Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 58

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 58
---
 more rapidly than we are able to or may obtain patent protection of other
intellectual property rights that limit our ability to develop or commercialize our product candidates. Our competitors may also develop
products that are more effective, more widely used and less costly than our own product candidates, and may be more successful in commercializing
their products.

We anticipate that we will
face increased competition in the future as new companies enter our markets and alternative products and technologies become available.
Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among
a smaller number of our competitors. Smaller and other early-stage companies may also prove to be significant competitors, particularly
through collaborative arrangements with large and established companies. These third parties compete with us in recruiting and retaining
qualified scientific, management and commercial personnel, as well as in acquiring technologies complementary to, or necessary for, our
programs.

Changes in healthcare policies, laws and regulations, including legislative measures aimed at reducing health care costs, may impact our ability to obtain approval for or commercialize any of our future product candidates, if approved.

All aspects of our business,
including research and development, manufacturing, marketing, pricing, sales, litigation, and intellectual property rights, are subject
to extensive legislation and regulation. Changes in applicable U.S. federal and state laws and agency regulation, as well as foreign laws
and regulations, could have a materially negative impact on our business. In the United States and in some other jurisdictions, there
have been a number of legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay
marketing approval of our product candidates or any potential future product candidates of ours, restrict or regulate post-approval activities,
or affect our ability to profitably sell any product candidates for which we obtain marketing approval. Increased scrutiny by the U.S.
Congress of the FDA’s approval process may significantly delay or prevent marketing approval, as well as subject us to more stringent
product labeling and post-marketing testing and other requirements. Congress also must reauthorize the FDA’s user fee programs every
five years and often makes changes to those programs in addition to policy or procedural changes that may be negotiated between the FDA
and industry stakeholders as part of this periodic reauthorization process. Congress most recently reauthorized the user fee programs
in September 2022 without any substantive policy changes.

| 31 |

Among policy makers and payors
in the United States and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals