the second generation comp ound, please tell us the
basis for your belief.

Index to Otic Consolidated Financial Statements
Notes to the Consolidated Financial Statements
Note 2. Summary of Significant Accounting Policies
Recent Accounting Pronouncements, page F -40

3. Your disclosure of ASU 2014 -09 states that the original effective date of this guidance
for public entities was for annual reporting periods beginning after December 15,
2016.   Please revise your disclosure similar to the disclosure you included on page F -49
of the original filing, since the effective date for this standard is January 1, 2018.   Please
also include the expected impact similar to your previous disclosure.

You may contact Vanessa Robertson at (202) 551 -3649 or Angela Connell at (202) 551 -
3426 if you have questions regarding comments on the financial statements and related matters.
Please contact Jeffrey Gabor at (202) 551 -2544 or Suzanne Hayes at (202) 551 -3675 with any
other questions.

Sincerely,

 /s/ Suzanne Hayes

Suzanne Hayes
Assistant Director
Offic e of Healthcare and Insurance

cc: Stuart M. Falber, Esq.
 Wilmer Cutler Pickering Hale and Dorr LLP

Mail Stop 4546

 February 23, 2017

Jodie P. Morrison
President and Chief Executive Officer
Tokai Pharmaceuticals, Inc.
255 State Street, 6th Floor
Boston, Massachusetts 02109

Re: Tokai Pharmaceuticals, Inc.
 Preliminary Proxy Statement on Schedule 14A
Filed January 24, 2017
  File No. 001 -36620

Dear Ms. Morrison :

We have reviewed your filing an d 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 busine ss days by providing the requested
information or advis e 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.

General

1. Please include a statement as to whether or not re presentatives of the principal
accountants for the current year and the most recently completed fiscal year are expected
to be present, will have the opportunity to make a statement if they desire to do so, and
are available to respond to appropriate quest ions. Please refer to Item 13(a)(6) of
Schedule 14A.

2. Please revise your proxy statement and proxy card to allow for separate voting on the
Tokai share issuances in the merger transaction and pursuant to the Tokai Stock Purchase
Agreement.  You may condit ion the completion of the transaction on shareholder
approval of the separate proposals.

Jodie P. Morrison
Tokai Pharmaceuticals, Inc.
February 23, 2017
Page 2

 Summary, page 1

3. Please revise “The Transaction Structure” to describe the Tokai Stock Purchase
agreement and disclose the impact of the Tokai Stock Purchase and O tic share and
warrant exercises will have on the expected percentage ownership of the combined
company.

4. Please tell us the factors you considered in determining that the issuances of Tokai
common stock are exempt pursuant to Section 4(a)(2), Regulation D or Regulation S.

5. Please revise “Conditions to the Consummation of the Otic Transaction” to identify
conditions that the parties may waive.

Risk Factors, page 29

The combined company’s common stock could be delisted from NASDAQ if Tokai and Otic fail
to comply with NASDAQ’s listing standards, page 31

6. If the listing approval is a condition that can be waived, please revise the caption and
discussion to clarify that the consequences also apply if the combined company fails to
obtain NASDAQ listing but deci des to complete the transaction.

7. Please also disclose the possible decrease in share price your common stock is delisted.

The success of the combined company will also depend on the pre -existing relationships with
third parties…, page 60

8. Please identify  any material relationships or agreements that are likely to be affected by
the Otic transaction, describe the nature of the relationship and the potential
consequences if the transaction results in the cancellation of a material agreement or
negative impa ct on a relationship with a third party.

Background of the Otic Transaction, page 71

9. Please expand this section to identify the parties present at each Tokai meeting related the
proposed transaction and potential alternatives.  Additionally, identify ea ch of the parties
present at each meeting between Tokai and Otic.

10. Please expand your discussion to clarify the reasons the Board did not pursue the
strategic alternatives they reviewed on July 28, 2016, including continuing development,
licensing or oth erwise monetizing galeterone, and winding up the operations and
distributing net cash to Tokai shareholders in liquidation.

