Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 38

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 3
Chunk 38
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 a serious or life-threatening disease or disorder, where preclinical or clinical data demonstrate
the potential to address an unmet medical need for this disease or disorder. Accordingly, even if we believe a particular product candidate
is eligible for breakthrough therapy or fast track designation, we cannot assure you that the FDA would decide to grant it. Breakthrough
therapy designation and fast track designation do not change the standards for product approval, and there is no assurance that such designation
or eligibility will result in expedited review or approval or that the approved indication will not be narrower than the indication covered
by the breakthrough therapy designation or fast track designation. Thus, even if we receive breakthrough therapy or fast track designation,
we may not experience a faster development process, review or approval compared to conventional FDA procedures. The FDA may withdraw breakthrough
therapy or fast track designation if it believes that the product no longer meets the qualifying criteria. Our business may be harmed
if we are unable to avail ourselves of these or any other expedited development and regulatory pathways.

For any approved product, we will be subject to ongoing regulatory
obligations and continued regulatory review, which may result in significant additional expense, and we may be subject to penalties if
we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates.

If any of our product candidates are approved,
they will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, advertising, promotion, sampling,
record-keeping, conduct of post-marketing studies, and submission of safety, efficacy and other post-market information, including both
federal and state requirements in the United States and requirements of comparable foreign regulatory authorities.

Manufacturers and manufacturers’ facilities
are required to comply with extensive requirements imposed by the FDA, the EMA and other comparable foreign regulatory authorities, including
ensuring that quality control and manufacturing procedures conform to current good manufacturing practices, or cGMP, regulations. As such,
we and our CMOs are subject to continual review and inspections to assess compliance with cGMP and adherence to commitments made in any
NDA or marketing authorization application, or MAA, or equivalent application. We and our CMOs are also subject to requirements pertaining
to the registration of our and their manufacturing facilities and the listing of our product and product candidates with the FDA; continued
complaint, adverse event and malfunction reporting; corrections and removals reporting and labeling and promotional requirements. Accordingly,
we and others with whom we work must continue to expend time, money and effort in