Company: RVRC
Filing Date: 2025-12-12
Form Type: S-1/A
Source: 0001213900-25-121070
Chunk: 137

Company: Revium Rx.
Filing Date: 2025-12-12
Form: S-1/A
Chunk 137
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| ● | product recall, seizure or                                        
 detention, or refusal to permit the import or export of products; |

| ● | imposition of clinical holds 
 on ongoing clinical trials;  |

| ● | mandated modification of promotional                               
 materials and labeling and the issuance of corrective information; |

| ● | consent decrees, corporate                                
 integrity agreements, debarment or exclusion from federal |

| ● | fines, injunctions or the imposition 
 of civil or criminal penalties.      |

Fast Track, Breakthrough Therapy and Priority Review Designations

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