Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 151

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 4
Chunk 151
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, depending on the significance
of the change, may require prior FDA approval before being implemented. FDA regulations also require investigation and correction of any
deviations from cGMP and impose reporting requirements upon us and any third-party manufacturers that we may decide to use. Accordingly,
manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain compliance with
cGMP and other aspects of regulatory compliance.

The FDA may withdraw approval if compliance with
regulatory requirements and standards is not maintained or if problems occur after the product reaches the market. Later discovery of
previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing processes,
or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information; imposition
of post-market studies or clinical studies to assess new safety risks; or imposition of distribution restrictions or other restrictions
under a REMS program. Other potential consequences include, among other things:

  restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls;  

  fines, warning letters, or untitled letters;  

  clinical holds on clinical studies;  

  refusal of the FDA to approve pending applications or supplements to approved applications, or suspension or revocation of product license approvals;  

  product seizure or detention, or refusal to permit the import or export of products;  

  consent decrees, corporate integrity agreements, debarment or exclusion from federal healthcare programs;  

  mandated modification of promotional materials and labeling and the issuance of corrective information;  

  the issuance of safety alerts, Dear Healthcare Provider letters, press releases and other communications containing warnings or other safety information about the product; or  

  injunctions or the imposition of civil or criminal penalties.  

The FDA also may require post-marketing testing,
known as Phase 4 testing, and surveillance to monitor the effects of an approved product. Discovery of previously unknown problems with
a product or the failure to comply with applicable FDA requirements can have negative consequences, including adverse publicity, judicial
or administrative enforcement, warning letters from the FDA, mandated corrective advertising or communications with doctors, and civil
or criminal penalties, among others. Newly discovered or developed safety or effectiveness data may require changes to a product’s
approved labeling, including the addition of new warnings and contraindications, and also may require the implementation of other risk
management measures.

The FDA closely regulates the marketing, labeling,
advertising and