Company: RVRC
Filing Date: 2025-12-12
Form Type: S-1/A
Source: 0001213900-25-121070
Chunk: 139

Company: Revium Rx.
Filing Date: 2025-12-12
Form: S-1/A
Chunk 139
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. Products granted accelerated
approval must meet the same statutory standards for safety and effectiveness as those granted traditional approval.

The FDA’s approval of a candidate product
under the accelerated approval pathway is usually contingent on a sponsor’s agreement to conduct post-approval confirmatory studies
to verify and describe the product’s clinical benefit, and the FDA may require such studies to be underway prior to approval. Failure
to conduct required post-approval studies, confirm a clinical benefit during post-marketing studies may result in the FDA’s withdrawal
of the product from the market on an expedited basis. All promotional materials for therapeutic candidates approved under accelerated
regulations are subject to prior review by the FDA.

Orphan Drug Designation and Exclusivity

Orphan drug designation in the United States
is designed to encourage sponsors to develop products intended for treatment of rare diseases or conditions. In the United States, a
rare disease or condition is statutorily defined as a condition that affects fewer than 200,000 individuals in the United States or that
affects 200,000 or more individuals in the United States and for which there is no reasonable expectation that the cost of developing
and making available the drug or biologic for the disease or condition will be recovered from sales of the product in the United
States.

Orphan drug designation qualifies a company for
tax credits and market exclusivity for seven years following the date of the product’s marketing approval if granted by the
FDA. An application for designation as an orphan product can be made any time prior to the filing of an application for approval to market
the product. If orphan drug designation is granted by the FDA, the generic identity of the therapeutic agent and its potential orphan
use are disclosed publicly by the FDA. After FDA grants orphan designation, the product must then go through the review and approval
process like any other product.

A sponsor may request orphan drug designation
of a previously unapproved product or new orphan indication for an already marketed product. In addition, a sponsor of a product that
is otherwise the same product as an already approved orphan drug may seek and obtain orphan drug designation for the subsequent product
for the same rare disease or condition if it can present a plausible hypothesis that its product may be clinically superior to the first
drug. More than one sponsor may receive orphan drug designation for the same product for the same rare disease or condition, but each
sponsor seeking orphan drug designation must file a complete request for designation.

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If a product with