Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 66

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 3
Chunk 66
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, such as an NDA, BLA, PMA or MAA, on a timely basis and must adhere to regulations
enforced by the FDA and other regulatory agencies through their facilities inspection program. Some of our CMOs have never produced a
commercially approved pharmaceutical product and therefore have not obtained the requisite regulatory authority approvals to do so. The
facilities and quality systems of some or all of our third-party contractors must pass a pre-approval inspection for compliance with the
applicable regulations as a condition of regulatory approval of our product candidates or any of our other potential products. In addition,
the regulatory authorities may, at any time, audit or inspect a manufacturing facility involved with the preparation of our product candidates
or our other potential products or the associated quality systems for compliance with the regulations applicable to the activities being
conducted. Although we oversee the CMOs, we cannot control the manufacturing process of, and are completely dependent on, our CMO partners
for compliance with the regulatory requirements. If these facilities do not pass a pre-approval plant inspection, regulatory approval
of the products may not be granted or may be substantially delayed until any violations are corrected to the satisfaction of the regulatory
authority, if ever.

The regulatory authorities also may, at any time
following approval of a product for sale, audit the manufacturing facilities of our third-party contractors. If any such inspection or
audit identifies a failure to comply with applicable regulations or if a violation of product specifications or applicable regulations
occurs independent of such an inspection or audit, we or the relevant regulatory authority may require remedial measures that may be costly
and/or time consuming for us or a third party to implement, and that may include the temporary or permanent suspension of a clinical study
or commercial sales or the temporary or permanent closure of a facility. Any such remedial measures imposed upon us or third parties with
whom we contract could materially harm our business.

Additionally, if supply from one approved manufacturer
is interrupted, an alternative manufacturer would need to be qualified. For drug products, an NDA or MAA variation, or equivalent foreign
regulatory filing is also required, which could result in further delay. Similarly, for a medical device, a new marketing application
or supplement may be required. The regulatory agencies may also require additional studies if a new manufacturer is relied upon for commercial
production. Switching manufacturers may involve substantial costs and is likely to result in a delay in our desired clinical and commercial
timelines.

These factors could cause us