Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 154

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 4
Chunk 154
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 They may be used only in federally approved research programs and may not be marketed or sold
for dispensing to patients in the United States. Pharmaceutical product candidates having a currently accepted medical use that are otherwise
approved for marketing may be listed as Schedule II, III, IV or V substances, with Schedule II substances presenting the highest potential
for abuse and physical or psychological dependence, and Schedule V substances presenting the lowest relative potential for abuse and dependence.
The regulatory requirements are more restrictive for Schedule II substances than Schedule III substances. For example, all Schedule II
drug prescriptions must be signed by a physician, physically presented to a pharmacist in most situations and cannot be refilled.

Following NDA approval of a drug containing a Schedule
I controlled substance, that substance must be rescheduled as a Schedule II, III, IV or V substance before it can be marketed. On November
17, 2015, H. R. 639, Improving Regulatory Transparency for New Medical Therapies Act, passed through both houses of Congress. On November
25, 2015 this bill was signed into law. The new law removes uncertainty associated with timing of the DEA rescheduling process after NDA
approval. Specifically, it requires DEA to issue an “interim final rule,” pursuant to which a manufacturer may market its
product candidate within 90 days of FDA approval. The new law also preserves the period of orphan marketing exclusivity for the full seven
years such that this period only begins after DEA scheduling. This contrasts with the previous situation whereby the orphan “clock”
began to tick upon FDA approval, even though the product candidate could not be marketed until DEA scheduling was complete.

Facilities that manufacture, distribute, import
or export any controlled substance must register annually with the DEA. The DEA registration is specific to the particular location, activity(ies)
and controlled substance schedule(s). For example, separate registrations are required for importation and manufacturing activities, and
each registration authorizes which schedules of controlled substances the registrant may handle. However, certain coincident activities
are permitted without obtaining a separate DEA registration, such as distribution of controlled substances by the manufacturer that produces
them.

The DEA inspects all manufacturing facilities to
review security, recordkeeping, reporting and handling prior to issuing a controlled substance registration. The specific security requirements
vary by the type of business activity and the schedule and quantity of controlled substances handled. The most stringent requirements
apply to manufacturers of Schedule I and Schedule II substances. Required security measures commonly include background checks on