Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 142

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 4
Chunk 142
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, but country-specific regulation remains essential in many respects.

U. S. Drug Development Process

In the United States, the FDA regulates drugs under
FDCA and its implementing regulations. The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal,
state, local and foreign statutes and regulations require the expenditure of substantial time and financial resources. Failure to comply
with the applicable U. S. requirements at any time during the product development process, approval process or after approval may subject
an applicant to administrative or judicial sanctions. These sanctions could include the FDA’s refusal to approve pending applications,
withdrawal of an approval, a clinical hold, warning letters, product recalls, product seizures, total or partial suspension of production
or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties.

The process required by the FDA before a drug may
be marketed in the United States generally involves the following:

  completion of preclinical laboratory tests, animal studies and formulation studies in accordance with FDA’s good laboratory practice requirements and other applicable regulations;  

  submission to the FDA of an IND protocol which must become effective before human clinical trials may begin;  
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  approval by an IRB or ethics committee at each clinical site before each trial may be initiated;  
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  performance of adequate and well-controlled human clinical trials in accordance with GCP requirements to establish the safety and efficacy of the proposed drug for its intended use;  
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  submission to the FDA of an NDA after completion of all pivotal trials;  

  payment of user fees for the FDA review of the NDA;  

  a determination by the FDA within 60 days of its receipt of an NDA to file the NDA for review;  

  satisfactory completion of an FDA advisory committee review, if applicable;  

  satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the drug is produced to assess compliance with cGMP requirements to assure that the facilities,...  

  potential FDA audit of the preclinical and/or clinical trial sites that generated the data in support of the NDA, and  

  FDA review and approval of the NDA to permit commercial marketing of the product for particular indications for use in the