Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 36

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 3
Chunk 36
---
 product and our company in general, and regulatory agencies may request further data from us. In addition, the information
we choose to publicly disclose regarding a particular study or clinical trial is based on what is typically extensive information, and
you or others may not agree with what we determine is the material or otherwise appropriate information to include in our disclosure.
Any information we determine not to disclose may ultimately be deemed significant by you or others with respect to future decisions, conclusions,
views, activities or otherwise regarding a particular product candidate or our business. If the top-line data that we report differ from
actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval
for, and commercialize any future product candidate, our business, prospects, financial condition and results of operations may be harmed.

Certain of the product candidates we are developing are complex
and difficult to manufacture. We could experience manufacturing problems that result in delays in our development or commercialization
programs or otherwise harm our business.

The manufacturing processes our CMOs use to produce
our product candidates are complex, and materials are challenging to source. Several factors could cause production interruptions, including
inability to develop efficient manufacturing processes, equipment malfunctions, facility contamination, raw material shortages or contamination,
natural disasters, disruption in utility services, human error or disruptions in the operations of our suppliers, including acquisition
of the supplier by a third party or declaration of bankruptcy.

Our CMOs must employ multiple steps to control
the manufacturing process to assure that the process is reproducible and the product candidate is made strictly and consistently in compliance
with the process. Problems with the manufacturing process, even minor deviations from the normal process, could result in product defects
or manufacturing failures that result in lot failures, product recalls, product liability claims or insufficient inventory to conduct
clinical trials or supply commercial markets. We may encounter problems achieving adequate quantities and quality of clinical-grade materials
that meet the FDA, the EMA or other applicable standards or specifications with consistent and acceptable production yields and costs.

In addition, the FDA, the EMA and other foreign
regulatory authorities may require us to submit samples of any lot of any approved product together with the protocols showing the results
of applicable tests at any time. Under some circumstances, the FDA, the EMA or other foreign regulatory authorities may require that we
do not distribute a lot until the agency authorizes its release. Slight deviations in the manufacturing process, including those affecting
quality attributes and stability, may result