Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 16

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 16
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ials to public registries. Information about clinical trials, including results for clinical trials other than phase 1 investigations,
must be submitted within specific timeframes for publication on www.ClinicalTrials.gov, a clinical trials database maintained
by the National Institutes of Health.

A
sponsor who wishes to conduct a clinical trial outside of the United States are subject to the requirements of the applicable
jurisdiction and may, but need not, obtain FDA authorization to conduct the clinical trial under an IND. If a foreign clinical
trial is not conducted under an IND, the FDA will nevertheless accept the results of the study in support of an NDA if the study
was conducted in accordance with GCP requirements, and the FDA is able to validate the data through an onsite inspection if deemed
necessary.

Clinical
trials to evaluate therapeutic indications to support NDAs for marketing approval are typically conducted in three sequential
phases, which may overlap.

    ●
    Phase 1 —
    Phase 1 clinical trials involve initial introduction of the investigational product in a limited population of healthy human
    volunteers or patients with the target disease or condition. These studies are typically designed to test the safety, dosage
    tolerance, absorption, metabolism and distribution of the investigational product in humans, evaluate the side effects associated
    with increasing doses, and, if possible, to gain early evidence of effectiveness.

    ●
    Phase 2 —
    Phase 2 clinical trials typically involve administration of the investigational product to a limited patient population with
    a specified disease or condition to evaluate the drug’s potential efficacy, to determine the optimal dosages and dosing
    schedule, and to identify possible adverse side effects and safety risks.

    ●
    Phase 3 —
    Phase 3 clinical trials typically involve administration of the investigational product to an expanded patient population
    to further evaluate dosage, to provide statistically significant evidence of clinical efficacy, and to further test for safety,
    generally at multiple geographically dispersed clinical trial sites. These clinical trials are intended, with the other available
    evidence, to establish the overall risk/benefit ratio of the investigational product and to provide an adequate basis for
    product approval and physician labeling. Generally, two adequate and well-controlled phase 3 trials are required by the FDA
    for approval of an NDA. Under certain circumstances, FDA can conclude that one adequate and well-controlled clinical investigation
    plus confirmatory evidence is sufficient to establish effectiveness.

Post-approval
trials,