Company: RVRC
Filing Date: 2025-10-03
Form Type: S-1/A
Source: 0001213900-25-096094
Chunk: 161

Company: Revium Rx.
Filing Date: 2025-10-03
Form: S-1/A
Chunk 161
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 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 involved, and where liposomal delivery offers added benefit.

Focusing on these AMR-related orphan indications
supports a targeted clinical development plan with high unmet medical need, smaller trial sizes, and a strong alignment with public health
priorities. This also enhances the potential to access key regulatory incentives and pathways dedicated to antimicrobial resistance.

Expedited Regulatory Pathways and Potential Designations

We intend to evaluate and, where appropriate,
pursue various expedited development and review pathways provided by the U.S. Food and Drug Administration (FDA), including Orphan Drug
Designation (ODD), Breakthrough Therapy designation (BTD), Fast Track designation, and Priority Review, for certain of our product candidates
such as Nano-Mupirocin, Nano-Candesartan (as an ARB cancer therapy adjuvant), and our liposomal vaccine platform. These