Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 52

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 52
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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 a more restrictive label or the delay or denial of regulatory approval by the EMA, the MHRA, the FDA
or other comparable foreign regulatory authority. Results of the clinical trials could reveal a high and unacceptable severity and prevalence
of side effects or risks associated with a product candidate’s use. In such an event, our trials could be suspended or terminated
and the regulatory authorities could order us to cease further development of or deny approval of our product candidates for any or all
targeted indications. The drug-related side effects could affect patient recruitment to clinical trials for our product candidates or
the ability of enrolled subjects to complete the trial or result in potential product liability claims. Any of these occurrences may harm
our business, financial condition and prospects significantly.

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Additionally, if undesirable
side effects of our products are identified following marketing approval, a number of potentially significant negative consequences could
result, including:

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