United States securities and exchange commission logo
April 16, 2021
Michael Mulholland
Chief Financial Officer
CytoDyn Inc.
1111 Main Street, Suite 660
Vancouver, Washington 98660
Re: CytoDyn Inc.
Form 10-K for the
Fiscal Year ended May 31, 2020
File No. 000-49908
Dear Mr. Mulholland:
We have reviewed your March 23, 2021 response to our comment
letter and have the
following comment. In our comment, we may ask you to provide us with
information so we may
better understand your disclosure.
Please respond to this comment within ten business days by
providing the requested
information or advise us as soon as possible when you will respond. If
you do not believe our
comment applies to your facts and circumstances, please tell us why in
your response.
After reviewing your response to this comment, we may have
additional
comments. Unless we note otherwise, our references to prior comments are
to comments in our
February 18, 2021 letter.
Form 10-K for the Fiscal Year ended May 31, 2020
Financial Statements
Note 2 -- Summary of Significant Accounting Policies
Inventories Procured or Produced in Preparation for Product Launches,
page 84
1. We do not believe your
response to prior comment 2 from our letter dated February 18,
2021, provides a
sufficient basis to support management s assertion that prelaunch
inventory represented
an asset at each date it was capitalized. For example:
You assert that
your meetings with the FDA addressed safety and efficacy of the
drug. However, the
FDA s July 2020 Refusal to File letter states that your Biologics
License Application
omitted information necessary for the FDA to perform a
substantive review
of the product s safety and effectiveness.
You indicate that
current scientific work being performed by the Company to
complete a
successful resubmission of the Company s BLA is ongoing and that you
Michael Mulholland
CytoDyn Inc.
April 16, 2021
Page 2
do not expect to resubmit your BLA until mid-calendar year 2021
or shortly
thereafter.
You assert that you manufactured leronlimab consistent with cGMP
standards.
However, we note that the FDA s September 20, 2020, response to
your list of
questions related to the Refusal to File letter continued to
reference issues with your
clinical and statistical data, device related issues, and
chemical manufacturing and
control related issues.
We request that management reconsider the appropriateness of its
capitalization
conclusion in light of the examples above and tell us whether
management believes there
is any additional information bearing on these examples to support its
capitalization
conclusion. Please also propose revised disclosure that more fully
conveys the points in
the examples above.
You may contact Jeanne Baker at 202-551-3691 or Terence O'Brien at
202-551-3355 if
you have questions regarding the comment.
FirstName LastNameMichael Mulholland Sincerely,
Comapany NameCytoDyn Inc.
Division of
Corporation Finance
April 16, 2021 Page 2 Office of Life
Sciences
FirstName LastName