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SEC Comment Letter for Hepion Pharmaceuticals, Inc. (HEPA, CTRVP) (CIK 0001583771) (HEPA) — Nov 4, 2013

Hepion Pharmaceuticals, Inc. (HEPA, CTRVP) (CIK 0001583771)
Date: Nov. 4, 2013 · CIK: 0001583771 · Accession: 0000000000-13-060562

AI Filing Summary & Sentiment

Date
October 22, 2013
Author
/s/ Daniel Greenspan for
Form
UPLOAD
Company
Hepion Pharmaceuticals, Inc. (HEPA, CTRVP) (CIK 0001583771)

Letter

November 4 , 2013 Via E -Mail Bernard F. Denoyer Senior Vice President, Finance Synergy Pharmaceuticals Inc. 420 Lexington Avenue Suite 2012 New York, NY 10170

Re: ContraVir Pharmaceuticals, Inc. Amendment No. 2 to Form 10 Filed October 22, 2013 File No. 000 -55020

Dear Mr. Denoyer:

We have reviewed your amended 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 this letter within ten business days by amending your filing, by providing the requested information, or by advising us when you will provide the requested response. 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 filing and the information you provide in response to these comments, w e may have additional comments.

Business, page 43

FV-100, page 44

1. We note your response to our prior Comment 5. Please expand your disclosure to include the maximum total milestone payments you could potentially owe to Bristol -Meyers Squibb Company (B MS), a description of the potential royalties within 10%, such as single -digits, teens, twenties, etc., and the termination provisions of your Asset Purchase Agreement with BMS.

2. We note your response to our prior Comment 6. Please disclose whether “numeri cally favorable treatment difference” or “relative treatment difference” are standards recognized by the FDA or any comparable regulatory agency.

Bernard F. Denoyer ContraVir Pharmaceuticals, Inc. November 4, 2013 Page 2

3. We note your response to our prior Comment 10. Please define the following abbreviations used in the tables o n page 47:

 “S.E.;”  “AE;” and  “SAE.”

Intellectual Property, page 48

4. We note your response to our prior Comment 11. Please revise your disclosure to state clearly whether your foreign granted patents related to FV -100 are licensed or owned. If licensed, pl ease identify the licensor.

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 Exchange Act of 1934 and all applicable Exchange Act rules require. Since the compa ny 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 responding to our comments, please provide a written statement from the com pany 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 t o 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.

Bernard F. Denoyer ContraVir Pharmaceuticals, Inc. November 4, 2013 Page 3

Please contact Christina De Rosa at (202) 551 -3577, Dan Greenspa n at (202) 551 -3623 or me at (202) 551 -3710 with any questions.

Sincerely,
/s/ Daniel Greenspan for

Show Raw Text
November 4 , 2013

Via E -Mail
Bernard F. Denoyer
Senior Vice President, Finance
Synergy Pharmaceuticals Inc.
420 Lexington Avenue
Suite 2012
New York, NY 10170

Re: ContraVir  Pharmaceuticals, Inc.
 Amendment No. 2 to Form 10
Filed October 22, 2013
File No. 000 -55020

Dear Mr. Denoyer:

We have reviewed your amended 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 this letter within ten business days by amending your filing, by
providing the requested information, or by advising us when you will provide the requested
response.   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 filing and the information you provide in
response to these comments, w e may have additional comments.

Business, page 43

FV-100, page 44

1. We note your response to our prior Comment 5. Please expand your disclosure to include
the maximum total milestone payments you could potentially owe to Bristol -Meyers
Squibb Company (B MS), a description of the potential royalties within 10%, such as
single -digits, teens, twenties, etc., and the termination provisions of your Asset Purchase
Agreement with BMS.

2. We note your response to our prior Comment 6. Please disclose whether “numeri cally
favorable treatment difference” or “relative treatment difference” are standards
recognized by the FDA or any comparable regulatory agency.

Bernard F. Denoyer
ContraVir Pharmaceuticals, Inc.
November 4, 2013
Page 2

 3. We note your response to our prior Comment 10. Please  define the following
abbreviations used in the tables o n page 47:

 “S.E.;”
 “AE;” and
 “SAE.”

Intellectual Property, page 48

4. We note  your response to our prior Comment 11. Please revise your disclosure to state
clearly whether your foreign granted patents related to FV -100 are licensed or owned. If
licensed, pl ease identify the licensor.

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 Exchange Act of
1934 and all applicable Exchange Act rules require.   Since the compa ny 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 responding to our comments, please provide a written statement from the com pany
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 t o 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.

Bernard F. Denoyer
ContraVir Pharmaceuticals, Inc.
November 4, 2013
Page 3

Please contact Christina De Rosa at (202) 551 -3577, Dan Greenspa n at (202) 551 -3623 or
me at (202) 551 -3710 with any questions.

Sincerely,

 /s/ Daniel  Greenspan  for

 Jeffrey P. Riedler
Assistant Director
cc: Via E -mail
 Jeffrey Fessler
 Sichenzia Ross Friedman Ference LLP
 61 Broadway, 32nd Floor
New York, NY  10006