Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 175

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 175
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 or not a trial may move forward at designated check points based on access that only the
group maintains to available data from the study.

Information about certain
clinical trials, including details of the protocol and eventually study results, must be submitted within specific timeframes to the National
Institutes of Health, or NIH, for public dissemination on their ClinicalTrials.gov website. Information related to the product, patient
population, phase of investigation, study sites and investigators and other aspects of the clinical trial is made public as part of the
registration of the clinical trial. Sponsors are also obligated to disclose the results of their clinical trials after completion. Disclosure
of the results of these trials can be delayed in some cases for up to two years after the date of completion of the trial. Failure to
timely register a covered clinical study or to submit study results as provided for in the law can give rise to civil monetary penalties
and also prevent the non-compliant party from receiving future grant funds from the federal government. The U.S. Department of Health
and Human Services’ Final Rule and NIH’s complementary policy on ClinicalTrials.gov registration and reporting requirements
became effective in 2017, and both NIH and FDA have brought enforcement actions against non-compliant clinical trial sponsors.

Human clinical trials are typically conducted in
three sequential phases, Phase 1, Phase 2 and Phase 3, which may overlap or be combined:

| • | Phase 1. The product candidate is initially introduced into healthy human subjects and tested for safety, dosage tolerance,                    
 absorption, metabolism, distribution and excretion. In 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