Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 34

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 3
Chunk 34
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 or clinical trials beyond those that we currently anticipate;  
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  the FDA, the EMA or comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials;  
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  the data collected from clinical trials of product candidates that we may identify and pursue may not be sufficient to support the submission of a New Drug Application, or NDA, or other submiss...  
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  we may be unable to demonstrate to the FDA, the EMA or comparable foreign regulatory authorities that a product candidate’s risk-benefit ratio for its proposed indication is acceptable;  
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  the FDA, the EMA or comparable foreign regulatory authorities may identify deficiencies in the manufacturing processes, test procedures and specifications, or facilities of third-party manufact...  
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  the approval policies or regulations of the FDA, the EMA or comparable foreign regulatory authorities may change in a manner that renders the clinical trial design or data insufficient for appr...  
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The lengthy approval process, as well as the unpredictability
of the results of clinical trials and evolving regulatory requirements, may result in our failure to obtain regulatory approval to market
product candidates that we may pursue in the United States or elsewhere, which would significantly harm our business, prospects, financial
condition and results of operations.

Furthermore, approval by the FDA in the United
States, if obtained, does not ensure approval by regulatory authorities in other countries or jurisdictions. In order to market any products
outside of the United States, we must establish and comply with numerous and varying regulatory requirements of other countries regarding
safety and effectiveness. Clinical trials conducted in one country may not be accepted by regulatory authorities in other countries, and
regulatory approval in one country does not mean that regulatory approval will be obtained in