Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 24

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 3
Chunk 24
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 regulatory
authorities for support of a marketing application, we may be required to expend significant resources, which may not be available to
us, to conduct additional trials in support of potential approval of our product candidates. Even if regulatory approval is secured for
a product candidate, the terms of such approval may limit the scope and use of the specific product candidate, which may also limit its
commercial potential.

Even if we complete the necessary preclinical studies and clinical
trials, the marketing approval process is expensive, time consuming and uncertain and may prevent us from obtaining approvals for the
potential commercialization of our product candidates.

Any product we may develop and the activities associated
with their development and potential commercialization, including their design, testing, manufacture, safety, efficacy, recordkeeping,
labeling, storage, approval, advertising, promotion, sale and distribution, are subject to comprehensive regulation by the FDA, the EMA
and other comparable foreign regulatory authorities. Failure to obtain marketing authorization for a product candidate will prevent us
from commercializing the product candidate in a given jurisdiction.

We expect to rely on assistance from third-party
CROs or regulatory consultants to assist us in filing and supporting the applications necessary to gain marketing authorizations. Securing
regulatory approval requires the submission of extensive preclinical and clinical data and supporting information to the various regulatory
authorities for each therapeutic indication to establish the product candidate’s safety, purity, efficacy and potency. Securing
regulatory approval also requires the submission of information about the product manufacturing process to, and inspection of manufacturing
facilities by, the relevant regulatory authority. Any product candidates we develop may not be effective, may be only moderately effective,
or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude our obtaining marketing
approval or prevent or limit commercial use, if approved.

The process of obtaining marketing authorizations,
both in the United States and abroad, is expensive, may take many years if additional clinical trials are required, if approval is obtained
at all, and can vary substantially based upon a variety of factors, including the type, complexity and novelty of the product candidates
involved.

Changes in marketing authorization policies during
the development period, changes in or the enactment of additional statutes or regulations, or changes in regulatory review for each submitted
product application, may cause delays in the approval or rejection of an application. The FDA and comparable authorities in other countries
have substantial discretion in the approval process and may refuse to accept any application or may