Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 180

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 180
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 or more of these programs, the FDA may later decide that the product no longer meets the conditions for qualification or decide
that the time period for FDA review or approval will not be shortened. Furthermore, fast track designation, breakthrough therapy designation,
and priority review do not change the scientific or medical standards for approval or the quality of evidence necessary to support approval
and may not ultimately expedite the development or review process.

Accelerated Approval Pathway

The FDA may grant accelerated
approval to a drug or biologic for a serious or life-threatening condition that provides meaningful therapeutic advantage to patients
over existing treatments based upon a determination from well-controlled clinical trials that the drug has an effect on a surrogate endpoint
that is reasonably likely to predict clinical benefit. The FDA may also grant accelerated approval for such a drug or biologic when the
product has an effect on an intermediate clinical endpoint that can be measured earlier than an effect on irreversible morbidity or mortality,
or IMM, and that is reasonably likely to predict an effect on IMM or other clinical benefit, taking into account the severity, rarity,
or prevalence of the condition and the availability or lack of alternative treatments. Drugs and biologics granted accelerated approval
must meet the same statutory standards for safety and effectiveness as those granted traditional approval.

For the purposes of accelerated
approval, a surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign, or other measure that
is thought to predict clinical benefit, but is not itself a measure of clinical benefit. Surrogate endpoints can often be measured more
easily or more rapidly than clinical endpoints. An intermediate 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