Company: RVRC
Filing Date: 2025-10-03
Form Type: S-1/A
Source: 0001213900-25-096094
Chunk: 140

Company: Revium Rx.
Filing Date: 2025-10-03
Form: S-1/A
Chunk 140
---
ations

The FDA has several programs intended to facilitate
and expedite development and review of new products that are intended to address an unmet medical need in the treatment of a serious or
life-threatening disease or condition. These programs are referred to as fast track designation, breakthrough therapy designation and
priority review designation. These designations are not mutually exclusive, and a product candidate may qualify for one or more of these
programs. While these programs are intended to expedite product development and approval, they do not alter the standards for FDA approval.

The FDA may designate a product for fast track
designation if it is intended for the treatment of a serious or life-threatening disease or condition, and preclinical or clinical data
demonstrate the potential to address unmet medical needs for such a disease or condition. For products with fast track designation, sponsors
may have more frequent interactions with the FDA, the product is potentially eligible for accelerated approval and priority review, if
relevant criteria are met. and the NDA may be eligible for “rolling review,” under which the FDA may consider sections of
the NDA for review on a rolling basis before the complete application is submitted. This rolling review may be available if the FDA determines,
after preliminary evaluation of clinical data submitted by the sponsor, that a product with fast track designation may be effective. The
sponsor must also provide, and the FDA must approve, a schedule for the submission of the remaining sections of the NDA, and the sponsor
must pay any required user fees upon submission of the first section of the NDA. The FDA’s time goal for reviewing a fast track
application does not begin until the last section of the application is submitted.

A product may be designated as a breakthrough
therapy if it is intended to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that
the product may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. The designation
includes all of the fast track program features, including eligibility for rolling review. Additionally, the FDA may take certain actions
to expedite the development and review of breakthrough therapies, including holding meetings with the sponsor throughout the development
process; providing timely advice to the product sponsor regarding development and approval; involving more senior staff managers in the
review process; assigning a cross-disciplinary lead for the review team; and taking other steps to design the clinical trials in an efficient
manner.

<div align='center'>89</div>

The FDA may designate a product for priority review
if it is