Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 171

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 171
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 effect before human clinical trials may begin; |

| • | approval of clinical protocols by an independent institutional review board, or IRB, or ethics committee representing each clinical 
 site before each site may enroll subjects;                                                                                          |

| • | potential initiation and completion of successive clinical trials that establish safety dose ranges; |

| • | performance of adequate and well-controlled human clinical trials in accordance with good clinical practices, or GCP, and other clinical-trial 
 related regulations to establish the safety and efficacy of the proposed drug product for each indication;                                     |

| • | preparation and submission to the FDA of a new drug application, or NDA, or a biologics license application, or BLA; |

| • | review of the submission by an FDA advisory committee, where appropriate or if applicable; |

| • | satisfactory completion of one or more FDA inspections of the manufacturing facility or facilities at which the product, or components 
 thereof, are produced to assess compliance with cGMP requirements and to assure that the facilities, methods and controls are adequate 
 to preserve the product’s identity, strength, quality and purity;                                                                      |

| • | satisfactory completion of FDA audits of clinical trial sites to assure compliance with GCPs and the integrity of the clinical data; |

| • | payment of user fees and securing FDA approval of the NDA or BLA; |

| • | agree to comply with any post-approval requirements, including Risk Evaluation and Mitigation Strategies, or REMS, and post-approval 
 studies required by the FDA; and                                                                                                     |

| • | FDA review and approval of the NDA or licensure of the BLA. |

Preclinical Studies

Preclinical studies include
laboratory evaluation of the purity and stability of the manufactured drug substance or API and the formulated finished drug or drug product,
as well as in vitro and animal studies to assess the safety and activity of the drug for initial testing in humans and to establish
a rationale for therapeutic use. The conduct of preclinical studies is subject to federal and state regulations and requirements, including
GLP regulations. The results of the preclinical tests, together with manufacturing information, analytical data, any available clinical
data or literature and plans for clinical trials, among other things, are submitted to the FDA as part of an IND. An IND is a request
for authorization from the FDA to administer an investigational product to humans and must become effective before human clinical trials
may begin. Some long-term nonclinical testing, such as animal tests of reproductive