Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 51

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 51
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 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 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