Company: RVRC
Filing Date: 2025-12-12
Form Type: S-1/A
Source: 0001213900-25-121070
Chunk: 158

Company: Revium Rx.
Filing Date: 2025-12-12
Form: S-1/A
Chunk 158
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)(2) pathway may be
appropriate, subject to FDA discretion, as it could allow the sponsor to reference existing safety and efficacy data on mupirocin from
prior approvals and published literature, while requiring new data to bridge the change in formulation, route of administration, and
indication. The 505(b)(2) application may rely in part on existing data for the known active ingredient, mupirocin, from the Reference
Listed Drug (Bactroban, GSK). If accepted by the FDA, this approach may enable us to leverage available data on mupirocin, including
toxicological and efficacy data from studies previously conducted by other sponsors. If permitted, this pathway could potentially offer
a more efficient and capital-sparing route to approval compared to traditional development pathways, such as 505(b)(1). While this approach
may help reduce duplicative studies, shorten timelines, and lower cost, there can be no assurance that the FDA will accept this strategy
or that it will ultimately result in approval.”

This approach has been used in other cases involving
repurposed or reformulated drugs like Liposomal Mupirocin and we believe it could be applicable for 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.

We plan to seek regulatory support mechanisms,
including Orphan Drug Designation (ODD), which may provide market exclusivity, FDA fee waivers, and potential tax credits.

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Additional designations which we may pursue include:

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

| ● | Fast Track                                                 
 Designation: Allows for early and frequent FDA engagement. |

| ● | Breakthrough                                                                                 
 Therapy Designation: Contingent on significant clinical benefit signals during early trials. |

AMR-Orphan Indication program is structured to
target diseases with low prevalence in the United States, qualifying for Orphan Drug Designation (ODD). In our assessment, we identified
several antimicrobial-resistant (AMR) indications listed in the FDA’s orphan designation database that are suitable for development
based on the known spectrum of activity of mupirocin. These include infections where MRSA, VRE, and other resistant Gram-positive pathogens
are