Company: RVRC
Filing Date: 2025-12-12
Form Type: S-1/A
Source: 0001213900-25-121070
Chunk: 138

Company: Revium Rx.
Filing Date: 2025-12-12
Form: S-1/A
Chunk 138
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 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 shortened.

Accelerated Approval Pathway

The FDA may grant accelerated approval to a product
candidate designed to treat a serious or life-threatening condition that provides a meaningful therapeutic advantage to patients over
existing treatments based upon a determination that the product has an effect on a surrogate endpoint that is reasonably likely to predict
clinical benefit. For the purposes of accelerated approval, a surrogate endpoint is a marker, such as a laboratory measurement, radiographic
image, physical sign, or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit. The
FDA may also grant accelerated approval for such a condition when the product has an effect on an intermediate clinical endpoint that
can be measured earlier than an effect on irreversible morbidity or mortality (“IMM”), and that is reasonably likely to predict
an effect on IMM or other clinical benefit, taking into account the severity, rarity or prevalence of the condition and the availability
or lack of alternative treatments.

The accelerated approval pathway is most often
used in settings in which the course of a disease is long, and an extended period of time is required to measure the intended clinical
benefit of a product, even if the effect on the surrogate or intermediate clinical endpoint occurs rapidly