Company: RVRC
Filing Date: 2025-12-12
Form Type: S-1/A
Source: 0001213900-25-121070
Chunk: 132

Company: Revium Rx.
Filing Date: 2025-12-12
Form: S-1/A
Chunk 132
---
CPs,
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, 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