Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 146

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 4
Chunk 146
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 safety and effectiveness of a use of a product, or from a number
of alternative sources, including studies initiated by investigators. To support marketing approval, the data submitted must be sufficient
in quality and quantity to establish the safety and effectiveness of the investigational drug product to the satisfaction of the FDA.
The submission of an NDA is subject to the payment of substantial user fees; a waiver of such fees may be obtained under certain limited
circumstances. Additionally, no user fees are assessed on NDAs for products designated as orphan drugs, unless the product also includes
a non-orphan indication.

The FDA reviews an NDA to determine, among other
things, whether a product is safe and effective for its intended use and whether its manufacturing is cGMP-compliant to assure and preserve
the product’s identity, strength, quality and purity. Under the Prescription Drug User Fee Act, or PDUFA, guidelines that are currently
in effect, the FDA has a goal of ten months from the date of “filing” of a standard NDA for a new molecular entity to review
and act on the submission. This review typically takes twelve months from the date the NDA is submitted to FDA because the FDA has approximately
two months to make a “filing” decision after it the application is submitted. The FDA conducts a preliminary review of all
NDAs within the first 60 days after submission, before accepting them for filing, to determine whether they are sufficiently complete
to permit substantive review. The FDA may request additional information rather than accept an NDA for filing. In this event, the NDA
must be resubmitted with the additional information. The resubmitted application also is subject to review before the FDA accepts it for
filing.

The FDA may refer an application for a novel drug
to an advisory committee. An advisory committee is a panel of independent experts, including clinicians and other scientific experts,
that reviews, evaluates and provides a recommendation as to whether the application should be approved and under what conditions. The
FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions.

Before approving an NDA, the FDA will typically
inspect the facility or facilities where the product is manufactured. The FDA will not approve an application unless it determines that
the manufacturing processes and facilities are in compliance with cGMP and adequate to assure consistent production of the product within
required specifications. Additionally, before approving an NDA, the FDA will typically inspect one or