Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 124

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 124
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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 the disease or condition to be treated under the supervision
of qualified investigators. Clinical trials must be conducted in accordance with GCPs, which establish ethical and data integrity standards
for clinical testing, as well as the requirements for informed consent.

Clinical trials are conducted under protocols
detailing, among other things, the objectives of the trial, dosing procedures, inclusion and exclusion criteria, the parameters to be
used in monitoring safety, and the effectiveness criteria to be evaluated. A protocol for each clinical trial and any subsequent protocol
amendments must be submitted to the FDA as part of the IND.

For clinical trials conducted in the United
States, an IND is required, and each clinical trial must be reviewed and approved by an IRB either centrally or individually at each
institution at which the clinical trial will be conducted. The IRB will consider,