Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 176

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 176
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 waiver of the application fee for the first application filed by a qualifying small business.

The FDA conducts a preliminary
review of an NDA within 60 days of its receipt and informs the sponsor by the 74th day after the FDA’s receipt of the submission
whether the application is sufficiently complete to permit substantive review. The FDA may request additional information rather than
accept an NDA for filing. In this event, the application must be resubmitted with the additional information. The resubmitted application
is also subject to review before the FDA accepts it for filing. Once the submission is accepted for filing, the FDA begins an in-depth
substantive review. The FDA has agreed to specified performance goals in the review process of NDAs and BLAs. Most such applications are
meant to be reviewed within ten months from the date of filing, and most applications for “priority review” products are meant
to 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