Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 24

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 24
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 development,
including involvement of senior managers and experienced review staff in a cross-disciplinary review, where appropriate.

Any
product submitted to the FDA for approval, including a product with Fast Track or Breakthrough Therapy designation, may also be
eligible for additional FDA programs intended to expedite the review and approval process, including Priority Review and Accelerated
Approval. A product is eligible for Priority Review, once an NDA is submitted, if the product that is the subject of the marketing
application has the potential to provide a significant improvement in safety or effectiveness in the treatment, diagnosis or prevention
of a serious disease or condition. Significant improvement may be illustrated by the following examples: evidence of increased
effectiveness in treatment, prevention, or diagnosis of a condition, elimination or substantial reduction of a treatment-limiting
adverse reaction, documented enhancement of patient compliance that is expected to lead to an improvement in serious outcomes,
and evidence of safety and effectiveness in a new subpopulation. Under Priority Review, the FDA’s goal date to take action
on the marketing application is six months compared to ten months for a standard review.

The
FDA may grant Accelerated Approval to a product for a serious or life-threatening condition that provides meaningful therapeutic
advantage to patients over existing treatments based upon a determination that the product has an effect on a surrogate endpoint
that is reasonably likely to predict clinical benefit. The FDA may also grant Accelerated Approval for such a condition when the
product has an effect on an intermediate clinical endpoint that can be measured earlier than an effect on irreversible morbidity
or mortality (“IMM”) and that is reasonably likely to predict an effect on irreversible morbidity or mortality or
other clinical benefit, taking into account the severity, rarity or prevalence of the condition and the availability or lack of
alternative treatments. Products granted accelerated approval must meet the same statutory standards for safety and effectiveness
as those granted traditional approval.

For
the purposes of Accelerated Approval, a surrogate endpoint is a marker, such as a laboratory measurement, radiographic image,
physical sign or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit. Surrogate
endpoints can often be measured more easily or more rapidly than clinical endpoints. An intermediate clinical endpoint is a measurement
of a therapeutic effect that is considered reasonably likely to predict the clinical benefit of a drug, such as an effect on IMM.
The FDA has limited experience with accelerated approvals based on intermediate clinical endpoints but has indicated that such
endpoints generally may support Accelerated Approval where