Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 62

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 3
Chunk 62
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 one with us for any future product candidate.

Management of our relationships with collaborators
will require:

  significant time and effort from our management team;                                                                                                     
  coordination of our marketing and research and development programs with the marketing and research and development priorities of our collaborators; and  
  effective allocation of our resources to multiple projects.                                                                                               

We rely on third parties to assist in conducting our clinical trials
and some aspects of our research and preclinical testing, and those third parties may not perform satisfactorily, including failing to
meet deadlines for the completion of such trials, research, or testing.

We currently rely and expect to continue to rely
on third parties, such as CROs, clinical data management organizations, medical institutions and clinical investigators, to conduct some
aspects of research and preclinical testing and clinical trials. Any of these third parties may terminate their engagements with us or
be unable to fulfill their contractual obligations. If any of our relationships with these third parties terminate, we may not be able
to enter into arrangements with alternative third parties on commercially reasonable terms, or at all. If we need to enter into alternative
arrangements, it could delay product development activities.

Further, although our reliance on these third parties
for clinical development activities limits our control over these activities, we remain responsible for ensuring that each trial is conducted
in accordance with the applicable protocol, legal and regulatory requirements and scientific standards. For example, notwithstanding the
obligations of a CRO for a trial of one of our product candidates, we remain responsible for ensuring that each clinical trial is conducted
in accordance with the general investigational plan and protocols for the trial. Moreover, the FDA requires compliance with requirements,
commonly referred to as GCPs for conducting, recording and reporting the results of clinical trials to assure that data and reported results
are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected. The FDA enforces these
GCPs through periodic inspections of trial sponsors, principal investigators, clinical trial sites and IRBs. If we or our third-party
contractors fail to comply with applicable GCPs, the clinical data generated in their clinical trials may be deemed unreliable, and the
FDA may require additional clinical trials before approving our product candidates, which would delay the regulatory approval process.
We cannot be certain that, upon inspection, the FDA will determine that any of our clinical trials comply with GCPs. We are also required
to register certain clinical trials and post the results of