Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 176

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 176
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 comparator treatments. The duration of treatment is often extended to mimic the actual use of a         
 product during marketing.                                                                                                                     |

Post-approval clinical trials,
sometimes referred to as Phase 4 clinical trials, may be conducted after initial marketing approval. These clinical trials are used to
gain additional experience from the treatment of patients in the intended therapeutic indication, particularly for long-term safety follow-up.
In certain instances, the FDA may mandate the performance of Phase 4 clinical trials as a condition of approval of an NDA or BLA.

In the Consolidated Appropriations
Act for 2023, Congress amended the FDCA to require sponsors of a Phase 3 clinical trial, or other “pivotal study” of a new
drug to support marketing authorization, to submit a diversity action plan for such clinical trial. The action plan must include the sponsor’s
diversity goals for enrollment, as well as a rationale for the goals and a description of how the sponsor will meet them. A sponsor must
submit a diversity action plan to FDA by the time the sponsor submits the trial protocol to the agency for review. The FDA may grant a
waiver for some or all of the requirements for a diversity action plan. It is unknown at this time how the diversity action plan may affect
Phase 3 trial planning and timing or what specific information FDA will expect in such plans, but if FDA objects to a sponsor’s
diversity action plan and requires the sponsor to amend the plan or take other actions, it may delay trial initiation.

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Progress reports detailing
the results of the clinical trials 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