Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 43

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 43
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 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; |

| • | clinical sites and investigators deviating from trial protocol, failing to conduct the trial in accordance 
 with regulatory requirements, or dropping out of a trial;                                                  |

| 22 |

| • | inability to identify and maintain a sufficient number of trial sites, many of which may already be engaged 
 in other clinical trial programs, including some that may be for the same indication;                       |

| • | failure of third party clinical trial managers or clinical sites to satisfy contractual duties or meet 
 expected deadlines;                                                                                    |

| • | delay or failure in adding new clinical trial sites; |

| • | ambiguous or negative interim results, or results that are inconsistent with earlier results; |

| • | the need for clinical trial protocol modifications based on comments from the EMA, the MHRA, the FDA,                                         
 a responsible IRB, a data safety monitoring boards, or other regulatory authority, or on results from earlier