Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 15

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 15
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 the product; chemistry, manufacturing, and
controls information; and any available human data or literature to support the use of the investigational product. Some long-term
preclinical testing may continue after the IND is submitted. The IND automatically becomes effective 30 days after receipt by
the FDA, unless the FDA, within the 30-day time period, raises concerns or questions about the conduct of the proposed clinical
trial, including concerns that human research subjects will be exposed to unreasonable health risks, refuses to allow the IND
to take effect until the FDA’s concerns and questions have been addressed and/or imposes a full or partial clinical hold.
The FDA must notify the sponsor of the grounds for the hold, and any identified deficiencies must be resolved before the clinical
trial can begin. Submission of an IND may result in the FDA not allowing clinical trials to commence or not allowing clinical
trials to commence on the terms originally specified in the IND. A clinical hold can also be imposed once a trial has already
begun, thereby halting the trial until the deficiencies articulated by FDA are corrected.

9 

The
clinical stage of development involves the administration of the compounds to healthy volunteers or patients under the supervision
of qualified investigators, who generally are physicians not employed by or under the trial sponsor’s control, in accordance
with GCP requirements, which include the requirements that all research subjects provide their informed consent for their participation
in any clinical trial. Clinical trials are conducted under protocols detailing, among other things, the objectives of the clinical
trial, dosing procedures, subject selection and exclusion criteria, and the parameters and criteria to be used in monitoring safety
and evaluating effectiveness. Each protocol, and any subsequent amendments to the protocol, must be submitted to the FDA as part
of the IND.

Furthermore,
each clinical trial must be reviewed and approved by an IRB or IEC for each institution at which the clinical trial will be conducted
to ensure that the risks to individuals participating in the clinical trials are minimized and are reasonable compared to the
anticipated benefits. The IRB or IEC also approves the informed consent form that must be provided to each clinical trial subject
or his or her legal representative and must monitor the clinical trial until completed. The FDA, the IRB or IEC, or the sponsor
may suspend or discontinue a clinical trial at any time on various grounds, including a finding that the subjects are being exposed
to an unacceptable health risk. There also are requirements governing the reporting of ongoing clinical trials and completed clinical
tr