Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 49

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 49
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 clinical trials will drop out of our trials before completion; |

| • | our ability to obtain and maintain clinical trial subject informed consents |

| • | the efforts to facilitate timely enrollment in clinical trials; |

| • | the patient referral practices of physicians; |

| • | the ability to monitor patients adequately during and after treatment; and |

| • | the proximity and availability of clinical trial sites for prospective patients. |

In addition, the U.S. Congress
recently amended the FDCA to require sponsors of a Phase 3 clinical trial, or other “pivotal study” of a new drug or biologic
to support marketing authorization, to design and submit a diversity action plan for such clinical trial. The action plan must describe
appropriate diversity goals for enrollment, as well as a rationale for the goals and a description of how the sponsor will meet them.
Although none of our product candidates has reached Phase 3 of clinical development, we or our licensing partners must submit a diversity
action plan to the FDA by the time a Phase 3 trial, or pivotal study, protocol is submitted to the agency for review, unless we or our
licensing partners are able to obtain 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 the planning and timing of any future Phase 3 trial for our product candidates or what specific
information FDA will expect in such plans. However, initiation of such trials may be delayed if the FDA objects to a proposed diversity
action plans for any future Phase 3 trial of our product candidates, and we or our licensing partners may experience difficulties recruiting
a diverse population of patients in attempting to fulfill the requirements of any approved diversity action plan.

Inability to enroll a sufficient
number of patients for clinical trials would result in significant delays and could require us to abandon one or more clinical trials
altogether. Enrollment delays in these clinical trials may result in increased development costs for our product candidates, which would
cause the value of our company to decline and limit our ability to obtain additional financing. Furthermore, we expect to rely on CROs
and clinical trial sites to ensure the proper and timely conduct of our clinical trials and we will have limited influence over their
performance.

We are exposed to political, regulatory, social and economic risk relating to the United Kingdom’s exit from the European Union.

Following the result of a
referendum in 2016, the United Kingdom left the European Union on January 31