SEC Company Response from Processa Pharmaceuticals, Inc. (PCSA) (CIK 0001533743) (PCSA) — Oct 30, 2018
Processa Pharmaceuticals, Inc. (PCSA) (CIK 0001533743)
Date: Oct. 30, 2018 · CIK: 0001533743 · Accession: 0001493152-18-014992
AI Filing Summary & Sentiment
Reasoning
File numbers found in text: 333-226428
Letter
Via EDGAR United States Securities and Exchange Commission Division of Corporation Finance Office of Healthcare & Insurance Re: Processa Pharmaceuticals, Inc. Amendment No. 2 to Registration Statement on Form S-1 Filed October 9, 2018 File No. 333-226428
Dear Sir or Madaam,
On behalf of Processa Pharmaceuticals, Inc. (“the Company” or “Processa”), we are responding to the comments of the staff of the Division of Corporate Finance of the United States Securities and Exchange Commission set forth in your letter to Dr. David Young, Processa’s Chief Executive Officer, dated October 24, 2018. Your comments are reproduced below in bold, followed in each case by our response on behalf of the Company.
Amendment No. 2 to Form S-1
Description of Business, page 37
1. We note your revised disclosures in response to prior comment 3. However, please further clarify your disclosure to explain how you identified RIF in head and neck cancer patients as an indication to treat with PCS-499 by expanding the ninth paragraph on page 37.
Response
The Company has expanded Description of Business to further clarify how the Company identified RIF in head and neck cancer patients as an indication to treat with PCS-499.
AUSTIN
Boston
CHICAGO
dallas
DENVER
DETROIT
houston
JACKSONVILLE
LOS ANGELES
MADISON
MEXICO CITY
MIAMI
MILWAUKEE
NEW YORK
ORLANDO
SACRAMENTO
SAN DIEGO
SAN FRANCISCO
SILICON VALLEY
TALLAHASSEE
TAMPA
WASHINGTON, D.C.
BRUSSELS
TOKYO
October 30, 2018
Page
2. We note your revised disclosure in response to prior comment 4 regarding the prior trials. Your revised disclosure describes five prior trials, but you state in the ninth paragraph on page 37 that there were six clinical trials, including two studies in patients with chronic kidney disease. Please reconcile your disclosures or revise to add similar disclosure regarding this prior trial. Additionally, we refer to your statement regarding the most common adverse events associated with PCS-499 in the 11th paragraph on page 37. Please revise to disclose all serious adverse events, even if they were later determined not to be related to PCS-499.
Response
The Company has revised Description of Business to discuss clearly all prior trials and their results. Furthermore, the Company has expanded disclosure regarding all serious adverse events which were associated with the Phase 2 studies.
3. Please revise the second sentence in the 11th paragraph on page 37 to clarify the number of patients involved in the Phase 2 trial. Please also describe the primary and secondary endpoints in terms of their objective data points, and whether the endpoints were met.
Response
The Company has revised Description of Business to clarify the number of patients included and has expanded the description of the primary and secondary endpoints in terms of their objective data points and whether the endpoints were met.
If you should have any additional questions, please contact me at (904) 633-8913.
Sincerely,
/s/
Michael B. Kirwan
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CORRESP
1
filename1.htm
ATTORNEYS
AT LAW
One
Independent Drive, Suite 1300
Jacksonville,
FL 32202-5017
904.359.2000
TEL
904.359.8700
FAX
www.foley.com
WRITER’S
DIRECT LINE
904.633.8913
mkirwan@foley.com
EMAIL
CLIENT/MATTER
NUMBER
100830-0118
October
30, 2018
Via
EDGAR
United
States Securities and Exchange Commission
Division
of Corporation Finance
Office
of Healthcare & Insurance
Washington,
D.C. 20549
Re: Processa
Pharmaceuticals, Inc.
Amendment No. 2 to Registration Statement on Form S-1
Filed October 9, 2018
File No. 333-226428
Dear
Sir or Madaam,
On
behalf of Processa Pharmaceuticals, Inc. (“the Company” or “Processa”), we are responding to the comments
of the staff of the Division of Corporate Finance of the United States Securities and Exchange Commission set forth in your letter
to Dr. David Young, Processa’s Chief Executive Officer, dated October 24, 2018. Your comments are reproduced below in bold,
followed in each case by our response on behalf of the Company.
Amendment
No. 2 to Form S-1
Description
of Business, page 37
1. We
note your revised disclosures in response to prior comment 3. However, please further
clarify your disclosure to explain how you identified RIF in head and neck cancer patients
as an indication to treat with PCS-499 by expanding the ninth paragraph on page 37.
Response
The
Company has expanded Description of Business to further clarify how the Company identified RIF in head and neck cancer
patients as an indication to treat with PCS-499.
AUSTIN
Boston
CHICAGO
dallas
DENVER
DETROIT
houston
JACKSONVILLE
LOS
ANGELES
MADISON
MEXICO
CITY
MIAMI
MILWAUKEE
NEW
YORK
ORLANDO
SACRAMENTO
SAN
DIEGO
SAN
FRANCISCO
SILICON
VALLEY
TALLAHASSEE
TAMPA
WASHINGTON,
D.C.
BRUSSELS
TOKYO
October
30, 2018
Page
2
2. We
note your revised disclosure in response to prior comment 4 regarding the prior trials.
Your revised disclosure describes five prior trials, but you state in the ninth paragraph
on page 37 that there were six clinical trials, including two studies in patients with
chronic kidney disease. Please reconcile your disclosures or revise to add similar disclosure
regarding this prior trial. Additionally, we refer to your statement regarding the most
common adverse events associated with PCS-499 in the 11th paragraph on page 37. Please
revise to disclose all serious adverse events, even if they were later determined not
to be related to PCS-499.
Response
The
Company has revised Description of Business to discuss clearly all prior trials and their results. Furthermore, the Company
has expanded disclosure regarding all serious adverse events which were associated with the Phase 2 studies.
3. Please
revise the second sentence in the 11th paragraph on page 37 to clarify the number of
patients involved in the Phase 2 trial. Please also describe the primary and secondary
endpoints in terms of their objective data points, and whether the endpoints were met.
Response
The
Company has revised Description of Business to clarify the number of patients included and has expanded the description
of the primary and secondary endpoints in terms of their objective data points and whether the endpoints were met.
If
you should have any additional questions, please contact me at (904) 633-8913.
Sincerely,
/s/
Michael B. Kirwan
Michael
B. Kirwan
MBK:arm
cc:
Dr. David Young, Chief Executive Officer
John
J. Wolfel, Esq.
Neda A. Sharifi, Ph.D., Esq.