Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 153

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 153
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, these beliefs are based on our
current development plans and nonclinical data, and actual eligibility for any FDA designation is subject to further evaluation by the
FDA following submission of the relevant data.

Limitations and Regulatory Uncertainty:

While these designations can provide
potential benefits, including more frequent interactions with the FDA, eligibility for rolling submissions, and in some cases shorter
review timelines, they do not guarantee a faster development or approval process. Moreover, they do not increase the likelihood that a product candidate will ultimately receive marketing approval. Because our product candidates are in early stages of development,
there can be no assurance that the FDA will grant any such designation or accept any application under an expedited program.

Furthermore, even if one or more of our
product candidates receive such designations, the FDA may later rescind them if subsequent data fail to confirm the initial qualifying
criteria.

European Union

We intend to pursue marketing authorization
for Nano-Mupirocin via the European Medicines Agency (EMA) under the centralized procedure, which ensures access across all EU member
states and is required for novel antimicrobial therapies. Nano-Mupirocin, a novel liposomal formulation of mupirocin for systemic (parenteral)
use, is designed to treat serious, resistant bacterial infections, addressing critical unmet needs in the context of antimicrobial resistance
(AMR).

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Given the severity and limited treatment options
for certain resistant infections, particularly those affecting vulnerable populations, we plan to seek Orphan Medicinal Product Designation
(OMPD) for relevant rare infectious disease indications. To qualify, we will demonstrate that:

| ● | The                                                                                
 target condition has a prevalence of fewer than 5 in 10,000 individuals in the EU; |

| ● | Nano-Mupirocin                                                                            
 offers significant benefit over existing therapies, such as improved systemic activity or 
 a novel mechanism of action;                                                              |

| ● | There                                                                                   
 is a plausible scientific rationale for its clinical effect in the proposed indication. |

| ● | Upon                                          
 OMPD approval, the product will benefit from: |

| ● | 10                                                    
 years of market exclusivity in the orphan indication; |

| ● | Protocol                                             
 assistance (free or reduced-cost scientific advice); |

| ● | Fee                                           
 reductions for various regulatory activities. |

As part of our development strategy, we will
also submit a Pediatric Investigation Plan (PIP), as required under EU regulation for all new marketing authorization applications, including