Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 160

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 4
Chunk 160
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eline for Good Clinical Practice (ICH-GCP E6); and  

  the International Standard Organisation (ISO); ISO 14155-1; ISO 14155-2: Clinical Investigation of Medical Devices for Human Subjects.  

In the event of an inconsistency between the aforesaid
guidelines, the guidelines of the MOH shall prevail. In matters not covered by binding provisions in the guidelines of MOH, the international
guidelines should be followed.

Informed Consent in Human Clinical Trials

Apart from exceptional cases, clinical trial participants
must sign on an “informed consent” form, pre-approved by the applicable Helsinki Committee.

Human Clinical Trials Pre-Conditions

The following conditions must be met prior to the
beginning of any such trial:

  Insurance – the sponsor of the trial must provide appropriate insurance coverage.  

  Free supply of the investigational product to the trial participants shall be guaranteed throughout the duration of the trial. A participant must not pay to participate in the trial.  

  The trial protocol must include provisions for safeguarding participants’ privacy and confidentiality of gathered information.  

Clinical Trial Agreements

Every contractual agreement between a clinical
trial sponsor and a principal investigator conducting a clinical trial requires approval by the Committee for Contracts with Commercial
Companies and by the Director of the medical institution in which the trial is conducted or designee thereof appointed for this purpose,
such as the director of the institutional research fund. Approval by the director of the institution is also required for any contract
between a Sponsor or representative thereof and a Principal Investigator or any other Investigator who is taking part in the clinical
trial.

Controlled Substance Status in the U. S., Canada and
Israel

In the U. S., MEAI has not been officially evaluated
for its status as a controlled substance. It is currently unknown how it will be scheduled by the FDA, and it is not currently found in
Schedule II of the US Schedules of Controlled Substances. However, if the molecule is considered to be similar to amphetamines or other
control substances, then it may fall under this schedule as a stimulant, under which you will find amphetamine or other control substances
listed. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains
any quantity of the following substances having a stimulant effect on the central nervous system are in this schedule: amphetamine, its
salts, optical isomers, and salts of its optical isomers. This molecule also