Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 177

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 177
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 is not being conducted in accordance with the IRB’s requirements or if the
drug has been associated with unexpected serious harm to patients. The FDA will typically inspect one or more clinical sites to assure
compliance with GCP and the integrity of the clinical data submitted with an NDA or BLA.

Submission of an NDA or BLA to the FDA

Assuming successful completion
of required clinical testing and other requirements, the results of the preclinical studies and clinical trials, together with detailed
information relating to the product’s chemistry, manufacture, controls and proposed labeling, among other things, are submitted
to the FDA as part of an NDA or BLA requesting approval to market the product candidate for one or more indications. Data may come from
company-sponsored clinical trials intended to test the safety and effectiveness of a use of a product, or from a number of alternative
sources, including studies initiated by investigators. To support marketing approval, the data submitted must be sufficient in quality
and quantity to establish the safety and effectiveness of the investigational drug product to the satisfaction of the FDA. In particular,
a BLA must contain proof of the biological product candidate’s safety, purity, potency and efficacy for its proposed indication
or indications. Under federal law, the submission of most NDAs is additionally subject to a substantial application user fee, and the
sponsor of an approved NDA is also subject to an annual program user fee. These fees are typically increased annually. Certain exceptions
and waivers are available for some of these fees, such as an exception from the application fee for products with orphan designation and
a 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