Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 151

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 151
---
 and antimicrobial activity against serious and resistant bacterial pathogens identified by the CDC.

The 505(b)(2) pathway is well-suited for this
product, as it allows us to bridge existing data on both the active ingredient (mupirocin) and the well-characterized and FDA-approved
liposomal delivery platform, while generating new data specific to the systemic application of the formulation. This regulatory strategy
provides a scientifically sound and capital-efficient path to approval, facilitating accelerated development of a critical new therapeutic
in the context of the growing global threat of antimicrobial resistance.

The 505(b)(2) pathway is appropriate because
it allows the sponsor to reference existing safety and efficacy data on mupirocin from prior approvals and published literature, while
only requiring new data to bridge the change in formulation, route of administration, and indication. The 505 (b) (2) application relies
partially on the existing data for the known active ingredient, mupirocin, from the Reference Listed Drug (Bactroban, GSK). By referring
to the approved reference listed drug, we will be able to utilize available data on mupirocin, including toxicological and efficacy data
from studies previously conducted by other sponsors. This approach offers a significantly faster and less expensive route to approval
compared to traditional development pathways, such as 505(b)(1).This streamlines development by reducing the need for duplicative studies,
shortening timelines, and lowering cost—while maintaining rigorous FDA review standards.

This approach is well-suited for repurposed
or reformulated drugs like Liposomal Mupirocin and has been successfully used in similar cases involving nanoparticle, liposomal, or
IV versions of previously approved compounds.

Given the public health priority of antibiotic
resistance, we may seek QIDP designation (Qualified Infectious Disease Product) and Fast Track status, which provide priority review
and extended exclusivity.

Regulatory support mechanisms will be leveraged,
including Orphan Drug Designation (ODD), which grants market exclusivity, FDA fee waivers, and potential tax credits. The program may
also qualify for the Rare Pediatric Disease Priority Review Voucher (RPD PRV), offering a transferable incentive valued up to several
hundred million dollars.

<div align='center'>91</div>

Additional designations to be pursued include:

I. Qualified Infectious Disease Product (QIDP):
Grants an extra 5 years of exclusivity.

| ● | Fast Track