Jodie P. Morrison
Tokai Pharmaceuticals, Inc.
February 23, 2017
Page 3

 11. We note that you met with 40 companies; sent draft process letters to 30 companies;
provided draft merger agreements to ten out o f 24 companies that submitted non -binding
indications of interest; and entered into negotiations with three of the four companies that
submitted revised drafts of the draft merger agreement.  Please expand your discussion to
clarify the criteria you used t o eliminate companies from consideration.

12. Please revise your disclosure throughout this section to provide greater detail as to the
background of the transaction, including the material issues discussed and key negotiated
terms. The disclosure should provide shareholders with an understanding of how, when,
and why the material terms of your proposed transaction evolved and why this
transaction is being recommended as opposed to any alternatives. In your revised
disclosure, please ensure that you addres s the following:

 the material terms in the initial proposal and subsequent proposals by Otic,
Company A, B, & C;

 the consideration involved in the competing offers;

 the Board’s basis for approving the Otic transaction over competing offers; and

 at what  point Companies A, B and C were eliminated from consideration.

13. Please provide us with copies of the materials that Wedbush prepared and shared with the
board of directors or the transaction committee in connection with this transaction,
including any boa rd books, transcripts and summaries of oral presentations made. We
may have additional comments after we review those materials.

Vesting of Director Stock Options, page 84

14. Please expand this discussion to disclose the number options held by each officer  and
director that will vest upon the closing of this transaction.

Public Company Market Valuation Analysis -Otic, page 90

15. We note that Wedbush reviewed publicly -traded companies with no product candidates
beyond Phase 1 or Phase 1/2 and no human efficacy  data.  Please expand your discussion
to clarify why Wedbush considered these criteria appropriate to select companies similar
to Otic given that Otic has completed Phase 2 trials and has human efficacy data related
to OP -01.

16. Please clarify whether the companies identified as similar to Otic were the only public
companies that met the selection criteria.  If there were others, please clarify why they
were not included in the analysis.  Similarly, tell us whether there were other precedent
merger and acqu isitions transactions and initial public offerings that met the selection

Jodie P. Morrison
Tokai Pharmaceuticals, Inc.
February 23, 2017
Page 4

 criteria described in “Precedent Merger and Acquisition Transaction Analysis – Otic” and
“Precedent Initial Public Offering Analysis – Otic” and clarify why any such transactions
were not included in the analysis, if applicable.

Otic’s Business, page 127

17. We refer to your statement that Otic has completed four clinical trials of OP -01 in 353
subjects, including a successful phase 2b study. Please revise to discuss where these trials
have been conducted.

Otic’s Management’s Discussion and Analysis of Financial Condition and Results of Operations
Research and Development Expenses, page 155

18. Please tell us how costs associated with obtaining and maintaining Otic’s patent portfolio
meet the definition of research and development expenses in ASC 730 -10 as these costs
appear to be the same or similar to activities described in ASC 730 -10-55-2.i., which are
not generally considered research and development.   Please also quantify for us the
amount of any patent -related costs included within research and development expenses
for the periods presented.

Security Ownership of Certain Beneficial Owners and Management of Tokai, page 169

19. Please expand to disclose the post -transaction beneficia l ownership of the registrant,
particularly given the first risk factor on page 31.

Index to Otic Consolidated Financial Statements
Notes to the Consolidated Financial Statements
Note 7 - Commitments and Contingencies
C. License Agreement, page F -51

20. Please revise your disclosure to quantify the amount of potential future development and
regulatory milestone payments in connection with the license agreement.

We remind you that the company and its management are responsible for the accuracy
and adequac y of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.

