United States securities and exchange commission logo
May 31, 2020
Mark Godsy
Chief Executive Officer
Shackelford Pharma Inc.
1177 West Hastings St. Suite 2300
Vancouver, BC V6E 2K3
Re: Shackelford Pharma
Inc.
Offering Statement
on Form 1-A
Filed May 4, 2020
File No. 024-11206
Dear Mr. Godsy:
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 filed May 4, 2020
Summary, page 6
1. We note your disclosure
that the Company was created to translate the clinical knowledge
and insights of Dr.
Shackelford, gained through his treatment of more than 25,000 patients
using medical cannabis.
Please place your disclosure in appropriate context by disclosing
that the U.S. Food and
Drug Administration (FDA) has, to date, not approved any
marketing application
for cannabis for the treatment of any disease or condition and has
approved only one
cannabis-derived and three cannabis-related drug products.
Conflicts of Interest, page 31
2. We note the disclosure
on page 53 that Dr. Shannon has served as senior medical advisor
for several Canadian
cannabis LPs. Please expand this risk factor, if applicable, to discuss
any other material
risks related to his "parallel track" within the cannabis business.
Mark Godsy
Shackelford Pharma Inc.
May 31, 2020
Page 2
Description of Business, page 37
3. Please revise to include the information required by Item 8 of Part II
to Form 1- A
CBD & Wellness Products, page 38
4. You appear to describe your CBD & Wellness Products as products that
provide certain
therapeutic benefits, stating, for example, that they "provide
wellness solutions" and that
you are currently targeting "acute pain management." Products that are
intended for use
in the diagnosis, cure, mitigation, treatment, or prevention of
disease and/or intended to
affect the structure or any function of the body are considered drugs
under the Federal
Food, Drug and Cosmetic Act and subject to FDA approval. Please revise
this section to
describe the regulatory status of these products, or revise to avoid
unsubstantiated
therapeutic claims.
Our Products and Services, page 38
5. Please revise this section to disclose in greater detail the current
stage of your business.
Your disclosure should clearly state the current status of
development, the steps you have
taken toward your planned operations, your intended customers and
market(s) in which
you plan to distribute your products, your anticipated timeline, and
the steps remain.
Please provide such disclosure with respect to each of the "channels
of interest" you
intend to pursue. Also, in this regard, we note your statement that
"[m]anagement is
concurrently working towards creating products based upon proprietary
clinical
development plans focused on addressing significant medical
challenges." Please revise to
clarify whether you have started pre-clinical development
6. We note your disclosure that "patent protection is viewed as
essential" for certain of your
products. Additionally, we note the risk factor on page 26 which
states that you are
developing intellectual property and possess trade secrets associated
with your business.
Please provide the material terms and expiration of intellectual
property currently owned
by the company. Refer to Item 7(a)(2) of Form 1-A.
Proprietary Cannabis-based Formulations, page 39
7. Please revise to describe the regulatory process, including all the
processes you must
complete before any of your products will be considered for FDA
approval. For example,
describe the various phases of clinical trials. Please also discuss the
regulatory processes
in Israel and Canada.
FirstName LastNameMark Godsy
8. We note that your proprietary cannabis-based formulations are designed
to address
Comapany NameShackelford Pharma Inc. will initially target the dispensary
channel. Please
"significant medical challenges" and
May 31, 2020this section to clearly disclose the legality of your plans under
U.S. federal law.
revise Page 2
FirstName LastName
Mark Godsy
FirstName LastNameMark Godsy
Shackelford Pharma Inc.
Comapany NameShackelford Pharma Inc.
May 31, 2020
May 31, 2020 Page 3
Page 3
FirstName LastName
Transactions with Related Persons, page 58
9. Please expand to provide all of the information required by Item 13
and the instructions to
Item 13 of Form 1-A, such as the name of each person whose interest in
any transaction is
described. As one example, please expand to describe the transactions
that make up the
balance of the accounts payable to related parties of $119,094 as of
December 31, 2019.
Signatures, page 70
10. Please have your principal accounting officer sign the offering
statement. See Instruction
1 to Signatures of Form 1-A.
Exhibits
11. Please have counsel revise the opinion filed as Exhibit 12.1 to remove
the statement that
with respect to the opinion that the shares will be fully paid and
non-assessable, "[n]o
opinion is expressed as to the adequacy of any consideration
received," or provide an
analysis as to why this statement is necessary and appropriate.
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 David Burton at 202-551-3626 or Kevin Vaughn at
202-551-3494 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Jeffrey Gabor at 202-551-2544 or Mary Beth Breslin at 202-551-3625 with
any other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Daniel D. Nauth, Esq.