Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 19

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 19
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 individual patient, but the sponsor must develop a policy and respond to patient requests according to that policy.

11 

U.S.
Marketing Approval for Drugs

Assuming
successful completion of the required clinical testing, the results of the preclinical studies and clinical trials, together with
detailed information relating to the product’s chemistry, manufacture, controls and proposed labeling, among other things,
are submitted to the FDA as part of an NDA package requesting approval to market the drug product for one or more indications.
An NDA is an application to FDA for approval to market a new drug for one or more specified indications and must contain proof
of the drug’s maximum tolerable dose and efficacy for the requested indication(s). An NDA is required to include both negative
and ambiguous results of preclinical studies and clinical trials, as well as positive findings, together with detailed information
relating to the product’s chemistry, manufacturing, controls, and proposed labeling, among other things. Data may come from
company-sponsored clinical trials intended to test the maximum tolerable dose and efficacy of a product’s use or from several
alternative sources, including studies initiated by investigators. To support marketing approval, the data submitted must be sufficient
in quality and quantity to establish the maximum tolerable dose and efficacy of the investigational drug, to the satisfaction
of the FDA. The FDA must approve an NDA before a drug may be marketed in the United States.

The
FDA reviews all submitted NDAs to ensure they are sufficiently complete to permit substantive review before it accepts them for
filing and may request additional information rather than accepting the NDA for filing. The FDA must make a decision on accepting
an NDA for filing within 60 days of receipt, and such decision could include a “refuse-to-file” decision by the FDA.
Once the submission is accepted for filing, the FDA begins an in-depth substantive review of the NDA. The FDA reviews an NDA to
determine, among other things, whether the product is safe and effective for the indications sought and whether the facility in
which it is manufactured, processed, packaged or held meets standards designed, including cGMP requirements, designed to assure
and preserve the product’s continued identity, strength, quality and purity. Under the goals and polices agreed to by the
FDA under the Prescription Drug User Fee Act, as amended (the “PDUFA”), the FDA targets ten months, from the filing
date, in which to complete its initial review of a new molecular entity