SEC Comment Letter for PDS Biotechnology Corp (PDSB) (CIK 0001472091) (PDSB) — Jun 6, 2014
PDS Biotechnology Corp (PDSB) (CIK 0001472091)
Date: June 6, 2014 · CIK: 0001472091 · Accession: 0000000000-14-028926
AI Filing Summary & Sentiment
Reasoning
Letter
June 6 , 2014 Via E -mail Brian A. Leuthner President and Chief Executive Officer Edge Therapeutics, Inc. 200 Connell Drive, Suite 1600 Berkeley Heights, NJ 07922
Re: Edge Therapeutics, Inc. Amendment No. 1 to Draft Registration Statement on Form S -1 Submitted May 19 , 2014 CIK No. 0001472091
Dear Mr. Leuthner:
We have reviewed your amended draft registration statement and have the following additional comments. In some of our comments, we may ask you to provide us with infor mation so we may better understand your disclosure.
Please respond to this letter by providing the requested infor mation and either sub mitting an amended confidential draft re gistration state ment or publicly filing your registration state ment on EDGAR. If you do not believe our comments apply to your facts and circu mstances or do not believe an amendment is a ppropriate, please tell us why in your response.
After revie wing the infor mation you provide in response to these com ments and your amended confidential draft registration state ment or filed registration state ment, we may have additio nal co mments.
Clinical Results, pages 69 -71
1. We note your revised disclosure reporting datasets and observations from the first completed cohort of the NEWTON trial and the dataset from patients who received EG - 1962 at HHU Medical Center. In particular, we note your references as to both datasets regarding “favorable outcomes.” Please clarify your disclosure throughout this section to quantify your results, explain how you are measuring them, and disclose your criteria for considering an outcome favorable.
2. We note your response to our prior comme nt 12 and your expanded disclosure on page 70 regarding ITAs. Given that there are no standardized enrollment criteria and there is no need for regulatory approval prior to conducting the ITAs, please disclose here the extent to which you may rely on the results of the ITA in future regulatory filings with the FDA.
Brian A. Leuthner Edge Therapeutics, Inc. June 6 , 2014 Page 2
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 review 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 correspondence you submit on EDGAR, please properly mark that information in each of your confidential submissions to us so we do not repeat or refer to that information in our comment letters to you.
You may contact Christine Torney at (202) 551 -3652 or Mary Mast at (202) 551 -3613 if you have questions regarding comments on the financial statements and related matters. Please contact Austin Stephenson at (202) 551 -3192, Dan Greenspan at (202) 551 -3623, or me at (202) 551-3715 with any other questions.
Sincerely,
/s/ Daniel Greenspan for
Show Raw Text
June 6 , 2014
Via E -mail
Brian A. Leuthner
President and Chief Executive Officer
Edge Therapeutics, Inc.
200 Connell Drive, Suite 1600
Berkeley Heights, NJ 07922
Re: Edge Therapeutics, Inc.
Amendment No. 1 to Draft Registration Statement on Form S -1
Submitted May 19 , 2014
CIK No. 0001472091
Dear Mr. Leuthner:
We have reviewed your amended draft registration statement and have the following
additional comments. In some of our comments, we may ask you to provide us with infor mation
so we may better understand your disclosure.
Please respond to this letter by providing the requested infor mation and either sub mitting
an amended confidential draft re gistration state ment or publicly filing your registration state ment
on EDGAR. If you do not believe our comments apply to your facts and circu mstances or do
not believe an amendment is a ppropriate, please tell us why in your response.
After revie wing the infor mation you provide in response to these com ments and your
amended confidential draft registration state ment or filed registration state ment, we may have
additio nal co mments.
Clinical Results, pages 69 -71
1. We note your revised disclosure reporting datasets and observations from the first
completed cohort of the NEWTON trial and the dataset from patients who received EG -
1962 at HHU Medical Center. In particular, we note your references as to both datasets
regarding “favorable outcomes.” Please clarify your disclosure throughout this section to
quantify your results, explain how you are measuring them, and disclose your criteria for
considering an outcome favorable.
2. We note your response to our prior comme nt 12 and your expanded disclosure on page 70
regarding ITAs. Given that there are no standardized enrollment criteria and there is no
need for regulatory approval prior to conducting the ITAs, please disclose here the extent
to which you may rely on the results of the ITA in future regulatory filings with the FDA.
Brian A. Leuthner
Edge Therapeutics, Inc.
June 6 , 2014
Page 2
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 review 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
correspondence you submit on EDGAR, please properly mark that information in each of your
confidential submissions to us so we do not repeat or refer to that information in our comment
letters to you.
You may contact Christine Torney at (202) 551 -3652 or Mary Mast at (202) 551 -3613 if
you have questions regarding comments on the financial statements and related matters. Please
contact Austin Stephenson at (202) 551 -3192, Dan Greenspan at (202) 551 -3623, or me at (202)
551-3715 with any other questions.
Sincerely,
/s/ Daniel Greenspan for
Jeffrey P. R iedler
Assista nt Direct or
cc: Via E-mail
David S. Rosenthal, Esq.
Dechert LLP