Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 26

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 26
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 Approval do not change the scientific or medical standards for approval or
the quality of evidence necessary to support approval, though they may expedite the development or review process.

Pediatric
Study Plan and Pediatric Exclusivity

Under
the Pediatric Research Equity Act, as amended (the “PREA”), certain NDAs and certain NDA supplements must contain
data that can be used to assess the safety and efficacy of the compound for the claimed indications in all relevant pediatric
subpopulations and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective.
For a cancer drug directed at a molecular target, the pediatric testing requirement extends to pediatric cancers involving the
molecular target even if different than the claimed adult cancer in the NDA. The FDA may grant deferrals for submission of pediatric
data or full or partial waivers. The PREA requires that a sponsor who is planning to submit a marketing application for a compound
that includes a new active ingredient, new indication, new dosage form, new dosing regimen or new route of administration submit
an initial Pediatric Study Plan (the “PSP”), within 60 days of an end-of-phase 2 meeting or, if there is no such meeting,
as early as practicable before the initiation of the phase 3 or phase 2/3 study. The initial PSP must include an outline of the
pediatric study or studies that the sponsor plans to conduct, including study objectives and design, age groups, relevant endpoints
and statistical approach, or a justification for not including such detailed information, and any request for a deferral of pediatric
assessments or a full or partial waiver of the requirement to provide data from pediatric studies along with supporting information.
The FDA and the sponsor must reach an agreement on the PSP. A sponsor can submit amendments to an agreed-upon initial PSP at any
time if changes to the pediatric plan need to be considered based on data collected from preclinical studies, early phase clinical
trials and/or other clinical development programs. Unless otherwise required by regulation, the PREA does not apply to a drug
for an indication for which orphan drug designation has been granted, except that the PREA will apply to an original NDA for a
new active ingredient that is orphan-designated if the drug is a molecularly targeted cancer product intended for the treatment
of an adult cancer and is directed at a molecular target that the FDA determines to be substantially relevant to the growth or
progression of a pediatric cancer.

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