Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 21

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 21
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, including the advisory committee recommendation, if any, and inspection reports
regarding the manufacturing facilities and clinical trial sites, the FDA may issue an approval letter, or, in some cases, a complete
response letter. A complete response letter indicates that the review cycle of the application is complete, and the application
is not ready for approval. A complete response letter generally contains a statement of specific conditions that must be met in
order to secure final approval of the NDA, except that where the FDA determines that the data supporting the application are inadequate
to support approval, the FDA may issue the complete response letter without first conducting required inspections, testing submitted
product lots, and/or reviewing proposed labeling. In issuing the complete response letter, the FDA may require additional clinical
or preclinical testing or recommend other actions, such as requests for additional information or clarification, that the applicant
might take in order for the FDA to reconsider the application. Even with submission of this additional information, the FDA ultimately
may decide that the application does not satisfy the regulatory criteria for approval. If and when those conditions have been
met to the FDA’s satisfaction, the FDA will typically issue an approval letter. An approval letter authorizes commercial
marketing of the product with specific prescribing information for specific indication(s).

Even
if the FDA approves a product, depending on the specific risk(s) to be addressed it may limit the approved indications for use
of the product, require that contraindications, warnings or precautions be included in the product labeling, require that post-approval
studies, including phase 4 clinical trials, be conducted to further assess a product’s maximum tolerable dose and efficacy
after approval, require testing and surveillance programs to monitor the product after commercialization, or impose other conditions,
including distribution and use restrictions or other risk management mechanisms under a REMS, which can materially affect the
potential market and profitability of the product. The FDA may prevent or limit further marketing of a product based on the results
of post-marketing studies or surveillance programs. After approval, some types of changes to the approved product, such as adding
new indications, manufacturing changes, and additional labeling claims, are subject to further testing requirements and FDA review
and approval.

Orphan
Drug Designation and Exclusivity

Under
the Orphan Drug Act, the FDA may grant orphan drug designation to a drug intended to treat a rare disease or condition, which
is a disease or condition with either a patient population of fewer than 200,000 individuals