Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 16

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 3
Chunk 16
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 relevant biomarkers (with respect to certain of our clinical trials) to be utilized in preclinical and clinical product candid...  

  delays in reaching a consensus with regulatory agencies as to the design or implementation of our clinical studies;  

  delays in reaching agreement on acceptable terms with prospective contract research organizations, or CROs, and clinical trial sites, the terms of which can be subject to extensive negotiation ...  
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  delays in identifying, recruiting and training suitable clinical investigators;  

  delays in obtaining required IRB approval at each clinical trial site;  

  imposition of a temporary or permanent clinical hold by regulatory agencies for a number of reasons, including after review of an IND or amendment, clinical trial application, or CTA, or amendm...  

  developments in trials for other product candidates with the same targets or related modalities as our product candidates conducted by competitors that raise regulatory or safety concerns about...  

  difficulties in securing access to materials for the comparator arm of certain of our clinical trials;  

  delays in identifying, recruiting and enrolling suitable patients to participate in clinical trials, and delays caused by patients withdrawing from clinical trials or failing to return for post...  

  difficulties in finding a sufficient number of trial sites, or trial sites deviating from trial protocol or dropping out of a trial;  

  difficulty collaborating with patient groups and investigators;  

  failure by CROs, other third parties, or us to adhere to clinical trial requirements;  

  failure to perform in accordance with the FDA’s or any other regulatory authority’s current good clinical practices requirements, or GCPs, or regulatory guidelines in other countries, including...  

  the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from nonclinical studies or clinical trials;  
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  occurrence of adverse events, or AEs, undesirable side effects or other unexpected characteristics associated with the product candidate that are viewed to outweigh its potential benefits;  

  changes in regulatory requirements and guidance that require amending or submitting new clinical protocols;  
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  changes in the standard of care on which a clinical development plan was based, which may require new or additional trials;  
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