Company: CMND
Filing Date: 2025-12-05
Form Type: F-1/A
Source: 0001213900-25-118772
Chunk: 165

Company: Clearmind Medicine Inc.
Filing Date: 2025-12-05
Form: F-1/A
Chunk 165
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 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; |

| ● | approval by an IRB or ethics committee at each clinical site before each trial may be initiated; |

| ● | 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; |

| ● | 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, methods and controls are adequate to preserve the drug’s identity, strength, quality and purity, and of selected clinical investigation sites to assess compliance with GCPs; |

| ● | 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 United States. |

Prior to beginning the first clinical trial with a product candidate in the United States, we must submit an IND to the FDA. An IND is a request for authorization from the FDA to administer an investigational new drug product to humans. The central focus of an IND submission is on the general investigational plan and the protocol(s) for clinical studies. Some preclinical testing may continue even after the IND is submitted. The IND also includes results of animal and in vitrostudies assessing the toxicology, pharmacokinetics, pharmacology, and pharmacodynamic characteristics of the product; chemistry, manufacturing, and controls information; and any available human data or literature to support the use of the investigational product. An IND must become effective before human clinical trials may begin. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, raises