Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 175

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 175
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 must be submitted at least annually to the FDA and more frequently if serious adverse events occur.
In addition, IND safety reports must be submitted to the FDA for any of the following: serious and unexpected suspected adverse reactions;
findings from other studies or animal or in vitro testing that suggest a significant risk in humans exposed to the drug; and any
clinically important increase in the case of a serious suspected adverse reaction over that listed in the protocol or investigator brochure.
Phase 1, Phase 2 and Phase 3 clinical trials may not be completed successfully within any specified period, or at all. Furthermore, the
FDA or the sponsor may suspend or terminate a clinical trial at any time on various grounds, including a finding that the research subjects
are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution,
or an institution it represents, if the clinical trial 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