Company: RVRC
Filing Date: 2025-10-03
Form Type: S-1/A
Source: 0001213900-25-096094
Chunk: 133

Company: Revium Rx.
Filing Date: 2025-10-03
Form: S-1/A
Chunk 133
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 penalties brought by the FDA or the Department of Justice
(“DOJ”), and other governmental entities, including state agencies.

Preclinical Studies and Investigational New Drug Application

Once a therapeutic product candidate is identified
for development, it must undergo preclinical studies (also known as preclinical testing) before any testing may be conducted in humans.
Preclinical tests include laboratory evaluations of product chemistry, formulation and stability, as well as studies to evaluate the potential
for efficacy and toxicity in animals. The conduct of preclinical tests and formulation of the compounds for testing must comply with federal
regulations and requirements, including GLPs. The results of the preclinical tests, together with manufacturing information, analytical
data, and plans for the proposed clinical studies, are submitted to the FDA as part of an IND. Some preclinical testing may continue after
an IND is submitted.

An IND is a request for FDA authorization to administer
an investigational new drug product to humans. The IND automatically becomes effective 30 days after receipt by the FDA, unless before
that time the FDA raises concerns or questions about the product or the conduct of the proposed clinical trial, including concerns that
human research subjects will be exposed to unreasonable health risks. In that case, the IND sponsor and the FDA must resolve any outstanding
FDA concerns before the clinical trials can begin. As a result, submission of an IND may or may not result in FDA authorization to begin
a clinical trial, or to begin a clinical trial on the terms originally specified by the sponsor in the IND.

At any time during the initial 30-day IND review
period or while clinical trials are ongoing under the IND, the FDA may impose a partial or complete clinical hold. Clinical holds may
be imposed by the FDA when there is concern for patient safety, and may be a result of new data, findings, or developments in clinical,
preclinical, and/or chemistry, CMC or where there is non-compliance with regulatory requirements. This order would delay either a proposed
clinical trial or cause suspension of an ongoing trial, until all outstanding concerns have been adequately addressed and the FDA has
notified the company that investigations may proceed. A separate submission to an existing IND must also be made for each successive clinical
trial conducted, and the FDA must grant permission, either explicitly or implicitly, by not objecting before each clinical trial can begin.

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Human Clinical Trials

Clinical trials involve the administration of
an investigational drug product to healthy volunteers or patients with