Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 148

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 4
Chunk 148
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 addition, new government requirements, including
those resulting from new legislation, may be established, or the FDA’s policies may change, which could impact the timeline for
regulatory approval or otherwise impact ongoing development programs.

Orphan Drug Designation

Under the Orphan Drug Act, the FDA may grant orphan
designation to a drug intended to treat a rare disease or condition, which is a disease or condition that affects fewer than 200,000 individuals
in the United States or, if it affects more than 200,000 individuals in the United States, there is no reasonable expectation that the
cost of developing and making a drug product available in the United States for this type of disease or condition will be recovered from
sales of the product. Orphan designation must be requested before submitting an NDA. After the FDA grants orphan designation, the identity
of the therapeutic agent and its potential orphan use are disclosed publicly by the FDA. Orphan designation does not convey any advantage
in or shorten the duration of the regulatory review and approval process.

If a product that has orphan designation subsequently
receives the first FDA approval for the disease or condition for which it has such designation, the product is entitled to orphan product
exclusivity, which means that the FDA may not approve any other applications to market the same drug or biological product for the same
indication for seven years, except in limited circumstances, such as a showing of clinical superiority to the product with orphan exclusivity
or inability to manufacture the product in sufficient quantities. The designation of such drug also entitles a party to financial incentives
such as opportunities for grant funding towards clinical trial costs, tax advantages and user-fee waivers. Competitors, however, may receive
approval of different products for the indication for which the orphan product has exclusivity or obtain approval for the same product
but for a different indication for which the orphan product has exclusivity. Orphan exclusivity also could block the approval of one of
our products for seven years if a competitor obtains approval of the same drug as defined by the FDA or if our product candidate is determined
to be contained within the competitor’s product for the same indication or disease. If an orphan designated product receives marketing
approval for an indication broader than what is designated, it may not be entitled to orphan exclusivity. In addition, exclusive marketing
rights in the United States may be lost if the FDA later determines that the request for designation was materially defective or if the
manufacturer is unable to assure sufficient quantities of the product to meet