Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 47

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 47
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. Trial subject enrollment is affected by other factors including:

| • | the severity and difficulty of diagnosing the disease under investigation; |

| • | the eligibility and exclusion criteria for the trial in question; |

| • | the size of the patient population and process for identifying patients; |

| • | our ability to recruit clinical trial investigators with the appropriate competencies and experience; |

| • | the design of the trial protocol; |

| • | the perceived risks and benefits of the product candidate in the trial in relation to other available 
 therapies, including any new products that may be approved for the indications we are investigating;  |

| 25 |

| • | the availability of competing commercially available therapies and other competing therapeutic candidates’ 
 clinical trials for the disease or condition under investigation;                                          |

| • | the willingness of patients to be enrolled in our clinical trials; |

| • | the risk that subjects enrolled in 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