Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 178

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 178
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 it is a drug that treats a serious condition and, if approved, would provide a significant improvement in safety
or effectiveness. The FDA determines, at the time that the marketing application is submitted, on a case-by-case basis, whether the proposed
drug represents a significant improvement when compared with other available therapies. Significant improvement may be illustrated by
evidence of increased effectiveness in the treatment of a condition, elimination or substantial reduction of a treatment-limiting drug
reaction, documented enhancement of patient compliance that may lead to improvement in serious outcomes, or evidence of safety and effectiveness
in a new subpopulation. A priority designation is intended to direct overall attention and resources to the evaluation of such applications,
and to shorten the FDA’s goal for taking action on a marketing application from ten months to six months for an original BLA or
for an NME NDA from the date of filing.

Even if a product qualifies
for one 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