Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 41

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 41
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, to the
FDA, as well as clinical trial applications, or CTAs, or marketing authorization applications, or MAAs, to the EMA. eRapa, Tolimidone
and MTX110 are both at a relatively early stage in their clinical development. There can be no assurance that the FDA will permit any
of our future NDAs, BLAs, or INDs, including the NDA for eRapa, tolimidone or MTX110 or any future INDs for our other product candidates,
to go into effect in a timely manner or at all. Without an IND or CTA for a product candidate, we will not be permitted to conduct clinical
trials in the United States or the European Union, respectively, of such product candidate.

Drug
or biological product development is a difficult, long, time-consuming, expensive and uncertain process, and delay or failure can occur
at any stage of any of our clinical trials. Failure to obtain regulatory approval for our product candidates will prevent us from commercializing
and marketing them. Clinical trials may be delayed, suspended or prematurely terminated for a variety of reasons, such as:

| • | delay or failure to complete preclinical studies; |

| • | insufficient financial and other resources to complete the necessary preclinical studies and clinical 
 trials;                                                                                               |

| • | delay or failure in reaching agreement with the applicable regulatory authorities on a trial design; |

| • | delay or failure in obtaining authorization to commence a trial or inability to comply with conditions 
 imposed by a regulatory authority regarding the scope or design of a clinical trial;                   |

| • | delay or failure in reaching agreement on acceptable terms with prospective contract research organizations,                           
 or CROs, and clinical trial providers and sites, the terms of which can be subject to extensive negotiation and may vary significantly 
 among different CROs and trial sites;                                                                                                  |

| • | delay or failure in obtaining institutional review board, or IRB, approval or the approval of other reviewing 
 entities, including foreign regulatory authorities, to conduct a clinical trial at each site;                 |

| • | failure to recruit, or subsequent withdrawal of, clinical trial sites from clinical trials as a result 
 of changing standards of care or the ineligibility of a site to participate in our clinical trials;    |

| • | delay or failure in recruiting and enrolling suitable subjects to participate in a trial; |

| • | delay or failure in having subjects complete a trial or return for post-treatment follow-up;