Jodie P. Morrison
Tokai Pharmaceuticals, Inc.
February 23, 2017
Page 5

 You may contact Vanessa Robertson at (202) 551 -3649 or Angela Connell at (202) 551 -
3426 if you have questions regarding comments on the financi al statements and related matters.
Please contact Jeffrey Gabor at (202) 551 -2544 or Suzanne Hayes at (202) 551 -3675 with any
other questions.

Sincerely,

 /s/ Suzanne Hayes

Suzanne Hayes
Assistant Director
Office of Healthcare and Insurance

cc: Stuart M. Falber, Esq.
 Wilmer Cutler Pickering Hale and Dorr LLP

CORRESP
1
filename1.htm

S-3 - Acceleration Request

 TOKAI PHARMACEUTICALS, INC.

255 State Street, 6th floor

Boston, Massachusetts 02109

 October 21,
2015

 Via EDGAR

 Securities and Exchange Commission

 Division of Corporation Finance

 100 F Street, N.E.

Washington, D.C. 20549

Re:
Tokai Pharmaceuticals, Inc.

 Registration Statement on Form S-3

File No. 333-207359

 Request
for Acceleration

 Ladies and Gentlemen:

 Pursuant to
Rule 461 promulgated under the Securities Act of 1933, as amended, Tokai Pharmaceuticals, Inc. (the “Registrant”) hereby requests acceleration of the effective date of its Registration Statement on Form S-3 (File No.
333-207359) (the “Registration Statement”), so that it may become effective at 4:00 p.m. Eastern time on October 23, 2015, or as soon thereafter as practicable.

The Registrant hereby acknowledges that:

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

(b)
the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the Registration Statement effective, does not relieve the Registrant from its full responsibility for the adequacy and
accuracy of the disclosure in the Registration Statement; and

(c)
the Registrant may not assert staff comments and the declaration of effectiveness of the Registration Statement as a defense in any proceeding initiated by the Commission or any person under the federal securities laws
of the United States.

 [The remainder of this page is intentionally left blank.]

Very truly yours,

TOKAI PHARMACEUTICALS, INC.

By:

 /s/ Jodie Morrison

Name:

Jodie P. Morrison

Title:

President and Chief Executive Officer

 [Signature Page to Request for Acceleration]

Mail Stop 4720

October 20 , 2015

Via E -mail
Jodie P. Morrison
President and Chief Executive Officer
Tokai Pharmaceuticals, Inc.
255 State Street, 6th floor
Boston, Massachusetts 02109

Re: Tokai Pharmaceuticals, Inc .
  Registration Statement  on Form S -3
Filed  October 9, 2015
  File No.  333-207359

Dear Ms. Morrison ,

This is to advise you that we have not  reviewed and will not review your 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 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 disclosure, they are responsible for the accuracy
and adequacy of the disclosures they have made.

In the event you request acceleration of the effective date of the pending regist ration
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 wit h 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 th e 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.

Jodie P. Morrison
Tokai Pharmaceuticals, Inc.
October 20 , 2015
Page 2

 Please refer to Rules 460 and 4 61 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 u nder
the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed
public offering of the registered securities .

 Please  contact Alla Berenshteyn  at (202) 551 -4325 or me at (202) 551 -3675  with any
questions.

Sincerely,

 /s/ Suzanne Hayes

Suzanne Hayes
Assistant Director
Office of Healthcare and Insurance

cc: Via E -mail
 Stuart M. Falber , Esq.
 Wilmer Cutler Pickering Hale and Dorr  LLP

CORRESP
1
filename1.htm

Correspondence

 TOKAI PHARMACEUTICALS, INC.

One Broadway, 14th floor

Cambridge, MA 02142

 September 12, 2014

VIA EDGAR

 Securities and Exchange Commission

 Division of Corporation Finance

 100 F Street, N.E.

Washington, D.C. 20549

Re:
Tokai Pharmaceuticals, Inc.

