Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 35

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 3
Chunk 35
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 any other country. Approval processes vary
among countries and can involve additional product testing and validation and additional or different administrative review periods from
those in the United States, including additional preclinical studies or clinical trials, as clinical trials conducted in one jurisdiction
may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictions outside the United States, a product candidate
must be approved for reimbursement by insurers before it can be approved for sale in that jurisdiction. In some cases, the price that
we intend to charge for our products is also subject to approval.

Seeking foreign regulatory approval could result
in difficulties and costs for us and require additional preclinical studies or clinical trials which could be costly and time consuming.
Regulatory requirements can vary widely from country to country and could delay or prevent the introduction of our products in those countries.
The foreign regulatory approval process involves all of the risks associated with FDA approval. We do not have any product candidates
approved for sale in international markets. If we fail to comply with regulatory requirements in international markets or to obtain and
maintain required approvals, or if regulatory approvals in international markets are delayed, our target market will be reduced and our
ability to realize the full market potential of our products will be harmed.

Interim, “top-line,” and preliminary data from our clinical
trials that we announce or publish from time to time may change as more patient data become available or as additional analyses are conducted,
and as the data are subject to audit and verification procedures that could result in material changes in the final data.

From time to time, we may publish interim, “top-line,”
or preliminary data from our clinical studies. Interim data from clinical trials are subject to the risk that one or more of the clinical
outcomes may materially change as patient enrollment continues and more patient data become available. Preliminary or “top-line”
data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary
data we previously published. As a result, interim and preliminary data should be viewed with caution until the final data are available.
Material adverse changes between preliminary, “top-line,” or interim data and final data could significantly harm our business
prospects.

Further, others, including regulatory agencies,
may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance
of data differently, which could impact the value of the particular program, the approvability or commercialization of the particular
product candidate or