Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 145

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 4
Chunk 145
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’s requirements or if the drug has been associated with unexpected serious harm to patients.

During the development of a new drug, sponsors
are given opportunities to meet with the FDA at certain points. These points may be prior to submission of an IND, at the end of Phase
2, and before an NDA is submitted. Meetings at other times may be requested. These meetings can provide an opportunity for the sponsor
to share information about the data gathered to date, for the FDA to provide advice, and for the sponsor and the FDA to reach agreement
on the next phase of development. Sponsors typically use the meetings at the end of the Phase 2 trial to discuss Phase 2 clinical results
and present plans for the pivotal Phase 3 clinical trials that they believe will support approval of the new drug.

Concurrent with clinical trials, companies usually
complete additional animal studies and must also develop additional information about the chemistry and physical characteristics of the
drug and finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements. The manufacturing
process must be capable of consistently producing quality batches of the product candidate and, among other things, the manufacturer must
develop methods for testing the identity, strength, quality and purity of the final drug. In addition, appropriate packaging must be selected
and tested, and stability studies must be conducted to demonstrate that the product candidate does not undergo unacceptable deterioration
over its shelf life.

While the IND is active and before approval, progress
reports summarizing the results of the clinical trials and nonclinical studies performed since the last progress report must be submitted
at least annually to the FDA, and written IND safety reports must be submitted to the FDA and investigators for serious and unexpected
suspected adverse events, findings from other studies suggesting a significant risk to humans exposed to the same or similar drugs, findings
from animal or in vitrotesting suggesting a significant risk to humans, and any clinically important increased incidence of a
serious suspected adverse reaction compared to that listed in the protocol or investigator brochure.

U. S. Review and Approval Process

Assuming successful completion of all required
testing in accordance with all applicable regulatory requirements, the results of product development, preclinical and other non-clinical
studies and clinical trials, along with descriptions of the manufacturing process, analytical tests conducted on the chemistry of the
drug, proposed labeling and other relevant information are submitted to the FDA as part of an NDA requesting approval to market the product.
Data may come from company-sponsored clinical trials intended to test the