Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 87

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 87
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 trials
is conducted in accordance with the applicable protocol and legal, regulatory and scientific standards, and our reliance on the CROs or
collaboration partners does not relieve us of our regulatory responsibilities. We also rely on third parties to assist in conducting our
preclinical studies in accordance with good laboratory practices, or GLP, and requirements with respect to animal welfare. We and our
CROs or collaboration or licensing partners are required to comply with GCP, which are regulations and guidelines enforced by the MHRA,
the FDA, the EMA and comparable foreign regulatory authorities for all of our products in clinical development. Regulatory authorities
enforce GCP regulations, and other regulations applicable to clinical trials and investigational drug or biological products, through
periodic inspections of trial sponsors, CROs, principal investigators and trial sites. If we or any of our CROs or partners fail to comply
with applicable GCP regulations or other clinical trial regulations, the data generated in our clinical trials may be deemed unreliable
and the EMA, the MHPA, the FDA or comparable foreign regulatory authorities may require us to perform additional clinical trials before
approving our marketing applications. We cannot be assured that upon inspection by a given regulatory authority, that such regulatory
authority will determine that any of our clinical trials comply with GCP requirements or other applicable regulations. In addition, our
clinical trials must be conducted with product produced under cGMP requirements. Failure to comply with these regulations may require
us to repeat preclinical and clinical trials, which would delay the regulatory approval process.

Our CROs and other contractors
or collaborators are not our employees, and except for remedies available to us under such agreements with such CROs, we cannot control
whether or not they devote sufficient time and resources to our on-going or future clinical or nonclinical programs, as applicable. If
CROs do not successfully carry out their contractual duties or obligations or meet expected deadlines or if the quality or accuracy of
the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols, regulatory requirements or for other
reasons, then our clinical trials may be extended, delayed or terminated and we may not be able to obtain regulatory approval for or successfully
commercialize our product candidates. As a result, our results of operations and the commercial prospects for our product candidates would
be harmed, our costs could increase and our ability to generate revenues could be delayed.

If any of our relationships
with these third parties terminate,