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September
14, 2018

Via
EDGAR

United
States Securities and Exchange Commission

Division
of Corporate Finance

Office
of Healthcare and Insurance

Washington,
D.C. 20549

    Re:
    Processa
    Pharmaceuticals, Inc.

    Form
    10-K for the Fiscal Year Ended December 31, 2017

    Filed
    April 16, 2018 (as amended on April 17, 2018)

    Form
    10-Q for the Quarterly Period Ended March 31, 2018 Filed May 21, 2018

    File
    No. 333-184948

Dear
Ladies and Gentlemen,

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, Office of Healthcare and Insurance of the United States Securities and Exchange
Commission set forth in your letter to Dr. David Young, Processa’s Chief Executive Officer, dated August 28, 2018. Your
comments are reproduced below in bold, followed in each case by our response on behalf of the Company.

Annual
Report on Form 10-K/A

Item
1. Business, page 3

    1.
    Please
    expand your disclosure to explain how you identified NL and RIF in head and neck cancer patients as indications for which
    PCS-499 may result in clinical efficacy. Please also explain in terms a lay reader would understand what you mean that your
    product candidate is an “analog of an active metabolite,” and disclose the drug that is already approved, the
    indication for which it was approved, and clarify whether it was approved by the FDA or another regulatory authority.

    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

September
14, 2018

Page
2

 Response

In
future filings, the Company will expand its disclosure to (1) explain, in terms a lay reader would understand, that PCS-499 has
a structure similar to that of an approved drug, but differing from it with respect to a certain functional component of the molecule,
(2) disclose the name and approved indications of the FDA approved analog and (3) explain the process of identification of NL
and RIF in head and neck cancer patients as indications for which PCS-499 may result in clinical efficacy.

    2.
    We
    note your statements that your lead product candidate compound has been shown to be “safe and tolerable,” and
    “with a trend toward efficacy in diabetic nephropathy.” Safety and efficacy determinations are solely within the
    authority of the FDA and comparable regulatory authorities. Please confirm that in future filings, you will revise your disclosures
    to remove all references about your product candidate’s safety and efficacy, including statements regarding preliminary
    indications of efficacy (whether for your planned indication or other indications).

 Response

In
future filings, the Company will revise its disclosure to remove all references to PCS-499 as being effective, including removal
of references to preliminary indications of efficacy. Furthermore, the Company will make similar revisions regarding the safety
of PCS-499.

    3.
    We
    refer to your statement that your business strategy is to identify drugs that can be “quickly” developed within
    “2-4 years.” Please expand your disclosure to discuss the regulatory pathways you intend to pursue for your lead
    and other product candidates and their requirements. If you intend to rely on studies of third parties in seeking approval
    for PCS-499, identify the parties who performed the studies.

Response

In
future filings, the Company will expand the description of its business model to explain the justification for identification
of drugs that can be quickly developed within 2-4 years.

Intellectual
Property, page 4

    4.
    Please
    revise your disclosure to discuss the patents you have licensed relating to your product candidate, including the jurisdiction,
    the type of patent protection (e.g., composition of matter, use, or process), and the patent expiration dates.

September
14, 2018

Page
3

 Response

In
future filings, the Company will expand its intellectual property disclosure to include the quantity, jurisdiction, type and expiration
dates of its licensed patents.

Asset
Acquisitions by Licensing Agreements or Company Acquisitions, page 5

    5.
    Please
    revise this section to discuss the material terms of your CoNCERT agreement and any other material license or collaboration
    agreements you may have at the time, including the nature and scope of the intellectual property transferred, each parties’
    duties and obligations, the term of the agreement, the royalty term, the royalty rates, the termination provisions and any
    potential milestone payments. We also note the discussion on page 68 concerning CoNCERT’s right to have one Board observer
    attend Promet’s Board meetings. If CoNCERT has that right with respect to Processa’s Board meetings, please discuss
    it here.

 Response

In
future filings, the Company will expand its disclosure to include the material terms of the Company’s license agreement
with CoNCERT Pharmaceuticals, Inc. Please note that CoNCERT Pharmaceuticals, Inc. does not have, and never has had, any board
observer rights with the Company as such rights expired upon the assignment of the license agreement from Promet to the Company.
The reference to board observer rights has been removed from the notes to the financial statements.

Item
1A. Risk Factors, page 9

    6.
    Please
    add a risk factor to discuss the material risks associated with the fact that you do not have an audit or compensation committee,
    and that (according to the disclosure in your Registration Statement on Form S-1 filed on July 30, 2018) only one of your
    directors is independent.

 Response

In
future filings, to the extent still applicable, the Company will include a new risk factor to discuss that the Company does not
have an audit committee or compensation committee and that the Company does not have a majority of independent directors.

September
14, 2018

Page
4

We
depend on rights to certain pharmaceutical compounds that are or will be licensed to us. , page 19

    7.
    We
    note your disclosure in this risk factor that your drugs are in-licensed from other biotech or pharmaceutical companies and
    that you do not own the patents that underlie these licenses. Please specify the product candidates that you are referring
    to as well as the patents and the biotech or pharmaceutical companies from whom you have licensed such patents.

