Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 40

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 3
Chunk 40
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 organization designated by a competent authority of an EEA country to conduct conformity assessments.
The Notified Body issues a CE Certificate of Conformity following successful completion of a conformity assessment procedure and quality
management system audit conducted in relation to the medical device and its manufacturer and their conformity with the Essential Requirements.
This Certificate entitles the manufacturer to affix the CE mark to its medical products after having prepared and signed a related EC
Declaration of Conformity.

We could also be required to conduct post-marketing
clinical trials to verify the safety and efficacy of our products in general or in specific patient subsets. If original marketing approval
of a drug was obtained via an accelerated approval pathway, we could be required to conduct a successful post-marketing clinical trial
to confirm clinical benefit for our products. An unsuccessful post-marketing study or failure to complete such a study could result in
the withdrawal of marketing approval.

If a regulatory agency discovers previously unknown
problems with a product, such as AEs of unanticipated severity or frequency, or problems with the facility where the product is manufactured,
or disagrees with the promotion, marketing or labeling of a product, such regulatory agency may impose restrictions on that product or
us, including requiring withdrawal of the product from the market. If we fail to comply with applicable regulatory requirements, a regulatory
agency or enforcement authority may, among other things:

  issue warning letters or untitled letters;  

  impose civil or criminal penalties;  

  suspend, withdraw or modify regulatory approvals;  

  suspend or modify any of our ongoing clinical trials;  

  refuse to approve pending applications or supplements to approved applications submitted by us;  

  mandate modifications to promotional materials or require us to provide corrective information to healthcare practitioners, or require other restrictions on the labeling or marketing of such pr...  

  impose restrictions on our operations, including closing our programs’ or our or their CMOs’ facilities;  

  seize or detain products, refuse to permit the import or export of products; or  

  require a product recall.  

Any government investigation of alleged violations
of law could require us to expend significant time and resources in response, and could generate negative publicity. Any failure to comply
with ongoing regulatory requirements may significantly and adversely affect our, our ability to commercialize and generate revenue. If
regulatory sanctions are applied or if regulatory approval is withdrawn, the value of our Company and our operating results will be adversely
affected.

The FDA’s and other regulatory authorities’
policies may change and additional government regulations may be enacted