Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 180

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 180
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 product.

The FDA’s Decision on an NDA or BLA

The FDA reviews an NDA to
determine, among other things, whether a product is safe and effective for its intended use and whether its manufacturing is cGMP-compliant
to assure and preserve the product’s identity, strength, quality and purity. The FDA reviews a BLA to determine, among other things
whether the product is safe, pure and potent and the facility in which it is manufactured, processed, packed or held meets standards designed
to assure the product’s continued safety, purity and potency. The approval process is lengthy and often difficult, and the FDA may
refuse to approve an NDA or BLA if the applicable regulatory criteria are not satisfied or may require additional clinical or other data
and information. On the basis of the FDA’s evaluation of the NDA and accompanying information, including the results of the inspection
of the manufacturing facilities, the FDA may issue an approval letter or a complete response letter. An approval letter authorizes commercial
marketing of the product with specific prescribing information for specific indications. A complete response letter indicates that the
review cycle of the application is complete and the application will not be approved in its present form. A complete response letter generally
outlines the deficiencies in the submission and may require substantial additional testing or information in order for the FDA to reconsider
the application. If and when those deficiencies have been addressed to the FDA’s satisfaction in a resubmission of the NDA or BLA,
the FDA will issue an approval letter. The FDA has committed to reviewing such resubmissions in two or six months depending on the type
of information included. Even with submission of this additional information, the FDA ultimately may decide that the application does
not satisfy the regulatory criteria for approval.

If the FDA approves a product,
it may limit the approved indications for use for the product, require that contraindications, warnings or precautions be included in
the product labeling, require that post-approval studies, including Phase 1V clinical trials, be conducted to further assess the drug’s
safety after approval, require testing and surveillance programs to monitor the product after commercialization, or impose other conditions,
including distribution restrictions or other risk management mechanisms, such as REMS, which can materially affect the potential market
and profitability of the product. The FDA may prevent or limit further marketing of a product based on the results of post-market studies
or surveillance programs. The FDA may also require an applicant to develop a REM