Company: SHPH
Filing Date: 2025-02-26
Form Type: 10-K
Source: 0001493152-25-008300
Chunk: 229

Company: Shuttle Pharmaceuticals Holdings, Inc.
Filing Date: 2025-02-26
Form: 10-K
Item: Item 1A
Chunk 229
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 testing, development,
manufacturing, safety, efficacy, approval, recordkeeping, reporting, labeling, storage, packaging, advertising and promotion, pricing,
marketing and distribution of drugs. Rigorous preclinical testing and clinical trials and an extensive regulatory approval process are
required to be completed in the U.S. and in many foreign jurisdictions before a new drug can be marketed. Satisfaction of these and other
regulatory requirements is costly, time-consuming, uncertain and subject to unanticipated delays. It is possible that none of the product
candidates we may develop will obtain the regulatory approvals necessary for us or our collaborators to begin selling them.

We
have very limited experience in conducting and managing the clinical trials necessary to obtain regulatory approvals, including approval
by the FDA. The time required to obtain FDA and other approvals is unpredictable but typically takes many years following the commencement
of clinical trials, depending upon the type, complexity and novelty of the product candidate. The standards that the FDA and its foreign
counterparts use when regulating us are not always applied predictably or uniformly and can change. Any analysis we perform of data from
preclinical and clinical activities is subject to confirmation and interpretation by regulatory authorities, which could delay, limit
or prevent regulatory approval. We may also encounter unexpected delays or increased costs due to new government regulations, for example,
from future legislation or administrative action, or from changes in FDA policy during the period of product development, clinical trials
and FDA regulatory review. It is impossible to predict whether legislative changes will be enacted, or whether FDA or foreign regulations,
guidance or interpretations will be changed, or what the impact of such changes, if any, may be.

Any
delay or failure in obtaining required approvals could have a material adverse effect on our ability to generate revenues from the particular
product candidate for which we are seeking approval. Furthermore, any regulatory approval to market a product may be subject to limitations
on the approved uses for which we may market the product or the labeling or other restrictions. In addition, the FDA has the authority
to require a Risk Evaluation and Mitigation Strategy (REMS) plan as part of an NDA or biologics license application (BLA) or after approval,
which may impose further requirements or restrictions on the distribution or use of an approved drug or biologic, such as limiting prescribing
to certain physicians or medical centers that have undergone specialized training, limiting treatment to patients who meet certain safe-use
criteria and requiring treated patients to enroll in a registry. These limitations and restrictions may limit the