United States securities and exchange commission logo
June 24, 2020
Joshua R. Lamstein
Co-Chairman
Scopus BioPharma Inc.
420 Lexington Avenue, Suite 300
New York, NY 10170
Re: Scopus BioPharma
Inc.
Offering Statement
on Form 1-A
Filed May 29, 2020
File No. 024-11228
Dear Mr. Lamstein:
We have reviewed your offering 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 amending your offering 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 offering statement and
the information you
provide in response to these comments, we may have additional comments.
Offering Statement on Form 1-A
Summary
Proprietary CBD-mediated, Opioid-sparing Anesthetics, page 2
1. We note your disclosure
that Dr. Binshtok has demonstrated in mice that CBD can be
used as an alternative
to capsaicin in combination with chloroprocaine, resulting in
painless selective
long-term pain relief without paralytic, autonomic or neurotoxic side
effects. This statement
implies efficacy, which is a determination solely within the
authority of the FDA or
similar foreign regulators. You may present objective data
resulting from trials
without concluding efficacy. Please revise this statement accordingly.
2. We note your disclosure
that you believe that your proprietary combinations of CBD with
approved anesthetics
may be eligible for the FDA's 505(b)(2) development pathway,
which would
significantly reduce the future time and costs associated with clinical
development, and
similar statements about potential expedited review in the Business
Joshua R. Lamstein
Scopus BioPharma Inc.
June 24, 2020
Page 2
section. Please revise to make it clear here and in the Business section
that there can be
no assurance that you will be able to use the 505(b)(2) regulatory
pathway for your
product candidates or that any of your product candidates will receive
an expedited
review.
MRI-1867, page 4
3. We note your disclosure that NIH researchers demonstrated that MRI-1867
has an
acceptable safety profile. Safety is a determination that is solely
within the authority of the
FDA or similar foreign regulators. You may state that your product
candidates are well
tolerated if true. Please revise this statement accordingly.
We will consider qualifying your offering statement at your request. If
a participant in
your offering is required to clear its compensation arrangements with FINRA,
please have
FINRA advise us that it has no objections to the compensation arrangements
prior to
qualification.
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. We also remind you that, following qualification of your
Form 1-A, Rule 257
of Regulation A requires you to file periodic and current reports, including a
Form 1-K which
will be due within 120 calendar days after the end of the fiscal year covered
by the report.
You may contact Julie Sherman at 202-551-3640 or Brian Cascio at
202-551-3676 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Ada D. Sarmento at 202-551-3798 or Celeste Murphy at 202-551-3257 with
any other
questions.
Sincerely,
FirstName LastNameJoshua R. Lamstein
Division of
Corporation Finance
Comapany NameScopus BioPharma Inc.
Office of Life
Sciences
June 24, 2020 Page 2
cc: Mark J. Wishner, Esq.
FirstName LastName