 Response

In
future filings, the Company will expand its disclosure to specify the Company’s licensed product candidates as well as the
patents and biotech or pharmaceutical companies from whom the patents have been licensed.

There
may be limitations on the effectiveness of our internal controls, page 26

    8.
    We
    note your disclosure that you experienced a cybersecurity breach that resulted in a fraud loss where the probability of recovery
    of the loss is remote. Please disclose when the breach occurred and quantify the loss in this risk factor.

 Response

In
future filings, the Company will revise its disclosure to include the date and dollar value of the loss suffered by the Company
as a result of the cybersecurity breach.

Item
10. Directors, Executive Officers and Key Employees, page 73

    9.
    Please
    revise your disclosure to explain how Dr. Young helped Questcor transition from being nearly bankrupt to having a valuation
    of over $5 billion in his role as an independent director.

 Response

In
future filings, the Company will revise its disclosure to explain Dr. Young’s role as an independent director and subsequently
as the Chief Scientific Officer of Questcor in transitioning Questcor from nearly a bankrupt company to ultimately the sale of
the company for over $5 billion.

September
14, 2018

Page
5

Form
10-Q for the Quarterly Period Ended March 31, 2018

Notes
to Consolidated Financial Statements

Note
2 - Intangible Asset, page 12

    10.
    You
    disclose that the $11 million intangible asset recorded as of March 31, 2018 includes $3 million of costs capitalized to record
    an offset to a deferred tax liability related to the exercise of your option to acquire an exclusive license from CoNCERT
    related to patent rights and know-how to develop and commercialize compounds and products for CTP-499. You also disclose on
    page 15 that this deferred tax liability was created when CoNCERT sold its license and know-how to you for stock in a transaction
    under Section 351 of the Internal Revenue Code (Section 351 transaction) which treats the acquisition of the license and know-how
    as a tax-free exchange. Please provide us with a detailed analysis explaining how you determined that this transaction met
    the requirements to be considered a tax-free exchange under Section 351. In this regard, it would appear that under Section
    351 an exchange would be considered tax free if (a) the property was exchanged solely for stock of the company and (b) immediately
    after the exchange the transferor controlled the company via 80% or more ownership of voting stock. Based on your beneficial
    ownership table on page 49 of your Form S-1 filed on July 30, 2018, it appears that CoNCERT owns only 5.4% of your outstanding
    shares.

 Response

In
October 2017, Promet Therapeutics LLC., a Delaware limited liability company (“Promet”), and Processa Pharmaceuticals,
Inc., formerly known as Heatwurx Inc. (“Processa”) entered into an Asset Purchase Agreement (the “APA”),
pursuant to which Processa acquired, in an Internal Revenue Code Section 351 tax-free contribution of assets solely for over 80%
of the voting stock of Processa (the “Section 351 Transaction”) by Promet, all of the properties, rights and assets,
including liabilities and commitments, owned by Promet, directly or indirectly, in whole or in part, of every type and description,
real, personal or mixed, tangible and intangible, wherever located and whether or not reflected on the books of Promet (the “Contributed
Assets”, and the transaction as a whole the “Promet/Processa Transaction”).

Included
in the Contributed Assets, Promet also transferred and contributed all, rights, title and interest under a certain option and
license agreement with CoNCERT Pharmaceuticals, Inc. (“CoNCERT”) with respect to certain know-how, patent rights and
compounds developed or obtained by CoNCERT (the “CoNCERT Assets”) for which voting securities of Processa were expressly
contemplated to be issued as part and parcel with, and integrated into, the Section 351 transaction to CoNCERT because all Contributed
Assets including the CoNCERT Assets were contemplated to be integral to each other and were considered to be an integrated undertaking
as the primary target, purpose and reason for the overall transaction itself.

September
14, 2018

Page
6

The
APA was executed pursuant to authority granted by a “Unanimous Written Consent of the Board of Directors of Processa”
dated in September 2017 which demonstrates that both Promet and Processa contemplated and intended that the Asset Purchase and
the CoNCERT Assets were integral to one another and the recipients of equity, being Promet and CoNCERT, in connection therewith
will control the Corporation for purposes of Section 351 and Section 368(c) in that they will own (i) at least 80% of the total
combined voting power of all classes of stock entitled to vote and (ii) at least 80% of the total number of shares of all other
classes of stock of the corporation. The Unanimous Written Consent demonstrates the transfer of all of Promet’s assets,
including but not limited to the transfer of any and all rights relating to the CoNCERT’s Assets to Processa was meant to
be an integrated transaction for tax purposes.

The
Company structured, intended and expressly accepted that the transaction of Promet contributing its and the CoNCERT Assets solely
for stock qualified for Section 351 treatment given that at the conclusion of the events both Promet and CoNCERT controlled more
than 80% of the corporation immediately after the transactions were concluded. The 5.4% of the outstanding shares that were issued
to CoNCERT were part of the overall 90% of the shares (more than the 80% “control” percentage pursuant to Code Section
368(c)) of Processa voting stock acquired as part of an integrated Section 351 Transaction whereby Processa acquired the Contributed
Assets.

September
14, 2018

Page
7

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.