Company: RVRC
Filing Date: 2025-12-12
Form Type: S-1/A
Source: 0001213900-25-121070
Chunk: 130

Company: Revium Rx.
Filing Date: 2025-12-12
Form: S-1/A
Chunk 130
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 or ongoing studies, refusal to approve
pending applications, suspension or revocation of existing product licenses or approvals, issuance of warning or untitled letters, adverse
publicity, product recalls, marketing restrictions, product seizures, import detentions and refusals, total or partial suspension of
manufacturing or distribution, injunctions, fines and civil or criminal investigations and 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.