Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 172

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 172
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 forth herein do and will apply to
us, some are more applicable to any licensing partner who seeks to conduct clinical trials of, obtain regulatory approval for and commercialize
any of our product candidates, which could have an impact on any licensing revenue received by us.

Review and Approval of Drugs in the United States

In the United States, the
FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act, or the FDCA, and implementing regulations. Failure to comply with
the applicable United States requirements at any time during the product development process, approval process or after approval may subject
an applicant and/or sponsor to a variety of administrative or judicial sanctions, including refusal by the FDA to approve pending applications,
withdrawal of an approval, imposition of a clinical hold, issuance of warning letters and other types of enforcement letters, product
recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts,
restitution, disgorgement of profits, exclusion from participation in government sponsored healthcare programs such as Medicare, or civil
or criminal investigations and penalties brought by the FDA and the Department of Justice, or the DOJ, or other governmental entities.

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An applicant seeking approval to market and distribute
a new drug product in the United States must typically undertake the following:

| • | completion of preclinical (or nonclinical) laboratory tests, animal studies and formulation studies in compliance with the FDA’s 
 good laboratory practice, or GLP, regulations;                                                                                   |

| • | submission to the FDA of an IND application, which must take 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