Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 150

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 4
Chunk 150
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 and well-controlled post-marketing clinical trials. In addition, the FDA currently
requires pre-approval of promotional materials as a condition for accelerated approval, which could adversely impact the timing of the
commercial launch of the product.

In addition, the Food and Drug Administration Safety
and Innovation Act established a category of drugs referred to as “breakthrough therapies” that may be eligible to receive
breakthrough therapy designation. A sponsor may seek FDA designation of a product candidate as a “breakthrough therapy” if
the product is intended, alone or in combination with one or more other products, to treat a serious or life-threatening disease or condition
and preliminary clinical evidence indicates that the product may demonstrate substantial improvement over existing therapies on one or
more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. The designation includes
all of the Fast Track program features, as well as more intensive FDA interaction and guidance. The breakthrough therapy designation is
a distinct status from both accelerated approval and priority review, which can also be granted to the same drug if relevant criteria
are met. If a product is designated as breakthrough therapy, the FDA will work to expedite the development and review of such drug.

Fast Track designation, breakthrough therapy designation,
priority review, and accelerated approval do not change the standards for approval, but may expedite the development or approval process.
Even if a product qualifies for one or more of these programs, the FDA may later decide that the product no longer meets the conditions
for qualification or decide that the time period for FDA review or approval will not be shortened. We may explore some of these opportunities
for our product candidates as appropriate.

Post-approval Requirements

Any products manufactured or distributed pursuant
to FDA approvals are subject to pervasive and continuing regulation by the FDA, including, among other things, requirements relating to
record-keeping, reporting of adverse experiences, periodic reporting, product sampling and distribution, and advertising and promotion
of the product. After approval, most changes to the approved product, such as adding new indications or other labeling claims, are subject
to prior FDA review and approval. There also are continuing, annual program fees for any marketed products. Drug manufacturers and their
subcontractors are required to register their establishments with the FDA and certain state agencies and are subject to periodic unannounced
inspections by the FDA and certain state agencies for compliance with cGMP, which impose certain procedural and documentation requirements
upon us and our third-party manufacturers. Changes to the manufacturing process are strictly regulated, and