Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 143

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 4
Chunk 143
---
 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 safety concerns or questions about the proposed clinical trial. In such
a case, the IND may be placed on clinical hold and the IND sponsor and the FDA must resolve any outstanding concerns or questions before
the clinical trial can begin. Submission of an IND therefore may or may not result in FDA authorization to begin a clinical trial.

Clinical trials involve the administration of the
investigational product to human subjects under the supervision of qualified investigators in accordance with GCPs, which include the
requirement that all research subjects provide their informed consent for their participation in any clinical study. Clinical trials are
conducted under protocols detailing, among other things, the objectives of the study, the parameters to be used in monitoring safety and
the effectiveness criteria to be evaluated. A separate submission to the existing IND must be made for each successive clinical trial
conducted during product development and for any subsequent protocol amendments. Furthermore, an independent IRB for each site proposing
to conduct the clinical trial must review and approve the plan for any clinical trial and its informed consent form before the clinical
trial begins at that site and must monitor the study until completed. An IRB is charged with protecting the welfare and rights of trial
participants and considers such items as whether the risks to individuals participating in the clinical trials are minimized and are reasonable
in relation to anticipated benefits. The IRB also approves the informed consent form that must be provided to each clinical trial subject
or his or her legal representative and must monitor the clinical trial until completed. Regulatory authorities, the IRB or the sponsor
may suspend a clinical trial at any time on various grounds,