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

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 3
Chunk 20
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 the CSA, thereby delaying the launch of our
product candidates in the United States. Furthermore, the FDA, DEA or any foreign regulatory authority could require us to generate more
clinical or other data than we currently anticipate to establish whether or to what extent the substance has an abuse potential, which
could increase the cost and/or delay the launch of our product candidates and any future therapeutic candidates containing controlled
substances. In addition, therapeutic candidates containing controlled substances are subject to DEA regulations relating to manufacturing,
storage, distribution and physician prescription procedures, including:

  DEA registration and inspection of facilities. Facilities conducting research, manufacturing, distributing, importing or exporting, or dispensing controlled substances must be registered (licen...  
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  State-controlled substances laws. Individual U. S. states have also established controlled substance laws and regulations. Though state-controlled substances laws often mirror federal law, beca...  
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  Clinical trials. Research sites must submit a research protocol to the DEA and obtain and maintain a DEA researcher registration that will allow those sites to handle and dispense our product c...  

  Importation. If our product candidates are approved and classified as a Schedule II, III or IV substance, an importer can import them for commercial purposes if it obtains an importer registrat...  
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  Manufacture in the United States. If, because of a Schedule II classification or voluntarily, we were to conduct manufacturing or repackaging/relabeling in the United States, our contract manuf...  
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  Distribution in the United States. If our product candidates are scheduled as Schedule II, III or IV, we would also need to identify wholesale distributors with the appropriate DEA registration...  
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In the event MEAI is evaluated as a controlled
substance and is scheduled under Schedule I of the U. S. Schedules of Controlled Sub