Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 173

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 173
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 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 adverse events and carcinogenicity, may continue after
the IND is submitted.

The Consolidated Appropriations
Act for 2023, signed into law on December 29, 2022, (P.L. 117-328) amended the FDCA and the Public Health Service Act to specify that
nonclinical testing for drugs and biologics may, but is not required to, include in vivo animal testing. According to the amended
language, a sponsor may fulfill nonclinical testing requirements by completing various in vitro assays (e.g., cell-based assays,
organ chips, or microphysiological systems), in silico studies (i.e., computer modeling), other human or nonhuman biology-based
tests (e.g., bioprinting), or in vivo animal tests.

| 87 |

Human Clinical Trials in Support of an NDA

Clinical trials involve the
administration of the investigational product to human