Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 147

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 4
Chunk 147
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 more clinical sites to assure compliance
with GCPs. If the FDA determines that the application, manufacturing process or manufacturing facilities are not acceptable, it will outline
the deficiencies in the submission and often will request additional testing or information. Notwithstanding the submission of any requested
additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval.

After the FDA evaluates an NDA, it will issue an
approval letter or a Complete Response Letter. An approval letter authorizes commercial marketing of the drug with prescribing information
for specific indications. A Complete Response Letter indicates that the review cycle of the application is complete, and the application
will not be approved in its present form. A Complete Response Letter usually describes the specific deficiencies in the NDA identified
by the FDA and may require additional clinical data, such as an additional pivotal Phase 3 trial or other significant and time-consuming
requirements related to clinical trials, nonclinical studies or manufacturing. If a Complete Response Letter is issued, the sponsor must
resubmit the NDA, addressing all of the deficiencies identified in the letter, or withdraw the application. Even if such data and information
are submitted, the FDA may decide that the NDA does not satisfy the criteria for approval.

If regulatory approval of a product is granted,
such approval will be granted for particular indications and may contain limitations on the indicated uses for which such product may
be marketed. For example, the FDA may approve the NDA with a Risk Evaluation and Mitigation Strategy, or REMS, to ensure the benefits
of the product outweigh its risks. A REMS is a safety strategy to manage a known or potential serious risk associated with a medicine
and to enable patients to have continued access to such medicines by managing their safe use, and could include medication guides, physician
communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries, and other risk minimization
tools. The FDA also may condition approval on, among other things, changes to proposed labeling or the development of adequate controls
and specifications. Once approved, the FDA may withdraw the product approval if compliance with pre- and post-marketing requirements is
not maintained or if problems occur after the product reaches the marketplace. The FDA may also require one or more Phase 4 post-market
studies and surveillance to further assess and monitor the product’s safety and effectiveness after commercialization and may limit
further marketing of the product based on the results of these post-marketing studies. In