Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 43

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 3
Chunk 43
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successfully, either on our own or in collaboration with third parties, we will not be successful in commercializing our product candidates,
if approved.

The third-party payor coverage and reimbursement status of newly
approved products is uncertain. Our product candidates may become subject to unfavorable pricing regulations or third-party coverage and
reimbursement policies, any of which could harm our business. Failure to obtain or maintain coverage and adequate reimbursement for new
or current products could limit our ability to market those products and decrease our ability to generate revenue.

The regulations that govern marketing approvals,
pricing, coverage and reimbursement for new drugs and other medical products vary widely from country to country. In the United States,
healthcare reform legislation may significantly change the approval requirements in ways that could involve additional costs and cause
delays in obtaining approvals. Some countries require approval of the sale price of a product before it can be marketed. In many countries,
the pricing review period begins after marketing or product licensing approval is granted. In some foreign markets, pricing remains subject
to continuing governmental control even after initial approval is granted. As a result, we might obtain marketing approval for a product
in a particular country but then be subject to price regulations that delay the commercial launch of the product, possibly for lengthy
time periods, and negatively impact the revenue we are able to generate from the sale of the product in that country. Adverse pricing
limitations may hinder our ability to recoup our investment in one or more of our product candidates, even if any of our product candidates
obtain marketing approval.

Our ability to successfully commercialize our product
candidates also will depend in part on the extent to which coverage and adequate reimbursement for these products and related treatments
will be available from government health administration authorities, private health insurers and other organizations. Government authorities
and third-party payors, such as private health insurers and health maintenance organizations, decide which medications they will pay for
and establish reimbursement levels. The availability of coverage and extent of reimbursement by governmental and private payors is essential
for most patients to be able to afford treatments. Sales of these or other product candidates that we may identify will depend substantially,
both domestically and abroad, on the extent to which the costs of our product candidates will be paid by health maintenance, managed care,
pharmacy benefit and similar healthcare management organizations, or reimbursed by government health administration authorities, private
health coverage insurers and other third-party payors. If coverage and adequate reimbursement is not available, or is available only to
limited levels, we may not