Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 17

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 17
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 sometimes referred to as phase 4 clinical trials or post-marketing studies, may be conducted after initial marketing approval.
These trials are used to gain additional evidence from the treatment of study subjects in the intended therapeutic indication
and are commonly intended to generate additional safety data regarding use of the product in a clinical setting, or in some cases
to confirm clinical benefit. In certain instances, the FDA may mandate the performance of phase 4 clinical trials as a condition
of NDA approval.

10 

Progress
reports detailing the results of the clinical trials, among other information, must be submitted at least annually to the FDA.
Written IND safety reports must be submitted to the FDA and the investigators fifteen days after the trial sponsor determines
the information qualifies for reporting for serious and unexpected suspected adverse events, findings from other studies or animal
or in vitro testing that suggest a significant risk for human volunteers, and any clinically important increase in the rate of
a serious suspected adverse reaction over that listed in the protocol or investigator brochure. The sponsor must also notify the
FDA of any unexpected fatal or life-threatening suspected adverse reaction as soon as possible but in no case later than seven
calendar days after the sponsor’s initial receipt of the information.

Concurrent
with clinical trials, companies usually complete additional animal studies and must also develop additional information about
the chemistry and physical characteristics of the compound and finalize a process for manufacturing the drug product in commercial
quantities in accordance with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches
of the compound and manufacturers must develop, among other things, methods for testing the identity, strength, quality and purity
of the final drug product. Additionally, appropriate packaging must be selected and tested, and stability studies must be conducted
to demonstrate that the compound does not undergo unacceptable deterioration over its shelf life.

Expanded
Access

Expanded
access, sometimes called “compassionate use,” is the use of investigational products outside of controlled clinical
trials to treat patients with serious or immediately life-threatening diseases or conditions when there are no comparable or satisfactory
alternative treatment options. FDA regulations allow access to investigational products under an IND by the sponsor or the treating
physician for treatment purposes on a case-by-case basis for the following groups: individual patients (single-patient IND applications
for treatment in emergency settings and non-emergency settings); intermediate-size patient populations; and larger populations
for use of the investigational product under a treatment protocol or treatment IND.

A
clinical trial sponsor is not obligated under the