Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 51

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 51
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 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.

| 27 |

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

| • | marketing of such product may be suspended; |

| • | a product recall or product withdrawal; |

| • | regulatory authorities may withdraw approvals of such product or may require additional warnings on the 
 label;                                                                                                  |

| • | the requirement to develop a REMS for each product or, if a strategy is already in place, to incorporate                           
 additional requirements under the REMS, or to develop a similar strategy as required by a comparable foreign regulatory authority; |

| • | the requirement to conduct additional post-market studies; and |

| • | being sued and held liable for harm caused to subjects or patients. |

Consequently, our reputation and business operations
may suffer.

Any of these events could
prevent the achievement or maintaining of market acceptance of the particular product or product candidate, if approved, and could significantly
harm our business, results of operations and prospects.

Even if we receive regulatory approval of any product candidates, we will be subject to ongoing regulatory oversight and continued regulatory review, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with any of our product candidates.

Our product candidates, if
they receive regulatory approval, will be subject to the ongoing requirements of the EMA, the MHRA, the FDA and other regulatory agencies
governing the manufacture, quality control, further development, labeling, packaging, storage, distribution, safety surveillance, import,
export, advertising, promotion, recordkeeping and reporting of safety and other post-market information. These requirements include submissions
of safety and other post-marketing information and