Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 208

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 208
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 required to obtain the FDA approvals. Our product candidate
may not be considered medically necessary or cost-effective. A payor's decision to provide coverage for a drug product does not imply
that an adequate reimbursement rate will be approved. Further, one payor’s determination to provide coverage for a drug product
does not assure that other payors will also provide coverage for the drug product. Adequate third-party reimbursement may not be available
to enable us to maintain price levels sufficient to realize an appropriate return on our investment in drug development. Legislative proposals
to reform healthcare or reduce costs under government insurance programs may result in lower reimbursement for our products and product
candidate or exclusion of our product candidate from coverage. The cost containment measures that healthcare payors and providers are
instituting and any healthcare reform could significantly reduce our revenues from the sale of any approved product candidates. We cannot
provide any assurances that we will be able to obtain and maintain third-party coverage or adequate reimbursement for our product candidate
in whole or in part.

Healthcare Reform

In the United States and some
foreign jurisdictions, there have been, and continue to be, several legislative and regulatory changes and proposed changes regarding
the healthcare system that could prevent or delay marketing approval of product and therapeutic candidates, restrict or regulate post-approval
activities, and affect the ability to profitably sell product and therapeutic candidates that obtain marketing approval. The FDA’s
and other regulatory authorities’ policies may change and additional government regulations may be enacted that could prevent, limit
or delay regulatory approval of our product and therapeutic candidates. If we are 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 otherwise may have obtained and we may not achieve or sustain profitability, which would adversely affect our business, prospects,
financial condition and results of operations.

In addition, the containment
of healthcare costs has become a priority of federal and state governments and the prices of therapeutics have been a focus in this effort.
The U.S. government, state legislatures and foreign governments have shown significant interest in implementing cost-containment programs
to limit the growth of government-paid healthcare costs, including price controls, restrictions on reimbursement, and requirements for
substitution of generic and biosimilar products for branded prescription medicines and biologics, respectively. In recent years, the U.S.
Congress has considered reductions in Medicare reimbursement levels for medicines administered by physicians. CMS, the agency that