Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 177

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 177
---
 if they are intended to address an unmet medical need in the treatment of a serious or life-threatening disease or
condition. These programs are fast track designation, breakthrough therapy designation and priority review designation.

| 89 |

Specifically, the FDA may
designate a product for fast track review if it is intended, whether alone or in combination with one or more other drugs, for the treatment
of a serious or life-threatening disease or condition, and it demonstrates the potential to address unmet medical needs by providing a
therapy where none exists or a therapy that may be potentially superior to existing therapy based on efficacy or safety factors. For fast
track products, sponsors may have more frequent interactions with the FDA and the FDA may initiate review of sections of a fast track
product’s NDA or BLA before the application is complete. This rolling review may be available if the FDA determines, after preliminary
evaluation of clinical data 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 In addition, the fast track designation may be withdrawn by the FDA if the FDA believes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