Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 50

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 50
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, 2020, commonly referred to as Brexit. Pursuant to the formal
withdrawal arrangements agreed between the United Kingdom and the European Union, the United Kingdom was subject to a transition period
until December 31, 2020, during which European Union rules continued to apply. The Trade and Cooperation Agreement between the United
Kingdom and the European Union, which outlines the future trading relationship between the United Kingdom and the European Union, was
agreed in December 2020. The impact of the new trade agreement on the general and economic conditions in the United Kingdom remains uncertain.
There may be, for example, additional costs in materials and equipment sourced from the European Union and/or delays that could have a
material adverse effect on our business, financial condition and results of operations.

From a regulatory perspective,
the United Kingdom’s withdrawal from the European Union could bear significant complexity and risks. A basic requirement of
European Union law relating to the grant of a marketing authorization for a medicinal product in the European Union is that the applicant
is established in the European Union. Following the withdrawal of the United Kingdom from the European Union, marketing authorizations
previously granted to applicants established in the United Kingdom may no longer be valid. Moreover, the scope of a marketing authorization
for a medicinal product granted by the European Commission pursuant to the centralized procedure might not, in the future, include the
United Kingdom. In these circumstances, an authorization granted by competent United Kingdom authorities would be required to place medicinal
products on the United Kingdom market.

Any of these factors could
significantly increase the complexity of our activities in the 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.

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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