Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 122

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 122
---
 still submitting original
clinical or preclinical data required to support the proposed changes—such as a new formulation, dosage form, or indication. The
505(b)(2) pathway is particularly valuable for product candidates involving reformulation or repositioning of existing drugs, as it can
reduce development time and cost while maintaining rigorous regulatory review. In addition to the FDCA, pharmaceutical products are subject
to various other federal, state, and local laws and regulations.

Our product candidates are in early stages
of development and have not yet been approved for marketing or commercial distribution in the United States.

To obtain FDA approval to market and distribute
a new pharmaceutical product in the United States, a sponsor must successfully complete the following regulatory steps:

| ● | Preclinical                                                                              
 Testing: Conduct laboratory and animal studies to evaluate pharmacology, toxicology, and 
 formulation, in accordance with the FDA’s Good Laboratory Practice (GLP) regulations,    
 where applicable.                                                                        |

| ● | Manufacturing                                                                                    
 Compliance: Develop and manufacture the drug substance and drug product in accordance with       
 current Good Manufacturing Practice (cGMP) requirements, including analytical method validation, 
 process validation, and stability testing.                                                       |

| ● | Investigational                                                                          
 New Drug (IND) Application: Submit an IND to the FDA to obtain authorization to initiate 
 human clinical trials. The IND must include preclinical data, manufacturing information, 
 and a proposed clinical trial protocol. The IND must become effective (30-day FDA review 
 period) before human studies may commence.                                               |

| ● | Institutional                                                                                
 Review Board (IRB) Approval: Obtain approval from an IRB for each clinical trial site before 
 enrolling participants in any clinical study.                                                |

| ● | Clinical                                                                                       
 Trials: Conduct a series of well-controlled human clinical trials, in accordance with current  
 Good Clinical Practice (cGCP) standards, to demonstrate the safety and efficacy of the product 
 for each intended indication.                                                                  |

| ● | New                                                                                            
 Drug Application (NDA): Prepare and submit an NDA to the FDA, providing comprehensive data     
 from preclinical and clinical studies, detailed manufacturing and quality control information, 
 and proposed product labeling.                                                                 |

<div align='center'>75</div>

| ● | FDA                                                                                            
 Inspections: Undergo one or more inspections by the FDA of clinical trial sites, testing       
 facilities, and manufacturing sites (including third-party contractors), to confirm compliance 
 with cGMP, GLP, and cGCP standards, and to ensure