Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 152

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 4
Chunk 152
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 promotion of drug products. A company can make only those claims relating to safety and efficacy, purity and potency that
are approved by the FDA and in accordance with the provisions of the approved label. The FDA and other agencies actively enforce the laws
and regulations prohibiting the promotion of off-label uses. Failure to comply with these requirements can result in, among other things,
adverse publicity, warning letters, corrective advertising and potential civil and criminal penalties. Physicians may prescribe, in their
independent professional medical judgment, legally available products for uses that are not described in the product’s labeling
and that differ from those tested by us and approved by the FDA. Physicians may believe that such off-label uses are the best treatment
for many patients in varied circumstances. The FDA does not regulate the behavior of physicians in their choice of treatments. The FDA
does, however, restrict manufacturer’s communications on the subject of off-label use of their products. The federal government
has levied large civil and criminal fines against companies for alleged improper promotion of off-label use and has enjoined companies
from engaging in off-label promotion. The FDA and other regulatory agencies have also required that companies enter into consent decrees
or permanent injunctions under which specified promotional conduct is changed or curtailed. However, companies may share truthful and
not misleading information that is otherwise consistent with a product’s FDA-approved labeling.

In addition, the distribution of prescription pharmaceutical
products is subject to the Prescription Drug Marketing Act, or PDMA, which regulates the distribution of drugs and drug samples at the
federal level and sets minimum standards for the registration and regulation of drug distributors by the states. Both the PDMA and state
laws limit the distribution of prescription pharmaceutical product samples and impose requirements to ensure accountability in distribution.

Marketing Exclusivity

Market exclusivity provisions authorized under
the Food Drug and Cosmetic Act, or FDCA, can delay the submission or the approval of certain marketing applications. The FDCA provides
a five-year period of non-patent marketing exclusivity within the United States to the first applicant to obtain approval of an NDA for
a new chemical entity. A drug is a new chemical entity if the FDA has not previously approved any other new drug containing the same active
moiety, which is the molecule or ion responsible for the action of the drug substance. During the exclusivity period, the FDA may not
approve or even accept for review an ANDA or an NDA submitted under Section 505(b)(2), or 505(b)(