Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 126

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 126
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 dosage regimens, generate substantial 
 evidence of clinical efficacy, and expand the safety database by evaluating the investigational   
 product in a broader and more diverse patient population across multiple, geographically          
 dispersed clinical trial sites. These trials are generally well-controlled and statistically      
 powered to support regulatory decision-making regarding product approval and labeling.            |

Such studies are commonly referred
to as “pivotal trials,” as they are designed to provide the definitive data required by regulatory authorities to assess
the risk-benefit profile of the product. However, in certain cases, such as for investigational products targeting rare diseases with
Orphan Drug Designation, a Phase 2 trial may be deemed pivotal if it is sufficiently robust to provide the clinical evidence necessary
to support targeted marketing application.

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While the IND is active and before approval,
progress reports detailing the results of the clinical trials and preclinical studies performed since the last progress report must be
submitted at least annually to the FDA and written IND safety reports must be submitted to the FDA and the investigators for serious
and unexpected suspected adverse events, findings from other studies or animal or in vitro testing that suggest a significant
risk for human subjects and any clinically important increase in the rate of a serious suspected adverse reaction over that listed in
the protocol or investigator brochure. The sponsor must submit an IND safety report within 15 calendar days after the sponsor determines
that the information qualifies for reporting. The sponsor also must notify the FDA of any unexpected fatal or life-threatening suspected
adverse reaction within seven calendar days after the sponsor’s initial receipt of the information.

There are also requirements governing the
reporting of ongoing clinical trials and clinical trial results to public registries. Sponsors of certain clinical trials of FDA-regulated
products are required to register and disclose information about ongoing clinical trials, including information related to the drug,
patient population, phase of investigation, trial sites and investigators. Sponsors are also obligated to disclose theresults
of completed clinical trials, other than Phase 1 clinical trials, within specific timeframes. Information about applicable clinical
trials is published on www.ClinicalTrials.gov, a clinical trials database maintained by the National Institute of Health (NIH).

During the development of a new pharmaceutical
product, sponsors are given opportunities to meet with the FDA at certain points. These points may be prior to submission of an IND,
at the end of Phase 2, and before an NDA is submitted. Meetings at other times may be requested.