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

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 25
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 the therapeutic effect measured by the endpoint is not itself a clinical
benefit and basis for traditional approval, if there is a basis for concluding that the therapeutic effect is reasonably likely
to predict the ultimate clinical benefit of a product.

14 

The
Accelerated Approval pathway is most often used in settings in which the course of a disease is long, and an extended period of
time is required to measure the intended clinical benefit of a product, even if the effect on the surrogate or intermediate clinical
endpoint occurs rapidly. Thus, Accelerated Approval has been used extensively in the development and approval of products for
treatment of a variety of cancers in which the goal of therapy is generally to improve survival or decrease morbidity and the
duration of the typical disease course requires lengthy and sometimes large trials to demonstrate a clinical or survival benefit.
Thus, the benefit of Accelerated Approval derives from the potential to receive approval based on surrogate endpoints sooner than
possible for trials with clinical or survival endpoints, rather than deriving from any explicit shortening of the FDA approval
timeline, as is the case with priority review.

The
Accelerated Approval pathway is usually contingent on a sponsor’s agreement to conduct, in a diligent manner, additional
post-approval confirmatory studies to verify and describe the product’s clinical benefit. As a result, a compound approved
on this basis is subject to rigorous post-marketing compliance requirements, including the completion of phase 4 or post-approval
clinical trials to confirm the effect on the clinical endpoint. Failure to conduct required post-approval studies, or confirm
a clinical benefit during post-marketing studies, would allow the FDA to initiate expedited proceedings to withdraw approval of
the product. All promotional materials for compounds approved under accelerated regulations are subject to prior review by the
FDA. In addition, the FDA generally requires, as a condition for Accelerated Approval, that all advertising and promotional materials
intended for dissemination or publication within 120 days of marketing approval be submitted to the agency for review during the
pre-approval review period. After the 120-day period has passed, all advertising and promotional materials must be submitted at
least 30 days prior to the intended time of initial dissemination or publication.

Even
if a product qualifies for one or more of these programs, the FDA may later decide that the product no longer meets the conditions
for qualification or the time period for FDA review or approval may not be shortened. Furthermore, Fast Track designation, Breakthrough
Therapy designation, Priority Review and Accelerated