Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 50

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 50
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 find deficiencies in good clinical practice, or GCP, compliance or may find 
 our record keeping, or the record keeping of our clinical trial sites, to be inadequate;               |

| • | disapproval of the manufacturing processes or facilities of third party manufacturers with whom we or 
 any licensing partner contracts with for clinical and commercial supplies; or                         |

| • | changes in approval policies or regulations that render the preclinical and clinical data insufficient 
 for approval.                                                                                          |

Of the large number of products
in development, only a small percentage successfully complete the FDA, EMA, MHRA, or other comparable regulatory approval processes and
are commercialized. The lengthy approval and marketing authorization process as well as the unpredictability of future clinical trial
results may result in our failing to obtain regulatory approval and marketing authorization to market our product candidates, which would
significantly harm our business, financial condition, results of operations and prospects.

In addition, the EMA, the
MHRA, the FDA and other comparable foreign regulatory authorities may require more information, including additional preclinical or clinical
data to support approval, which may delay or prevent approval and any commercialization plans, or we or any licensing partner may decide
to abandon the development program. If approval were to be obtained, regulatory authorities may approve any of our product candidates
for fewer or more limited indications than is requested, may grant approval contingent on the performance of costly post-marketing clinical
trials, or may approve a product candidate with a label that does not include the labeling claims necessary or desirable for the successful
commercialization of that product candidate. In addition, if our product candidate produces undesirable side effects or safety issues,
the regulatory authorities (the FDA, MHRA, EMA or a comparable foreign regulatory authority) may require the establishment of Risk Evaluation
and Mitigation Strategy, or REMS, which may, for instance, restrict distribution of the products and impose burdensome implementation
requirements on us or any licensing partner. Any of the foregoing scenarios could materially harm the commercial prospects for our product
candidates.

Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval and limit the commercial profile of an approved label, and such side effects or other properties could result in significant negative consequences following any marketing approval of any of our product candidates.

Undesirable side effects caused
by any of our product candidates could cause us, our licensing partners, if any, or regulatory authorities to interrupt, delay or halt
clinical trials and could result in