Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 13

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 13
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 compounds, as small molecule drugs, would
be regulated as new drugs rather than biologics. The FDA regulates new drug products under the Federal Food, Drug, and Cosmetic
Act, as amended (the “FDCA”) and its implementing regulations. New drug products are also subject to other federal,
state and local statutes and regulations. If we fail to comply with applicable FDA or other requirements at any time with respect
to product development, clinical testing, approval or any other regulatory requirements relating to product manufacture, processing,
handling, storage, quality control, safety, marketing, advertising, promotion, packaging, labeling, export, import, distribution,
or sale, we may become subject to administrative or judicial sanctions or other legal consequences. These sanctions or consequences
could include, among other things, the FDA’s refusal to approve pending applications, issuance of clinical holds for proposed
or ongoing studies, suspension or revocation of approvals, warning or untitled letters, product withdrawals or recalls, product
seizures, relabeling or repackaging, total or partial suspensions of manufacturing or distribution, injunctions, fines, civil
penalties or criminal prosecution.

Compounds
must be approved for therapeutic indications by the FDA before they may be marketed in the United States. For new drug products
regulated under the FDCA, a sponsor must submit a U.S. New Drug Application (“NDA”) to the FDA for review and approval.
The NDA review and approval process may take multiple years and involves the following steps:

    ●
    completion of extensive
    preclinical studies in accordance with applicable regulations, including studies conducted in accordance with Good Laboratory
    Practice (“GLP”) requirements;

8 

    ●
    completion of the
    manufacture, under current Good Manufacturing Practices (“cGMP”) conditions of the drug substance, drug product,
    and labeling and packaging that the sponsor intends to use in human clinical trials along with required analytical and stability
    testing;

    ●
    submission to the
    FDA of an Investigational New Drug Application (“IND”), which must become effective before clinical trials may
    begin and must be updated annually and amended when certain changes are made;

    ●
    approval by an institutional
    review board (“IRB”) or independent ethics committee (“IEC”) at each clinical trial site before each
    trial may be initiated;

    ●
    performance of adequate
    and well-controlled clinical trials in accordance with applicable IND regulations, Good Clinical Practice (“GCP”)