Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 149

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 4
Chunk 149
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 the needs of patients with the rare disease or condition.

Expedited Development and Review Programs

The FDA has a number of programs intended to expedite
the development or review of products that meet certain criteria. For example, new drugs are eligible for Fast Track designation if they
are intended to treat a serious or life-threatening disease or condition and demonstrate the potential to address unmet medical needs
for the disease or condition. Fast track designation applies to the combination of the product and the specific indication for which it
is being studied. The sponsor of a Fast Track-designated product has opportunities for more frequent interactions with the review team
during product development, and the FDA may consider for review sections of the NDA on a rolling basis before the complete application
is submitted, if the sponsor provides a schedule for the submission of the sections of the NDA, the FDA agrees to accept sections of the
NDA and determines that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of
the NDA.

Any product submitted to the FDA for approval,
including a product with a Fast Track designation, may also be eligible for other types of FDA programs intended to expedite development
and review, such as priority review and accelerated approval. A product is eligible for priority review if it has the potential to provide
safe and effective therapy where no satisfactory alternative therapy exists or a significant improvement in the treatment, diagnosis or
prevention of a disease compared to marketed products. The FDA will attempt to direct additional resources to the evaluation of an application
for a new drug designated for priority review in an effort to facilitate the review. The FDA endeavors to review applications with priority
review designations within six months of the filing date as compared to ten months for review of new molecular entity NDAs under its current
PDUFA review goals.

In addition, a product may be eligible for accelerated
approval. Drug products intended to treat serious or life-threatening diseases or conditions may be eligible for accelerated approval
upon a determination that the product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or
on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an
effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the
condition and the availability or lack of alternative treatments. As a condition of approval, the FDA may require that a sponsor of a
drug receiving accelerated approval perform adequate