Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 170

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 170
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 data and trade secrets by maintaining physical security of our premises and
physical and electronic security of our information technology systems.

Government Regulations

Government authorities in
the United States, at the federal, state and local level, and in other countries and jurisdictions, including the European Union and the
United Kingdom, extensively regulate, among other things, the research, development, testing, manufacture, quality control, approval,
packaging, storage, recordkeeping, labeling, advertising, promotion, distribution, marketing, post-approval monitoring and reporting,
and import and export of pharmaceutical products. The processes for obtaining regulatory approvals in the United States and in foreign
countries and jurisdictions, along with subsequent compliance with applicable statutes and regulations and other regulatory authorities,
require the expenditure of substantial time and financial resources. As we have disclosed herein, we are seeking to license our product
candidates and other formulations to licensing partners. While many of the rules and regulations set 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.

| 86 |

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