Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 174

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 174
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 the case of some product candidates for severe or life-threatening diseases, especially 
 when the product candidate may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often       
 conducted in patients.                                                                                                                         |

| • | Phase 2. The product candidate is evaluated in a limited patient population to identify possible adverse effects and safety              
 risks, to preliminarily evaluate the efficacy of the product candidate for specific targeted diseases and to determine dosage tolerance, 
 optimal dosage and dosing schedule.                                                                                                      |

| • | Phase 3. Clinical trials are undertaken to further evaluate dosage, clinical efficacy, potency, and safety in an expanded                     
 patient population at geographically dispersed clinical trial sites. These clinical trials are intended to establish the overall risk/benefit 
 ratio of the product candidate and provide, if appropriate, an adequate basis for approval and product labeling. These trials may include     
 comparisons with placebo and/or other 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.

| 88 |

Progress reports detailing
the results of the clinical trials