 Registration Statement on Form S-1

File No. 333-198052

Request for Acceleration

 Ladies and
Gentlemen:

 Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, Tokai Pharmaceuticals, Inc. (the
“Registrant”) hereby requests acceleration of the effective date of its Registration Statement on Form S-1 (File No. 333-196932), as amended (the “Registration Statement”), so that it may become effective at 4:30 p.m.
Eastern time on September 16, 2014, or as soon thereafter as practicable.

 The Registrant hereby acknowledges that:

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

(b)
the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the Registration Statement effective, does not relieve the Registrant from its full responsibility for the adequacy and
accuracy of the disclosure in the Registration Statement; and

(c)
the Registrant may not assert staff comments and the declaration of effectiveness of the Registration Statement as a defense in any proceeding initiated by the Commission or any person under the federal securities laws
of the United States.

 [The remainder of this page is intentionally left blank.]

 Very truly yours,

TOKAI PHARMACEUTICALS, INC.

By:

/s/ Jodie P. Morrison

Name:

Jodie P. Morrison

Title:

President and Chief Executive Officer

 [Signature Page to Request for Acceleration]

CORRESP
1
filename1.htm

Correspondence

 September 12, 2014

Via EDGAR

 Securities and Exchange Commission

 Division of Corporation Finance

 100 F Street, NE

Washington, D.C. 20549

 Attention:
        Jeffrey P. Riedler, Assistant Director

 Re:     Tokai Pharmaceutical, Inc.
Registration Statement on Form S-1 (No. 333-198052)

 Ladies and Gentlemen:

Pursuant to Rule 461 of the Securities Act of 1933, as amended (the “Act”), BMO Capital Markets Corp., Stifel, Nicolaus &
Company, Incorporated, and William Blair & Company, L.L.C., as representatives of the several underwriters, hereby join Tokai Pharmaceuticals, Inc., in requesting that the effective date for the Registration Statement referred to above be
accelerated so that it will be declared effective at 4:30 p.m. Eastern time on September 16, 2014, or as soon thereafter as possible.

Pursuant to Rule 460 under the Act, we wish to advise you that we have distributed approximately 2,505 copies of the Preliminary Prospectus
dated September 2, 2014 (the “Preliminary Prospectus”) through the date hereof to underwriters, dealers, institutions and others.

This is to further advise you that the underwriters have complied and will continue to comply with Rule 15c2-8 under the Securities Exchange
Act of 1934, as amended, in connection with the above-referenced Preliminary Prospectus.

 Very truly yours,

BMO Capital Markets Corp.

By:

/s/ Lori Begley

Name: Lori Begley

Title:   Managing Director

Stifel, Nicolaus & Company, Incorporated

By:

/s/ Keith Lister

Name: Keith Lister

Title:   Managing Director

William Blair & Company, L.L.C.

By:

/s/ Brett Paschke

Name: Brett Paschke

Title:   Head of ECM

 [Signature Page to Underwriters’ Acceleration Request]

CORRESP
1
filename1.htm

CORRESP

 FOIA CONFIDENTIAL TREATMENT REQUEST

 Stuart M. Falber

+1 617 526 6663 (t)

The entity requesting confidential treatment is:

+1 617 526 5000 (f)

 Tokai Pharmaceuticals, Inc.

 One Broadway, 14th floor

Cambridge, MA 02142

 Attn: Jodie P.
Morrison

 President and Chief Executive Officer

 (617) 225-4305

stuart.falber@wilmerhale.com

 August 25, 2014

 VIA EDGAR SUBMISSION

 Securities and Exchange Commission

Division of Corporation Finance

 100 F Street,
NE

 Washington, DC 20549

 Attention:
Johnny Gharib

Re:

Tokai Pharmaceuticals, Inc.

Registration Statement on Form S-1

File No. 333-198052

 Ladies and Gentlemen:

 In connection with the filing by Tokai Pharmaceuticals, Inc. (the “Company”) on August 11, 2014 of the above-referenced Registration Statement on Form S-1 (File No. 333-198052) (the
“Registration Statement”), on behalf of the Company, we are providing the staff (the “Staff”) of the Securities and Exchange Commission with further information for the Staff’s consideration regarding the anticipated price
range for the Company’s initial public offering.

