Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 173

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 173
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 of a clinical hold
or partial clinical hold, the FDA will provide the sponsor a written explanation of the basis for the hold. Following issuance of a clinical
hold or partial clinical hold, an investigation may only resume after the FDA has notified the sponsor that the investigation may proceed.

In addition, an IRB representing
each institution participating in the clinical trial must review and approve the plan for any clinical trial before it commences at that
institution, and the IRB must conduct a continuing review and reapprove the study at least annually. The IRB must review and approve,
among other things, the study protocol and informed consent information to be provided to study subjects. An IRB must operate in compliance
with FDA regulations.

Some trials are overseen by
an independent group of qualified experts organized by the trial sponsor, known as a data safety monitoring board or committee, or DSMB.
This group provides authorization as to whether or not a trial may move forward at designated check points based on access that only the
group maintains to available data from the study.

Information about certain
clinical trials, including details of the protocol and eventually study results, must be submitted within specific timeframes to the National
Institutes of Health, or NIH, for public dissemination on their ClinicalTrials.gov website. Information related to the product, patient
population, phase of investigation, study sites and investigators and other aspects of the clinical trial is made public as part of the
registration of the clinical trial. Sponsors are also obligated to disclose the results of their clinical trials after completion. Disclosure
of the results of these trials can be delayed in some cases for up to two years after the date of completion of the trial. Failure to
timely register a covered clinical study or to submit study results as provided for in the law can give rise to civil monetary penalties
and also prevent the non-compliant party from receiving future grant funds from the federal government. The U.S. Department of Health
and Human Services’ Final Rule and NIH’s complementary policy on ClinicalTrials.gov registration and reporting requirements
became effective in 2017, and both NIH and FDA have brought enforcement actions against non-compliant clinical trial sponsors.

Human clinical trials are typically conducted in
three sequential phases, Phase 1, Phase 2 and Phase 3, which may overlap or be combined:

| • | Phase 1. The product candidate is initially introduced into healthy human subjects and tested for safety, dosage tolerance,                    
 absorption, metabolism, distribution and excretion. In