Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 200

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 200
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, the proposed orphan drug will be of significant benefit to patients.

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Orphan drug designation is
not a marketing authorization. It is a designation that provides a number of benefits, including fee reductions, regulatory assistance,
and the possibility to apply for a centralized European Union marketing authorization, as well as ten years of market exclusivity following
a marketing authorization. During this market exclusivity period, neither the EMA, the European Commission nor the member states can accept
an application or grant a marketing authorization for a similar medicinal product. A “similar medicinal product” is defined
as a medicinal product containing a similar active substance or substances as those contained in an authorized orphan medicinal product
and that is intended for the same therapeutic indication. The market exclusivity period for the authorized therapeutic indication may
be reduced to six years if, at the end of the fifth year, it is established that the orphan designation criteria are no longer met, including
where it is shown that the product is sufficiently profitable not to justify maintenance of market exclusivity. In addition, a competing
similar medicinal product may in limited circumstances be authorized prior to the expiration of the market exclusivity period, including
if it is shown to be safer, more effective or otherwise clinically superior to the already approved orphan drug. Furthermore, a product
can lose orphan designation, and the related benefits, prior to us obtaining a marketing authorization if it is demonstrated that the
orphan designation criteria are no longer met.

General Data Protection Regulation

As further discussed in “Risk
Factors” under the heading “We may incur substantial costs in our efforts to comply with evolving global data protection laws and regulations, and any failure or perceived failure by us to comply with such laws and regulations may harm our business and operations,”
the collection, use, disclosure, transfer, or other processing of personal data regarding individuals in the European Union and United
Kingdom, including personal health data, is subject to the GDPR and UK GDPR, respectively, which are wide-ranging in scope and impose
numerous requirements on companies that process personal data, impose strict rules on the transfer of personal data to countries outside
the European Union and United Kingdom, respectively, and permits data protection authorities to impose large penalties for violations.
Compliance with the GDPR and UK GDPR is a rigorous and time-intensive process that may increase the cost of doing business or require
companies to change their business practices to ensure full compliance.

Pricing Decisions for Approved Products

In the European Union, pricing
and reimbursement schemes vary widely from country