 The responses set forth below are based upon information provided to Wilmer Cutler
Pickering Hale and Dorr LLP by the Company.

 Rule 83 Confidential Treatment Request by Tokai Pharmaceuticals, Inc. Request #1

 The Company supplementally advises the Staff that the Company currently anticipates that the price range for this offering will be within
the range of $[**] to $[**] per share (before giving effect to a reverse stock split that the Company plans to implement prior to effectiveness of the Registration Statement). This anticipated price range is based on a number of factors, including
the Company’s future prospects and those of the Company’s industry in general, the Company’s financial and operating information in recent periods, the market prices of securities of

 Securities and Exchange Commission

 August 25, 2014

  Page
 2

companies engaged in activities similar to the Company’s, existing conditions in the public capital markets and preliminary discussions with the underwriters regarding potential valuations
of the Company. The actual price range to be included in a subsequent amendment to the Registration Statement (which will comply with the Staff’s interpretation regarding the parameters of a bona fide price range) has not yet been determined
and remains subject to adjustment based on factors outside of the Company’s control. However, the Company believes that the foregoing indicative price range will not be subject to significant change.

The anticipated price range for the offering was determined with reference to several quantitative and qualitative factors, each of which contributed to
the difference between the Company’s most recent valuation of its common stock on April 8, 2014 of $0.62 per share and the midpoint of the anticipated offering price range of $[**] per share. Specifically, the Company believes that the
difference between the fair value of its common stock as of April 8, 2014 and the midpoint of the anticipated price range for this offering is primarily the result of the following factors:

Tokai Pharmaceuticals, Inc. respectfully requests that the information contained in the response be treated as confidential
information and that the Commission provide timely notice to Jodie P. Morrison, President and Chief Executive Officer, Tokai Pharmaceuticals, Inc., One Broadway, 14th floor, Cambridge, MA 02142, (617) 225-4305, before it permits any disclosure of the bracketed information in Request #1.

•

 The anticipated price range for this offering is based only upon a scenario in which the Company completes this offering and is not probability
weighted, in contrast to the Company’s prior valuations of common stock, which had to consider multiple potential outcomes, some of which would have resulted in a lower value of its common stock than an initial public offering
(“IPO”).

•

 The anticipated price range for this offering necessarily assumes that the IPO has occurred and that a public market for the Company’s common
stock has been created and, therefore, excludes any discount for lack of marketability of its common stock, which was appropriately taken into account in the Company’s determination of fair value of its common stock on April 8, 2014.

•

 The Company’s preferred stock currently has substantial economic rights, preferences and privileges over its common stock. Upon the closing of
this offering, all outstanding shares of the Company’s preferred stock will convert into common stock, thus eliminating the superior rights, preferences and privileges of the Company’s preferred stock as compared to its common stock.

•

 In May 2014, the Company announced interim data from its ongoing Phase 2 clinical trial of galeterone (the “ARMOR2 trial”) at The American
Society of Clinical

 Securities and Exchange Commission

 August 25, 2014

  Page
 3

Oncology 2014 Annual Meeting (“ASCO”). Specifically, the Company reported positive interim safety and efficacy results, including that (i) in 51 evaluable castration resistant
prostate cancer (“CRPC”) treatment-naïve patients in the ARMOR2 trial, galeterone showed clinically meaningful reductions in levels of prostate specific antigen (“PSA”), a biochemical marker used to evaluate prostate cancer
patients for signs of response to therapy and (ii) all four patients in the ARMOR2 trial who were identified as having truncated androgen receptors with C-terminal loss had maximal reductions in PSA levels of at least 50%.

