Company: SHPH
Filing Date: 2025-02-26
Form Type: 10-K
Source: 0001493152-25-008300
Chunk: 65

Company: Shuttle Pharmaceuticals Holdings, Inc.
Filing Date: 2025-02-26
Form: 10-K
Item: Item 1
Chunk 65
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 which they are administered according to
    accepted standards of medical practice; and

    ●
    they
    have been approved by the FDA and meet other requirements of the statute.

40

There
may be significant delays in obtaining coverage for newly-approved drugs, and coverage may be more limited than the purposes for which
the drug is approved by the FDA. Moreover, eligibility for coverage does not imply that any drug will be reimbursed in all cases or at
a rate that covers our costs, including research, development, manufacture, sale and distribution. Interim payments for new drugs, if
applicable, may also not be sufficient to cover our costs and may not be made permanent. Reimbursement may be based on payments allowed
for lower- cost drugs that are already reimbursed, may be incorporated into existing payments for other services and may reflect budgetary
constraints or imperfections in Medicare data. Net prices for drugs may be reduced by mandatory discounts or rebates required by government
healthcare programs or private payors and by any future relaxation of laws that presently restrict imports of drugs from countries where
they may be sold at lower prices than in the U.S. Third-party payors often rely upon Medicare coverage policy and payment limitations
in setting their own reimbursement rates. Our inability to promptly obtain coverage and adequate reimbursement rates from both government-funded
and private payors for new drugs that we develop and for which we obtain regulatory approval could have a material adverse effect on
our operating results, our ability to raise capital needed to commercialize products and our financial condition.

We
believe that the efforts of governments and third-party payors to contain or reduce the cost of healthcare and legislative and regulatory
proposals to broaden the availability of healthcare will continue to affect the business and financial condition of pharmaceutical and
biopharmaceutical companies. A number of legislative and regulatory changes in the healthcare system in the U.S. and other major healthcare
markets have been proposed in recent years, and such efforts have expanded substantially in recent years. These developments have included
prescription drug benefit legislation that was enacted and took effect in January 2006, healthcare reform legislation enacted by certain
states, and Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act
(the “ACA”), a sweeping law intended to broaden access to health insurance, reduce or constrain the growth of healthcare
spending and enhance remedies against fraud and abuse. The ACA also contains provisions that will affect companies in the pharmaceutical