Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 178

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 178
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 be reviewed within six months of filing. Despite these review goals, it is not uncommon for FDA review of an NDA or BLA to extend beyond
the goal date. For instance, the review process may be extended by the FDA for three additional months to consider new information or
clarification provided by the applicant to address an outstanding deficiency identified by the FDA following the original submission.

The FDA may refer applications
for novel drug or biological products or drug or biological products which present difficult questions of safety or efficacy to an advisory
committee, typically a panel that includes independent clinicians and other experts, for review, evaluation and a recommendation as to
whether the application should be approved and under what conditions. The FDA is not bound by the recommendations of an advisory committee,
but it considers such recommendations carefully when making decisions and typically follows the advisory committee’s recommendations.

Before approving an NDA, the
FDA typically will inspect the facility or facilities where the product is or will be manufactured. These pre-approval inspections cover
all facilities associated with an NDA or BLA submission, including drug or biologic component manufacturing (such as APIs), finished product
manufacturing, and control testing laboratories. The FDA will not approve an application unless it determines that the manufacturing processes
and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications.
Additionally, before approving an NDA, the FDA will typically inspect one or more clinical sites to assure compliance with GCP.

Fast Track, Breakthrough Therapy and Priority Review Designations

The FDA is authorized to designate certain products
for expedited review 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.

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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