Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 19

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 3
Chunk 19
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 of 1970, also known as the Controlled Substances Act, or the CSA. The DEA regulates compounds as
Schedule I, II, III, IV or V substances. Schedule I substances by definition have a high potential for abuse, have no currently “accepted
medical use” in the United States, lack accepted safety for use under medical supervision and may not be prescribed, marketed or
sold in the United States. Pharmaceutical products approved for use in the United States may be listed as Schedule II, III, IV or V, with
Schedule II substances considered to present the highest potential for abuse or dependence and Schedule V substances the lowest relative
risk of abuse among such substances. Schedule I and II drugs are subject to the strictest controls under the CSA, including manufacturing
and procurement quotas, security requirements and criteria for importation. In addition, dispensing of Schedule II drugs is further restricted.
Commercial marketing in the United States will also require scheduling-related legislative or administrative action.

Scheduling determinations by the DEA are dependent
on FDA approval of a substance or a specific formulation of a substance. This scheduling determination will be dependent on FDA approval
and the FDA’s recommendation as to the appropriate schedule. During the review process, and prior to approval, the FDA may determine
that it requires additional data, either from non-clinical or clinical studies, including with respect to whether, or to what extent,
the substance has abuse potential. This may introduce a delay into the approval and any potential rescheduling process. That delay would
be dependent on the quantity of additional data required by the FDA. This scheduling determination will require the DEA to conduct notice
and comment rule making, including issuing an interim final rule. Such action will be subject to public comment and requests for hearing,
which could affect the scheduling of these substances. There can be no assurance that the DEA will make a favorable scheduling decision.
Even assuming categorization as a Schedule II or lower controlled substance (i. e., Schedule III, IV or V), at the federal level, such
substances would also require scheduling determinations under state laws and regulations.

If approved by the FDA, and if any of our product
candidates is listed by the DEA as a Schedule II, III, IV or V controlled substance, their manufacture, importation, exportation, domestic
distribution, storage, sale and legitimate use will continue to be subject to a significant degree of regulation by the DEA. In addition,
the scheduling process may take significantly longer than the 90-day deadline set forth in