Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 37

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 3
Chunk 37
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 in unacceptable changes in the product that could result in lot failures or product recalls.
Lot failures or product recalls could cause us to delay product launches or clinical trials, which could be costly to us and otherwise
harm our business, financial condition, results of operations and prospects.

We or our CMOs also may encounter problems hiring
and retaining the experienced scientific, quality assurance, quality-control and manufacturing personnel needed to operate our manufacturing
processes, which could result in delays in production or difficulties in maintaining compliance with applicable regulatory requirements.

Any problems in our or our CMOs’ manufacturing
process or facilities could result in delays in planned clinical trials and increased costs, and could make us a less attractive collaborator
for potential partners, including larger biotechnology companies and academic research institutions, which could limit access to additional
attractive development programs. Problems in our or our CMOs’ manufacturing process could restrict our or their ability to meet
potential future market demand for products.

We may not elect or be able to take advantage of any expedited development
or regulatory review and approval processes available to drug product candidates granted breakthrough therapy or fast track designation
by the FDA.

We intend to evaluate and continue ongoing discussions
with the FDA on regulatory strategies that could enable us to take advantage of expedited development pathways for certain of our product
candidates in the future, although we cannot be certain that our product candidates will qualify for any expedited development pathways
or that regulatory authorities will grant, or allow us to maintain, the relevant qualifying designations. Potential expedited development
pathways that we could pursue include breakthrough therapy and fast track designation.

Breakthrough therapy designation is intended to
expedite the development and review of drug product candidates that are designed to treat serious or life-threatening diseases when preliminary
clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant
endpoints, such as substantial treatment effects observed early in clinical development. The designation of a product candidate as a breakthrough
therapy provides potential benefits that include more frequent meetings with the FDA to discuss the development plan for the product candidate
and ensure collection of appropriate data needed to support approval; more frequent written correspondence from the FDA about such things
as the design of the proposed clinical trials and use of biomarkers; intensive guidance on an efficient drug development program, beginning
as early as Phase 1; organizational commitment involving senior managers; and eligibility for rolling review and priority review.

Fast track designation is designed for drug product
candidates intended for the treatment of