Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 44

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 3
Chunk 44
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 be able to successfully commercialize our products or product candidates. Even if coverage is provided, the
approved reimbursement amount may not be high enough to allow us to establish or maintain pricing sufficient to realize a sufficient return
on our investment. For products administered under the supervision of a physician, obtaining coverage and adequate reimbursement may be
particularly difficult because of the higher prices often associated with such drugs.

A primary trend in the U. S. healthcare industry
and elsewhere is cost containment. Government authorities and third-party payors have attempted to control costs by limiting coverage
and the amount of reimbursement for particular medications. In many countries, the prices of medical products are subject to varying price
control mechanisms as part of national health systems. In general, the prices of medicines under such systems are substantially lower
than in the United States. Other countries allow companies to fix their own prices for medicines but monitor and control company profits.
Additional foreign price controls or other changes in pricing regulation could restrict the amount that we are able to charge for our
product candidates. Accordingly, in markets outside the United States, the reimbursement for products may be reduced compared with the
United States and may be insufficient to generate commercially reasonable revenues and profits.

There is also significant uncertainty related to
the insurance coverage and reimbursement of newly approved products, and coverage may be more limited than the purposes for which the
medicine is approved by the FDA or comparable foreign regulatory authorities. In the United States, no uniform policy of coverage and
reimbursement for products exists among third-party payors and coverage and reimbursement levels for products can differ significantly
from payor to payor. Commercial payors often rely upon Medicare coverage policy and payment limitations in setting their own policies,
but also have their own methods and approval process apart from Medicare determinations. As a result, the coverage determination process
is often a time consuming and costly process that may require us to provide scientific and clinical support for the use of our products
to each payor separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first
instance. It is difficult to predict what the Centers for Medicare & Medicaid Services, or CMS, the federal agency responsible for
administering the Medicare program, will decide with respect to reimbursement for fundamentally novel products such as ours, as there
is no body of established practices and precedents for these new products. Reimbursement agencies in Europe may be more conservative than
CMS. For example, a number of cancer drugs have been approved for reimbursement in the United States