Source facts
FDA's complete response letter contains source-text evidence related to Clinical efficacy and substantial evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
US FDA source recordCRL · Complete Response Letter
vusolimogene oderparepvec — FDA Complete Response Letter (125827)
Issued to Replimune, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
July 21, 2025Application
Other • 125827
Product
vusolimogene oderparepvec
Company
Replimune, Inc.
Review center
CBERStage
Final Decision
Response due
July 21, 2026
Assyro regulatory brief
FreeWhat did FDA decide for vusolimogene oderparepvec?
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Key details in this letter
- 1Clinical efficacy and substantial evidence: 3 source-text matches.
Clinical efficacy and substantial evidence
Suggested next step
Review the exact redacted FDA letter and address each stated deficiency before resubmission.
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Common questions about the vusolimogene oderparepvec complete response letter
What does this complete response letter mean for vusolimogene oderparepvec?
Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Replimune, Inc. on July 21, 2025.
What is 125827?
125827 is the application under which FDA issued this complete response letter for vusolimogene oderparepvec to Replimune, Inc.. It was reviewed by FDA CBER. The letter is dated July 21, 2025.
What happens after an FDA complete response letter?
FDA will not approve the application in its present form. The sponsor can resubmit after addressing every deficiency listed in the letter — which starts a Class 1 (two-month) or Class 2 (six-month) resubmission review clock — withdraw the application, or request an opportunity for a hearing.