Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 179

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 179
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 clinical endpoint is a measurement of a therapeutic effect that is considered
reasonably likely to predict the clinical benefit of a drug or biologic, such as an effect on IMM. The FDA has limited experience with
accelerated approvals based on intermediate clinical endpoints, but has indicated that such endpoints generally may support accelerated
approval where the therapeutic effect measured by the endpoint is not itself a clinical benefit and basis for traditional approval, if
there is a basis for concluding that the therapeutic effect is reasonably likely to predict the ultimate clinical benefit of a drug or
biologic.

The accelerated approval pathway
is most often used in settings in which the course of a disease is long and an extended period of time is required to measure the intended
clinical benefit of a drug, even if the effect on the surrogate or intermediate clinical endpoint occurs rapidly. For example, accelerated
approval has been used extensively in the development and approval of drugs for treatment of 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