Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 55

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 55
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 slow or unable to adapt to changes
in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we
may lose any marketing approval that we may have obtained, which would adversely affect our business, prospects and ability to achieve
or sustain profitability.

Obtaining and maintaining regulatory approval of any of our other product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions.

Obtaining and maintaining
regulatory approval of our other product candidates in one jurisdiction does not guarantee that we will be able to obtain or maintain
regulatory approval in any other jurisdiction, while a failure or delay in obtaining regulatory approval in one jurisdiction may have
a negative effect on the regulatory approval process in others. For example, even if the FDA grants marketing approval of a product candidate,
similar foreign regulatory authorities must also approve the manufacturing, marketing and promotion of the product candidate in those
countries. Approval and licensure procedures vary among jurisdictions and can involve requirements and administrative review periods different
from, and greater than, those in the United States, including additional nonclinical studies or clinical trials as clinical trials conducted
in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictions outside the United States,
a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price
that we intend to charge for our products is also subject to approval.

We may also submit marketing
applications in other countries. Regulatory authorities in jurisdictions outside of the United States have requirements for approval of
product candidates with which we must comply prior to marketing in those jurisdictions. Obtaining similar foreign regulatory approvals
and compliance with similar foreign regulatory requirements could result in significant delays, difficulties and costs for us and could
delay or prevent the introduction of our products in certain countries. We do not currently have any product candidates approved for sale
in any jurisdiction, including international markets, and we do not have experience in obtaining regulatory approval in international
markets. If we fail to comply with the regulatory requirements in international markets and/or receive applicable marketing approvals,
our target market will be reduced and our ability to realize the full market potential of our product candidates will be harmed.

We seek to establish agreements with potential licensing partners and collaborators and, if we are not able to establish them on commercially reasonable terms, we may have to alter our development and commercialization plans.

Our current development and
commercialization strategy is to deploy our proprietary