Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 254

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 254
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 these are not the only regulatory regimes to which we may be subject in the event we are able to execute
on our objectives.

These
regulatory review committees and advisory groups and the new guidelines they promulgate may lengthen the regulatory review process,
require us to perform additional studies, increase our development costs, lead to changes in regulatory positions and interpretations,
delay or prevent approval and commercialization of CC8464, CT2000 and CT3000 or future compounds or lead to significant post-approval
limitations or restrictions. As we advance CC8464, CT2000 and CT3000, we will be required to consult with these regulatory and
advisory groups and comply with applicable guidelines. If we fail to do so, we may be required to delay or discontinue development
of CC8464, CT2000 and CT3000. These additional processes may result in a review and approval process that is longer than we otherwise
would have expected. Delay or failure to obtain, or unexpected costs in obtaining, the regulatory approval necessary to bring
a potential product to market could decrease our ability to generate sufficient product revenue, and our business, financial condition,
results of operations and prospects would be materially and adversely affected.

38 

Even
if we obtain regulatory approval for CC8464, CT2000 and CT3000, our compounds will remain subject to regulatory oversight.

Even
if we obtain any regulatory approval for CC8464, CT2000 and CT3000, our lead compounds, they will be subject to ongoing regulatory
requirements for manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping and submission
of safety and other post-market information. Any regulatory approvals that we receive for CC8464, CT2000 and CT3000 may also be
subject to a post-approval safety monitoring program, limitations on the approved indicated uses for which the product may be
marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including Phase
4 clinical trials, and surveillance to monitor the quality, safety and efficacy of the product. For example, the holder of an
approved NDA is obligated to monitor and report adverse events and any failure of a product to meet the specifications in the
NDA. The holder of an approved NDA also must submit new or supplemental applications and obtain FDA approval for certain changes
to the approved product, product labeling or manufacturing process. Advertising and promotional materials must comply with FDA
rules and are subject to FDA