Company: RVRC
Filing Date: 2025-02-14
Form Type: S-1
Source: 0001213900-25-013823
Chunk: 85

Company: Revium Rx.
Filing Date: 2025-02-14
Form: S-1
Chunk 85
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 tests and protocols for clinical tests, which must become effective before clinical trials      
 may begin in the United States;                                                                 |

| ● | obtaining                                                                                        
 approval of Institutional Review Boards to administer the products to human subjects in clinical 
 trials;                                                                                          |

| ● | adequate                                                                                      
 and well-controlled human clinical trials to establish the safety and efficacy of the product 
 for the product’s intended use;                                                               |

| ● | development                                                                              
 of manufacturing processes which conform to FDA current Good Manufacturing Practices, or 
 cGMPs, as confirmed by FDA inspection;                                                   |

| ● | submission                                                                                   
 of preclinical and clinical test results, and chemistry, manufacture and control information 
 on the product to the FDA in a New Drug Approval Application, or NDA; and                    |

| ● | FDA                                                                                   
 review and approval of an NDA, prior to any commercial sale or shipment of a product. |

The testing and approval process requires substantial time, effort, and financial resources. The results of the preclinical tests, together with initial specified manufacturing information, the proposed clinical trial protocol, and information about the participating investigators, are submitted to the FDA as part of an IND, which must be approved before we may begin human clinical trials. Additionally, an independent Institutional Review Board at each clinical trial site proposing to conduct the clinical trials must review and approve each study protocol and oversee conduct of the trial. An IND becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day period, raises concerns or questions about the conduct of the trials as outlined in the IND and imposes a clinical hold. If the FDA imposes a clinical hold, the IND sponsor must resolve the FDA’s concerns before clinical trials can begin. Pre-clinical tests and studies can take several years to complete, and there is no guarantee that an IND we submit based on such tests and studies will become effective within any specific time period, if at all.

Human clinical trials are typically conducted in three sequential phases that may overlap:

| ● | Phase                                                                                      
 I: The drug is initially introduced into healthy human subjects or patients and tested for 
 safety and dosage tolerance. Absorption, metabolism, distribution, and excretion testing   
 is generally performed at this stage.                                                      |

| ● | Phase                                                                                             
 II: The drug is studied in controlled, exploratory therapeutic trials in a limited number         
 of subjects with the disease or medical condition for which the new drug is intended to be        
 used in order to identify possible adverse effects and safety risks, to determine the