•

 Data presented at ASCO by researchers at MD Anderson Cancer Center (“MD Anderson”) and Johns Hopkins University (“Johns
Hopkins”) showed that the presence in patients of truncated androgen receptors with C-terminal loss and AR-V7 was associated with poor responsiveness to treatment with Zytiga and Xtandi, two of the highest selling therapies for CRPC. The
Company believes that these studies indicate that there is a need for effective treatments for CRPC patients with truncated androgen receptors. As a result, following ASCO, the Company determined that it would focus its initial development of
galeterone on the treatment of patients with CRPC whose prostate tumor cells expressed an altered androgen receptor. This decision was based on the MD Anderson and Johns Hopkins data, as well as positive clinical data observed in the ARMOR2
trial in patients with C-terminal loss and preclinical data summarized in the Registration Statement. In particular, the Company plans to initiate a pivotal clinical trial in patients with C-terminal loss generally or AR-V7 specifically (as described in the Registration Statement).

•

 The proceeds of a successful IPO would substantially strengthen the Company’s balance sheet by increasing its cash resources. In addition, the
closing of this offering would provide the Company with readier access to the public company debt and equity markets. These projected improvements in the Company’s financial position influenced the increased common stock valuation indicated by
the midpoint of the anticipated price range.

 The Company respectfully requests confidential treatment under 17 C.F.R.
§ 200.83 for the contents of this letter and has submitted a separate request for confidential treatment in accordance therewith to the Commission’s Office of Freedom of Information and Privacy Act Operations.

*        *        *

If you have any further questions or comments, or if you require any additional information, please contact the undersigned by telephone at
(617) 526-6663. Thank you for your assistance.

 Securities and Exchange Commission

 August 25, 2014

  Page
 4

 Very truly yours,

/s/ Stuart M. Falber

Stuart M. Falber

cc:

Jodie P. Morrison

Daniel Greenspan, Securities and Exchange Commission

Jim Peklenk, Securities and Exchange Commission

Office of Freedom of Information and Privacy Act Operations

Securities and Exchange Commission

100 F Street N.E., Mail Stop 2736

Washington, D.C. 20549

May 29, 2014

Via E -Mail
Jodie P. Morrison
President and Chief Executive Officer
Tokai Pharmaceuticals, Inc.
One Broadway, 14th floor
Cambridge, MA 02142

Re: Tokai  Pharmaceuticals , Inc.
Confidential Draft Registration Statement on Form S -1
Submitted May 2, 2014
  CIK No. 0001404281

Dear Ms. Morrison :

We have reviewed your confidential draft registration statement  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 this letter by providing the requested information and either submitting
an amended confidential draft registration statement or publicly filing your registration statement
on EDGAR.  If 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 the information you provide in response to these  comments  and your
amended confidential draft registration statement or f iled registration statement,  we may have
additional comments.

General

1. If our comments are applicable to portions of the filings that we have not cited, please
make the appropriate changes elsewhere in the filing in accordance with our comments.

2. Please  submit all exhibits as soon as practicable. We may have further comments  upon
examination of these exhibits .

3. Please confirm that the graphics included in your registration statement are the only
graphic, visual, or photographic information you will use i n your prospectus. If those are
not the only graphics, please provide any additional graphics prior to their use for our
review.

Jodie P. Morrison
Tokai Pharmaceuticals, Inc.
May 29 , 2014
Page 2

 4. Please supplementally provide us with copies of all written communications, as defined
in Rule 405 under the Securities Act, t hat you, or anyone authorized to do so on your
behalf, present to potential investors in reliance on Section 5(d) of the Securities Act,
whether or not they retain copies of the communications. Similarly, please
supplementally provide us with any research reports about you that are published or
distributed in reliance upon Section 2(a)(3) of the Securities Act of 1933 added by
Section 105(a) of the Jumpstart Our Business Startups Act by any broker or dealer that is
participating or will participate in your offering.

5. We note that you have submitted a request for confidential treatment of portions of
certain of your exhibits.  We will provide any comments on your confidential treatment
request and the related disclosure in a separate comment letter.

