Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 131

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 131
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 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.

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The FDA may designate a product for priority
review if it is a product that treats a serious condition and, if approved, would provide a significant improvement in safety or effectiveness
when compared with other available therapies. A priority review designation is intended to direct the FDA’s attention and resources
to the evaluation of such applications, and to shorten the FDA’s goal for taking action on an original NDA from ten months
to six months from the filing date.

Fast track designation, breakthrough therapy
designation, and priority review do not change the standards for approval but may expedite the development or approval process. Even
if a drug qualifies for one or more of these programs, the FDA may later withdraw or rescind the designation if it decides that the drug
no longer meets the conditions for qualification or decides that the time period for FDA review or approval will not be