Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 27

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 3
Chunk 27
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 to a greater extent than competing clin...  
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  the size of the study population required for analysis of the trial’s primary endpoints;  

  the severity of the disorder under investigation;  

  the proximity of patients to a trial site;  

  the inclusion and exclusion criteria for the trial in question;  

  the design of the trial protocol;  

  the ability to recruit clinical trial investigators with the appropriate competencies and experience;  

  the approval or concurrent enrollment of clinical trials involving competing product candidates currently under development or competing clinical trials for similar therapies or targeting patie...  

  the availability and efficacy of approved medications or therapies for the disorder or condition under investigation;  

  clinicians’ and patients’ perceptions as to the potential advantages and side effects of the product candidate being studied in relation to other available therapies and product candidates;  

  the ability to obtain and maintain patient consents; and  

  the risk that patients enrolled in clinical trials will not complete such trials, for any reason.  

Additionally, our or our collaborators’ ability
to successfully initiate, enroll and conduct a clinical trial outside the United States is subject to numerous additional risks, including:

  difficulty in establishing or managing relationships with CROs and physicians;  

  differing standards for the conduct of clinical trials;  

  differing standards of care for patients with a particular disorder;  

  an inability to locate qualified local consultants, physicians and partners; and  

  the potential burden of complying with a variety of foreign laws, medical standards and regulatory requirements, including the regulation of pharmaceutical and biotechnology products and treatm...  

Further, successful and timely enrollment in clinical
trials may be adversely affected by global health factors, including, among other things, pandemics such as a resurgence of COVID-19,
such as:

  the diversion of healthcare resources away from the conduct of clinical trial matters to focus on pandemic concerns, including the attention of physicians serving as our clinical trial investig...  

  the limitation of available participants for our trials and a decrease in enrollment of our trials;  
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  the inability of patients, therapists or physicians to come to hospitals and universities to participate in our trials, leading to delays and increased costs;  

  limitations on travel that interrupt key trial activities, such as clinical trial site initiations and monitoring and patient preparation and integration sessions