Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 158

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 4
Chunk 158
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 end of the fifth year, it is established that the product no longer meets the criteria for which it
received orphan drug destination, that is the prevalence of the condition has increased above the threshold or it is judged that the product
is sufficiently profitable not to justify maintenance of market exclusivity. Granting of an authorization for another similar orphan medicinal
product where another product has market exclusivity can happen only in selected cases, such as, for example, demonstration of “clinical
superiority” by a similar medicinal product, inability of a manufacturer to supply sufficient quantities of the first product or
where the manufacturer itself gives consent. A company may voluntarily remove a product from the orphan register. Medicinal products or
medicinal product candidates designated as orphan are eligible for incentives made available by the European Union and its Member States
to support research into, development and availability of orphan medicinal products.

Adaptive pathways. The EMA has an adaptive
pathways program which allows for early and progressive patient access to a medicine. The adaptive pathways concept is an approach to
medicines approval that aims to improve patients’ access to medicines in cases of high unmet medical need. To achieve this goal,
several approaches are envisaged: identifying small populations with severe disease where a medicine’s benefit-risk balance could
be favorable; making more use of real-world data where appropriate to support clinical trial data; and involving health technology assessment
bodies early in development to increase the chance that medicines will be recommended for payment and ultimately covered by national healthcare
systems. The adaptive pathways concept applies primarily to treatments in areas of high medical need where it is difficult to collect
data via traditional routes and where large clinical trials would unnecessarily expose patients who are unlikely to benefit from the medicine.
The approach builds on regulatory processes already in place within the existing EU legal framework. These include: scientific advice;
compassionate use; the conditional approval mechanism (for medicines addressing life-threatening conditions); patient registries and other
pharmacovigilance tools that allow collection of real-life data and development of a risk-management plan for each medicine.

The adaptive pathways program does not change the
standards for the evaluation of benefits and risks or the requirement to demonstrate a positive benefit-risk balance to obtain marketing
authorization.

PRIME scheme. In July 2016, the EMA launched
the PRIME scheme. PRIME is a voluntary scheme aimed at enhancing the EMA’s support for the development of medicines that target
unmet medical needs. It is based on increased interaction and