Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 14

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 14
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 requirements, including informed consent, financial disclosure by investigators and other clinical trial-related regulations,
    to establish maximum tolerable dose and efficacy of the investigational product for each proposed indication and other condition
    of use;

    ●
    preparation and
    submission to the FDA of an NDA;

    ●
    a determination
    by the FDA within 60 days of its receipt of an NDA to file the application for review;

    ●
    satisfactory completion
    of one or more FDA pre-approval inspections of the manufacturing facility or facilities where the drug will be produced to
    assess compliance with cGMP requirements to assure that the facilities, methods and controls are adequate to preserve the
    drug product’s identity, strength, quality and purity;

    ●
    satisfactory completion
    of FDA inspection of select clinical trial sites involved in conducting pivotal studies that generated the data in support
    of the NDA;

    ●
    payment of user
    fees for FDA review of the NDA; and

    ●
    FDA review and approval
    of the NDA, including of the proposed prescribing information and, where applicable, consideration of the views of any FDA
    advisory committee, prior to any commercial marketing or sale of the drug in the United States.

Preclinical
Studies and Clinical Trials for Drugs

Before
testing any drug in humans, compound must undergo rigorous preclinical testing. Preclinical studies include laboratory evaluations
of product chemistry, formulation and stability, as well as in vitro and animal studies to assess maximum tolerable dose and in
some cases to establish the rationale for therapeutic use. The conduct of preclinical studies is subject to federal and state
regulation and requirements, including GLP requirements under 21 C.F.R. Part 58 and animal testing requirements under the Animal
Welfare Act Amendments of 1976 (7 U.S.C. 2131 et seq.). The results of the preclinical studies, together with manufacturing information
and analytical data, must be submitted to the FDA as part of an IND.

An
IND is a submission to the FDA under which a sponsor proposes to administer an investigational product to humans. An IND must
become effective before the proposed clinical trials may begin. The central focus of an IND submission is on the general investigational
plan and the protocol(s) for clinical studies. The IND also includes the results of animal and in vitro studies assessing the
toxicology, pharmacokinetics, pharmacology, and pharmacodynamic characteristics of