Company: RVRC
Filing Date: 2025-10-03
Form Type: S-1/A
Source: 0001213900-25-096094
Chunk: 134

Company: Revium Rx.
Filing Date: 2025-10-03
Form: S-1/A
Chunk 134
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 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, among other things, clinical trial design, patient informed consent,
ethical factors, the safety of human subjects and the possible liability of the institution. An IRB must operate in compliance with FDA
regulations.

The FDA, IRB or the trial sponsor may suspend
a clinical trial at any time on various grounds, including a finding that the trial is not being conducted in accordance with GCPs or
IRB requirements or that research subjects or patients are being exposed to an unacceptable health risk. In addition, some clinical trials
are overseen by an independent group of qualified experts organized by the sponsor, known as a data safety monitoring board or data monitoring
committee. Depending on its charter, this group may recommend continuation of the trial as planned, changes in trial conduct, or cessation
of the trial at designated check points based on certain available data from the trial.

A sponsor who wishes to conduct a clinical trial
outside the United States may, but need not, obtain FDA authorization to conduct the clinical trial under an IND. When a foreign clinical
trial is conducted under an IND, all FDA IND requirements must be met unless waived. When a foreign clinical trial is not conducted under
an IND, FDA may accept the results of the study in support of a BLA if the study was well-designed and conducted in accordance with GCPs,
and the FDA is able to validate the data through an onsite inspection if deemed necessary.

Clinical trials typically are conducted in three
sequential phases, but the phases may overlap or be combined. Additional studies may be required after approval.

| ● | Phase 1 clinical trials are initially conducted in a limited population of healthy subjects to test the product candidate for safety,