Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 30

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 3
Chunk 30
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ation Guide outlining the risks of the product for distribution to patients and a communication plan to health
care practitioners. Furthermore, if we or others later identify undesirable side effects caused by our product candidates if approved,
several potentially significant negative consequences could result, including:

  regulatory authorities may suspend or withdraw approvals of such product candidate, or seek an injunction against its manufacture or distribution;  
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  regulatory authorities may require additional warnings on the label, including “boxed” warnings, or issue safety alerts, Deal Healthcare Provider letters, press releases or other communications...  
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  we may be required by the FDA to implement a REMS;  
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  we may be required to change the way a product candidate is administered or conduct additional clinical trials;  
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  we may be subject to fines, injunctions or the imposition of civil or criminal penalties;  
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  we could be sued and held liable for harm caused to patients; and  

  our reputation may suffer.  
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Any of these occurrences could prevent us from
achieving or maintaining market acceptance of the particular product candidate, if approved, and may harm our business, financial condition,
results of operations and prospects significantly.

Even if any of our current or future product candidate receives
regulatory approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in
the medical community necessary for commercial success, in which case we may not generate significant revenues or become profitable.

We are a clinical stage company. We have never
commercialized a product, and even if any of our current or future product candidate is approved by the appropriate regulatory authorities
for marketing and sale, it may nonetheless fail to gain sufficient market acceptance by physicians, patients, third-party payors and others
in the medical community. Physicians may be reluctant to take their patients off their current medications and switch their treatment
regimen. Further, patients often acclimate to the treatment regime that they are currently taking and do not want to switch unless their
physicians recommend switching products or they are