Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 179

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 179
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 submitted by the sponsor, that a fast track product may be effective. The sponsor must also provide, and the
FDA must approve, a schedule for the submission of the remaining information and the sponsor must pay applicable user fees upon submission
of the first section of the NDA or BLA. However, the FDA’s time period goal for reviewing a fast track application does not begin
until the last section of the NDA is submitted. In addition, the fast track designation may be withdrawn by the FDA if the FDA believes
that the designation is no longer supported by data emerging in the clinical trial process.

The FDA may grant breakthrough
therapy designation to a drug or biologic meeting certain statutory criteria upon a request made by the IND sponsor. A product may be
designated as a breakthrough therapy if it is intended, either alone or in combination with one or more other drugs, to treat a serious
or life-threatening disease or condition and preliminary clinical evidence indicates that the product may demonstrate substantial improvement
over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical
development. The FDA may take certain actions with respect to breakthrough therapies, including holding meetings with the sponsor throughout
the development process; providing timely advice to the product sponsor regarding development and approval; involving more senior staff
in the review process; assigning a cross-disciplinary project lead for the review team; and taking other steps to design the clinical
trials in an efficient manner. In addition, breakthrough therapies are eligible for accelerated approval of their respective marketing
applications.

The FDA may designate a product
for priority review if 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