Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 181

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 181
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 a variety of cancers in which the goal of
therapy is generally to improve survival or decrease morbidity and the duration of the typical disease course requires lengthy and sometimes
large clinical trials to demonstrate a clinical or survival benefit.

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The accelerated approval pathway
is usually contingent on a sponsor’s agreement to conduct, in a diligent manner, additional post-approval confirmatory studies to
verify and describe the drug’s clinical benefit. As a result, a drug candidate approved on this basis is subject to rigorous post-marketing
compliance requirements, including the completion of Phase 4 or post-approval clinical trials to confirm the effect on the clinical endpoint.
Failure to conduct required post-approval studies, or confirm a clinical benefit during post-marketing studies, would allow the FDA to
withdraw the drug from the market on an expedited basis. All promotional materials for drug candidates approved under accelerated regulations
are subject to prior review by the FDA. As part of the Consolidated Appropriations Act for 2023, Congress provided FDA additional statutory
authority to mitigate potential risks to patients from continued marketing of ineffective drugs previously granted accelerated approval.
Under the act’s amendments to the FDCA, FDA may require the sponsor of a product granted accelerated approval to have a confirmatory
trial underway prior to approval. The sponsor must also submit progress reports on a confirmatory trial every six months until the trial
is complete, and such reports are published on FDA’s website. The amendments also give FDA the option of using expedited procedures
to withdraw product approval if the sponsor’s confirmatory trial fails to verify the claimed clinical benefits of the product.

The FDA’s Decision on an NDA or BLA

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. The FDA reviews a BLA to determine, among other things
whether the product is safe, pure and potent and the facility in which it is manufactured, processed, packed or held meets standards designed
to assure the product’s continued safety, purity and potency. The approval process is lengthy and often difficult, and the FDA may
refuse to approve an NDA or BLA if the applicable regulatory criteria are not satisfied or may require additional clinical or other data
and information. On the basis of the FDA’s evaluation of the NDA and accompanying information, including the results of the inspection
of