Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 20

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 20
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 NDA and respond to the applicant, and six months from
the filing date of a new molecular entity NDA for priority review. The FDA does not always meet its PDUFA goal dates for standard
or priority NDAs, and the review process is often extended by FDA requests for additional information or clarification.

Further,
under PDUFA, each NDA must be accompanied by a substantial user fee. For fiscal year 2025, the application fee for each application
containing clinical data is $4,310.002. PDUFA also imposes an annual program fee for each approved prescription drug, which has
been set at $403,889 for fiscal year 2025. The FDA adjusts the PDUFA user fees on an annual basis. Fee waivers or reductions are
available in certain circumstances, including a waiver of the application fee for the first application filed by a small business.
Additionally, no user fees are assessed on applications for products designated as orphan drugs, unless the product also includes
a non-orphan indication.

The
FDA also may require submission of a Risk Evaluation and Mitigation Strategy (“REMS”) if it believes that a risk evaluation
and mitigation strategy is necessary to ensure that the benefits of the drug outweigh its risks. A REMS can include use of risk
evaluation and mitigation strategies like medication guides, physician communication plans, assessment plans, and/or elements
to assure safe use such as restricted distribution methods, patient registries, special monitoring or other risk-minimization
tools.

The
FDA may refer an application for a novel drug to an advisory committee. An advisory committee is a panel of independent experts,
including clinicians and other scientific experts, which reviews, evaluates and provides advice and recommendations to FDA as
to whether the application should be approved and under what conditions. The FDA is not bound by the recommendations of an advisory
committee, but it considers such recommendations carefully when making decisions.

Before
approving an NDA, the FDA typically will inspect the facility or facilities where the product is manufactured. The FDA will not
approve an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements
and are adequate to assure consistent production of the product within required specifications. Additionally, before approving
an NDA, the FDA may inspect one or more select clinical trial sites involved in conducting pivotal studies to assure compliance
with GCP and other requirements and the integrity of the clinical data submitted to the FDA.

12 

After
evaluating the NDA and all related information