Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 153

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 4
Chunk 153
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2) NDA, submitted by another company
for another drug based on the same active moiety, regardless of whether the drug is intended for the same indication as the original innovative
drug or for another indication, where the applicant does not own or have a legal right of reference to all the data required for approval.
However, an application may be submitted after four years if it contains a certification of patent invalidity or non-infringement to one
of the patents listed with the FDA by the innovator NDA holder.

The FDCA alternatively provides three years of
marketing exclusivity for an NDA, or supplement to an existing NDA if new clinical investigations, other than bioavailability studies,
that were conducted or sponsored by the applicant are deemed by the FDA to be essential to the approval of the application, for example
new indications, dosages or strengths of an existing drug. This three-year exclusivity covers only the modification for which the drug
received approval on the basis of the new clinical investigations and does not prohibit the FDA from approving ANDAs or 505(b)(2) NDAs
for drugs containing the active agent for the original indication or condition of use. Five-year and three-year exclusivity will not delay
the submission or approval of a full NDA. However, an applicant submitting a full NDA would be required to conduct or obtain a right of
reference to any preclinical studies and adequate and well-controlled clinical trials necessary to demonstrate safety and effectiveness.

Controlled Substances

MEAI, the active ingredient in our lead product
candidates may potentially be Schedule as a controlled substance. The CSA and its implementing regulations establish a “closed system”
of regulations for controlled substances. The CSA imposes registration, security, recordkeeping and reporting, storage, manufacturing,
distribution, importation and other requirements under the oversight of the U. S. Drug Enforcement Agency, or the DEA. The DEA is the federal
agency responsible for regulating controlled substances, and requires those individuals or entities that manufacture, import, export,
distribute, research, or dispense controlled substances to comply with the regulatory requirements in order to prevent the diversion of
controlled substances to illicit channels of commerce.

The DEA categorizes controlled substances into
one of five schedules - Schedule I, II, III, IV or V - with varying qualifications for listing in each schedule. Schedule I substances
by definition have a high potential for abuse, have no currently accepted medical use in treatment in the United States and lack accepted
safety for use under medical supervision.