Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 42

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 42
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20/EC. Conduct of all clinical trials performed in the European Union will continue to be bound by the Clinical Trials Directive
and the member states’ national implementing legislation until the new Clinical Trials Regulation becomes applicable. The
extent to which ongoing clinical trials will be governed by the Clinical Trials Regulation will depend on when the Clinical Trials
Regulation becomes applicable and on the duration of the individual clinical trial. If a clinical trial continues for more than
three years from the day on which the Clinical Trials Regulation becomes applicable the Clinical Trials Regulation will at that
time begin to apply to the clinical trial. The new Clinical Trials Regulation aims to simplify and streamline the approval of
clinical trials in the European Union. The main characteristics of the regulation include: a streamlined application procedure
via a single-entry point, the “European Union portal”; a single set of documents to be prepared and submitted for
the application as well as simplified reporting procedures for clinical trial sponsors; and a harmonized procedure for the assessment
of applications for clinical trials, which is divided in two parts. Part I is assessed by the competent authorities of all European
Union member states in which an application for authorization of a clinical trial has been submitted (member states concerned).
Part II is assessed separately by each member state concerned. Strict deadlines have been established for the assessment of clinical
trial applications. The role of the relevant ethics committees in the assessment procedure will continue to be governed by the
national law of the concerned European Union member state. However, overall related timelines will be defined by the Clinical
Trials Regulation.

Outside
the United States, ensuring coverage and adequate payment for a product also involves challenges. Pricing of prescription pharmaceuticals
is subject to government control in many countries. Pricing negotiations with government authorities can extend well beyond the
receipt of regulatory approval for a product and may require a clinical trial that compares the cost-effectiveness of a product
to other available therapies. The conduct of such a clinical trial could be expensive and result in delays in commercialization.
For example, in the European Union, pricing and reimbursement schemes vary widely from country to country. Some countries provide
that products may be marketed only after a reimbursement price has been agreed upon. Some countries may require the completion
of additional studies that compare the cost-effectiveness of a particular compound to currently available therapies or so-called
health technology assessments, in order to obtain reimbursement or pricing approval. For example, the European Union provides
options for its member states to restrict the range of products for which their national health insurance systems provide reimbursement