Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 174

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 174
---
 subjects under the supervision of qualified investigators in accordance with GCP
requirements, which include, among other things, the requirement that all research subjects provide their informed consent in writing
before their participation in any clinical trial. Clinical trials are conducted under written study protocols detailing, among other things,
the inclusion and exclusion criteria, the objectives of the study, the parameters to be used in monitoring safety and the effectiveness
criteria to be evaluated. A protocol for each clinical trial and any subsequent protocol amendments must be submitted to the FDA as part
of the IND. An IND automatically becomes effective 30 days after receipt by the FDA, unless before that time the FDA raises concerns or
questions related to a proposed clinical trial and places the clinical trial on clinical hold. In such a case, the IND sponsor and the
FDA must resolve any outstanding concerns before the clinical trial can begin. Accordingly, submission of an IND may not result in the
FDA allowing clinical trials to commence. A separate submission to an existing IND must also be made for each successive clinical trial
conducted during development of a product candidate, and the FDA must grant permission, either explicitly in writing or implicitly by
not objecting, before each clinical trial can begin.

Following commencement of
a clinical trial, the FDA may also place a clinical hold or partial clinical hold on that trial. A clinical hold is an order issued by
the FDA to the sponsor to delay a proposed clinical investigation or to suspend an ongoing investigation. A partial clinical hold is a
delay or suspension of only part of the clinical work requested under the IND. No more than 30 days after imposition 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