Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 23

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 3
Chunk 23
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 Failure can occur at any time during the clinical development process. Most
product candidates that begin clinical trials are never approved by regulatory authorities for commercialization. We have limited experience
in designing clinical trials and may be unable to design and execute a clinical trial to support marketing approval.

We cannot be certain that our clinical trials will
be successful. Additionally, any safety concerns observed in any one of our clinical trials in our targeted indications could limit the
prospects for regulatory approval of our product candidates in those and other indications, which could have a material adverse effect
on our business, financial condition and results of operations. In addition, even if such clinical trials are successfully completed,
we cannot guarantee that the FDA, the EMA or comparable foreign regulatory authorities will interpret the results as we do, and more trials
could be required before we submit our product candidates for approval. 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.

Additionally, we may utilize an “open-label”
trial design for some of our future clinical trials. An open-label trial is one where both the patient and investigator know whether the
patient is receiving the test article or either an existing approved drug or placebo. Open-label trials are subject to various limitations
that may exaggerate any therapeutic effect as patients in open-label studies are aware that they are receiving treatment. Open-label trials
may be subject to a “patient bias” where patients perceive their symptoms to have improved merely due to their awareness of
receiving an experimental treatment. Patients selected for early clinical studies often include the most severe sufferers, and their symptoms
may have been bound to improve notwithstanding the new treatment. In addition, open-label trials may be subject to an “investigator
bias” where those assessing and reviewing the physiological outcomes of the clinical trials are aware of which patients have received
treatment and may interpret the information of the treated group more favorably given this knowledge. The opportunity for bias in clinical
trials as a result of open-label design may not be adequately handled and may cause any of our trials that utilize such design to fail
or to be considered inadequate and additional trials may be necessary to support future marketing applications. Moreover, results acceptable
to support approval in one jurisdiction may be deemed inadequate by another regulatory authority to support regulatory approval in that
other jurisdiction. To the extent that the results of the trials are not satisfactory to the FDA, the EMA or comparable foreign