Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 125

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 125
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 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, 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