6. Please amend your filing to include updated financial statements meeting the
requirements of Regulation S -X, as well as any financial information required by
Rule 8 -04 and 8 -05 of Regulation S -X.

Risk Factors
“If serious adverse or unforeseen side effects are identified  …” page 16

7. Please expand  this risk factor to disclose the nature and amount o f any serious
treatment -related side effects reported in your clinical trials to date  and whether
you have experienced interruptions or delays as a result of such adverse events .

“We will incur increased costs as a result of operating as a public company…” page 39

8. Please expand  this risk factor to include an estimate of the annual costs you expect to
incur as public company .

Use of Proceeds, page 44

9. Please revise your disclosure to identify the financial advisor to which you will pay a
portion of the proceeds and briefly des cribe the services rendered .  In the Business
section , please describe any ongoing material terms of your agreement with such advisor.
In addition, please file a copy of your agreement with this advisor as an exhibit to your
registration statement pursuan t to Item 601 of Regulation S -K.

Business , page 68

10. In this section and in the Prospectus Summary, please briefly disclose the significance of
fast track FDA review.

11. Please revise your disclosure to specify when, and the indication for which, you
submitted any INDs in connection with your clinical trials of galeterone .  If you  have

Jodie P. Morrison
Tokai Pharmaceuticals, Inc.
May 29 , 2014
Page 3

 conducted clinical trials for which you did not submit a corresponding IND, please tell us
why.

Galeterone Clinical Development
ARMOR2 Trial
Clinical Trial Presented at ASCO GU, page  76

12. In addition the inte rim efficacy data provided,  please advise us and disclose, if
applicable, whether there were any interim data available for the other patient
populations you identify on page 75.

Reformulation of Galeterone, page 78

13. Please expand your d isclosure to explain what you mean by a “spray dried dispersion
formulation” and how it is administered.

Intellectual Property
Galeterone Patent Portfolio, page 85

14. Please explain what a provisional patent application is and disclose the foreign
jurisdicti ons associated with your patents and patent applications.

License Agreement with University of Maryland , page 8 7

15. Please disclose the expiration date of the license with UMB  or, if applicable, state that it
is perpetual unless terminated in accordance with its terms.

Employment Agreements, Severance and Change in Control Agreements, page 109

16. Please disclose the material terms of  each of the employment agreements with Mr.
McBride and Dr. Ferrante  and file these agreements  pursuant  to Item 601(b)(10) of
Regulation S -K.

If you intend to respond to these comments with an amended draft registration statement ,
please submit it and any associated correspondence in accordance with the guidance we provide
in the Division’s October 11, 2012 announcement on the SEC website at
http://www.sec.gov/divisions/corpfin/cfannouncements/drsfilingprocedures101512.htm .

Please keep in mind that we may publicly post filing revie w correspondence in
accordance with our December 1, 2011 policy
(http://www.sec.gov/divisions/corpfin/cfannouncements/edgarcorrespondence.htm ).  If you
intend to use Rule 83 (17 CFR 200.83) to request confidential treatment of information in the
correspond ence you submit on EDGAR, please properly mark that information in each of your

Jodie P. Morrison
Tokai Pharmaceuticals, Inc.
May 29 , 2014
Page 4

 confidential submissions to us so we do not repeat or refer to that information in our comment
letters to you.

You may contact  Jim Peklenk at (202) 551 -3661 or Andrew Mew at  (202) 551 -3377 if
you have questions regarding comments on the financial statements and related matters.  Please
contact Amy Reischauer  at (202) 551 -3793, Daniel Greenspan at (202) 551 -3623 or me at (202)
551-3715  with any other questions.

Sincerely,

 /s/ Daniel  Greenspan for

Jeffrey P. Riedler
Assistant Director

cc: Via E -Mail
Stuart M. Falber
Wilmer  Cutler Pickering Hale and Dorr LLP
60 State Street
Boston, MA 02109