Company: RVRC
Filing Date: 2025-10-03
Form Type: S-1/A
Source: 0001213900-25-096094
Chunk: 135

Company: Revium Rx.
Filing Date: 2025-10-03
Form: S-1/A
Chunk 135
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 including adverse effects, dose tolerance, absorption, metabolism, distribution, excretion and PD. In the case of some products designed to address severe or life-threatening diseases, initial human testing is often conducted in patients with the disease, especially when the product may be too inherently toxic to ethically administer to healthy volunteers. |

| ● | Phase 2 clinical trials are generally conducted in a limited patient population to identify possible adverse effects and safety risks, evaluate the preliminary efficacy of the product candidate for specific targeted indications and determine dose tolerance and recommended dosage. Multiple Phase 2 clinical trials may be conducted by the sponsor to obtain information prior to beginning larger and more costly Phase 3 clinical trials. |

| ● | Phase 3 clinical trials are typically conducted to further refine 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