Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 49

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 49
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 European Union and in the United Kingdom, could depress our economic activity
and restrict our access to capital, which could have a material adverse effect on our business, financial condition and results of operations
and reduce the price of our Ordinary Shares and Depositary Shares.

| 26 |

The regulatory approval processes in the United States and Europe are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, our business may be substantially harmed.

The time required to obtain
approval for a product candidate by the EMA, the MHRA, the FDA and other comparable foreign regulatory authorities is unpredictable, and
it typically takes many years following the commencement of preclinical studies and clinical trials, if approval is obtained at all, and
depends upon numerous factors, including the substantial discretion of the regulatory authorities. In addition, approval policies, regulations,
or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical
development and may vary among jurisdictions. We have not obtained regulatory approval for any product candidate, and it is possible that
we may never obtain regulatory approval for any product candidate we may seek to develop in the future. Neither we nor any current or
future collaborator is permitted to market any drug product candidates in the United States until we receive regulatory approval of a
NDA from the FDA, and we cannot market it in the European Union or the United Kingdom until we receive a marketing authorization approval
from the EMA or the MHRA, respectively, or in any other country until we obtain regulatory authorization as required under the laws of
such country.

Our product candidates could
fail to receive regulatory approval from the EMA, the MHRA, the FDA and other comparable foreign regulatory authorities for many reasons,
including:

| • | disagreement with the design or implementation of the clinical trials; |

| • | failure to demonstrate that a product candidate is safe and effective for its proposed indication; |

| • | failure of clinical trial results to meet the level of statistical significance required for approval; |

| • | failure to demonstrate that a product candidate’s clinical and other benefits outweigh its safety 
 risks;                                                                                            |

| • | disagreement with our interpretation of data from preclinical studies or clinical trials; |

| • | the insufficiency of data collected from clinical trials of our product candidates to support the submission 
 and filing of a NDA, BLA, MAA or other submission or to obtain regulatory approval;                          |

| • | regulatory authorities may