Company: RVRC
Filing Date: 2025-12-12
Form Type: S-1/A
Source: 0001213900-25-121070
Chunk: 134

Company: Revium Rx.
Filing Date: 2025-12-12
Form: S-1/A
Chunk 134
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 the product, the proposed
labeling and other relevant information, are submitted to the FDA as part of an NDA requesting approval to market the product for one
or more specified indications. Clinical and preclinical data may come from company-sponsored trials or from a number of alternative sources,
including studies initiated by investigators, and the NDA must include any negative and ambiguous results, as well as positive results.
To support marketing approval, the data submitted must be sufficient in quality and quantity to establish the safety, purity, and potency
of the investigational product to the satisfaction of the FDA. For most NDAs, the sponsor is required to pay a substantial application
user fee at the time of submission and the sponsor of an approved NDA is subject to an annual program fee. Certain exceptions and waivers
are available for some of these fees, such as an exception from the application fee for products with orphan designation and a waiver
for certain small businesses.

The FDA has 60 days after submission of
the application to conduct an initial review to determine whether to accept it for filing based on the agency’s threshold determination
that it is sufficiently complete to permit substantive review. If the submission has been accepted for filing, the FDA begins an in-depth
review of the application. Under the goals and policies agreed to by the FDA under PDUFA, the FDA has ten months from the filing
date in which to complete its initial review of a standard application and respond to the applicant, and six months for a priority
review of the application. The FDA does not always meet its PDUFA goal dates for standard and priority NDAs and the review process may
be significantly extended by FDA requests for additional information or clarification.

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During its review of a NDA, the FDA may refer
applications for novel pharmaceutical products that present difficult questions of safety or efficacy to an advisory committee. Typically,
an advisory committee is a panel of independent experts, including clinicians and other scientific experts, that reviews, evaluates and
provides a recommendation as to whether the application should be approved and under what conditions, if any. The FDA is not bound by
the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions. Accordingly, there
can be no assurance that a favorable advisory committee recommendation, if obtained, will result in FDA approval.

On the basis of the FDA’s evaluation of
the application and accompanying information, including the results of the inspection of the manufacturing facilities and any FDA audits
of preclinical