Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 190

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 190
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ivity or listed patents. This six-month exclusivity may
be granted if an NDA sponsor submits pediatric data that fairly respond to a Written Request from the FDA for such data. The data do not
need to show the product to be effective in the pediatric population studied; rather, if the clinical trial is deemed to fairly respond
to the FDA’s request, the additional protection is granted. If reports of requested pediatric studies are submitted to and accepted
by the FDA within the statutory time limits, whatever statutory or regulatory periods of exclusivity or patent protection cover the product
are extended by six months, including orphan drug exclusivity. This is not a patent term extension, but it effectively extends the regulatory
period during which the FDA cannot approve another application. The FDA’s issuance of a Written Request does not require the sponsor
to undertake the described studies.

Orphan Drug Designation and Exclusivity

Under the Orphan Drug Act,
the FDA may designate a drug product as an “orphan drug” if it is intended to treat a rare disease or condition (generally
meaning that it affects fewer than 200,000 individuals in the United States, or more in cases in which there is no reasonable expectation
that the cost of developing and making a drug product available in the United States for treatment of the disease or condition will be
recovered from sales of the product). A company must request orphan product designation before submitting an NDA. If the request is granted,
the FDA will disclose the identity of the therapeutic agent and its potential use. Orphan product designation does not convey any advantage
in or shorten the duration of the regulatory review and approval process.

If a product with orphan designation
subsequently receives the first FDA approval for the disease or condition for which it has such designation or for a select indication
or use within the rare disease or condition for which it was designated, the product generally will receive orphan product exclusivity.
Orphan product exclusivity means that the FDA may not approve any other applications for the same product for the same indication for
seven years, except in certain limited circumstances, such as a showing of clinical superiority to the product with orphan exclusivity
by means of greater effectiveness, greater safety or providing a major contribution to patient care or in instances of drug supply issues.
Competitors, however, may receive approval of either a different product for the same indication for which the orphan product has exclusivity
or for the same product but for a different indication (which could then be used off-label in the orphan indication