Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 23

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 23
---
 of the product to meet the needs of patients with the rare disease
or condition, or if the manufacturer chooses to provide consent to approval of other applications.

13 

Expedited
Development and Review Programs for Drugs

The
FDA maintains several programs intended to facilitate and expedite development and review of new drugs to address unmet medical
needs in the treatment of serious or life-threatening diseases or conditions. These programs include Fast Track designation, Breakthrough
Therapy designation, Priority Review and Accelerated Approval, and the purpose of these programs is to either expedite the development
or review of important new drugs and biologics to get them to patients more quickly than standard FDA review timelines typically
permit. We intend to apply for these programs for compounds, as applicable.

A
new drug is eligible for Fast Track designation if it is intended to treat a serious or life-threatening disease or condition
and demonstrates the potential to address unmet medical needs for such disease or condition. Fast Track designation applies to
the compound and the specific indication for which it is being studied. The sponsor of a new drug product may request the FDA
to designate the drug as a Fast Track product at any time during the clinical development of the product, but ideally no later
than the pre-NDA meeting because many of the features of Fast Track designation will not apply after that time. Fast Track designation
provides increased opportunities for sponsor interactions with the FDA during preclinical and clinical development, in addition
to the potential for rolling review once a marketing application is filed. Rolling review means that the FDA may review portions
of the marketing application before the sponsor submits the complete application.

In
addition, a new drug may be eligible for Breakthrough Therapy designation if it is intended to treat a serious or life-threatening
disease or condition and preliminary clinical evidence indicates that the drug, alone or in combination with one or more other
drugs, may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as
substantial treatment effects observed early in clinical development. A sponsor may request that a drug product be designated
as a Breakthrough Therapy at any time during the clinical development of the product and ideally before initiation of the pivotal
clinical trial intended to serve as the primary basis for demonstration of efficacy to obtain the full benefits of the designation.
Breakthrough Therapy designation provides all the features of Fast Track designation, in addition to intensive guidance on an
efficient product development program beginning as early as phase 1 and FDA organizational commitment to expedited