Replimune · Nasdaq: REPL · RP1 (vusolimogene oderparepvec)

RP1 after the FDA's letters: the record, reconstructed.

Two Complete Response Letters, a resubmission, an advisory committee and an accelerated approval. What changed after each FDA decision, across Replimune's filings, in 16 questions answered from 11 source documents.

Quotes an FDA letterQuotes a company filingA line joins two questions whose answers quote the same passage. Hover a question to trace it.

What did the FDA tell Replimune before the BLA was filed?2021 – 2024What did the FDA tellReplimune before the BLA wasfiled?2 documents · 2 connectedWhat did the FDA's first letter object to?JUL 2025What did the FDA's firstletter object to?1 document · 3 connectedHow did Replimune describe the first letter?JUL 2025How did Replimune describethe first letter?2 documents · 3 connectedWhat was said at the September 2025 Type A meeting?SEP 2025What was said at theSeptember 2025 Type Ameeting?6 documents · 3 connectedWhat did Replimune resubmit in October 2025, and what did the FDA make of it?OCT 2025What did Replimune resubmitin October 2025, and what didthe FDA make of it?3 documents · 4 connectedWhat happened to the confirmatory trial Replimune said would not be viable?JUL 2025 – AUG 2026What happened to theconfirmatory trial Replimunesaid would not be viable?7 documents · 5 connectedWhat did the FDA's second letter object to?APR 2026What did the FDA's secondletter object to?2 documents · 4 connectedWhy did a different FDA team review the resubmission?APR 2026Why did a different FDA teamreview the resubmission?2 documents · 1 connectedWhat changed between the FDA's first and second letters?JUL 2025 → APR 2026What changed between theFDA's first and secondletters?3 documents · 3 connectedHow did Replimune's 8-K describe the FDA's second letter?APR 2026How did Replimune's 8-Kdescribe the FDA's secondletter?2 documents · 4 connectedWhen did injected lesions become an FDA concern?2021 – 2026When did injected lesionsbecome an FDA concern?5 documents · 4 connectedWas the FDA's advice to Replimune consistent?2021 – 2026Was the FDA's advice toReplimune consistent?4 documents · 4 connectedWhat happened inside Replimune after the second letter?APR – JUN 2026What happened insideReplimune after the secondletter?3 documents · 2 connectedHow did RP1 go from a second FDA letter to accelerated approval in four months?APR – AUG 2026How did RP1 go from a secondFDA letter to acceleratedapproval in four months?4 documents · 4 connectedWhy do RP1's reported response rates range from 24.2% to 34%?2021 – 2026Why do RP1's reportedresponse rates range from24.2% to 34%?5 documents · 2 connectedWhat remains unresolved after RP1's accelerated approval?AUG 2026 –What remains unresolved afterRP1's accelerated approval?3 documents · 2 connectedWhat did the FDA's first letter object to?JUL 2025What did the FDA's first letterobject to?What did the FDA tell Replimune before the BLA was filed?2021 – 2024What did the FDA tell Replimunebefore the BLA was filed?How did Replimune describe the first letter?JUL 2025How did Replimune describe thefirst letter?What was said at the September 2025 Type A meeting?SEP 2025What was said at the September2025 Type A meeting?What happened to the confirmatory trial Replimune said would not be viable?JUL 2025 – AUG 2026What happened to the confirmatorytrial Replimune said would not beviable?What did Replimune resubmit in October 2025, and what did the FDA make of it?OCT 2025What did Replimune resubmit inOctober 2025, and what did theFDA make of it?What did the FDA's second letter object to?APR 2026What did the FDA's second letterobject to?What changed between the FDA's first and second letters?JUL 2025 → APR 2026What changed between the FDA'sfirst and second letters?How did Replimune's 8-K describe the FDA's second letter?APR 2026How did Replimune's 8-K describethe FDA's second letter?Why did a different FDA team review the resubmission?APR 2026Why did a different FDA teamreview the resubmission?What happened inside Replimune after the second letter?APR – JUN 2026What happened inside Replimuneafter the second letter?When did injected lesions become an FDA concern?2021 – 2026When did injected lesions becomean FDA concern?Was the FDA's advice to Replimune consistent?2021 – 2026Was the FDA's advice to Replimuneconsistent?How did RP1 go from a second FDA letter to accelerated approval in four months?APR – AUG 2026How did RP1 go from a second FDAletter to accelerated approval infour months?What remains unresolved after RP1's accelerated approval?AUG 2026 –What remains unresolved afterRP1's accelerated approval?Why do RP1's reported response rates range from 24.2% to 34%?2021 – 2026Why do RP1's reported responserates range from 24.2% to 34%?

Cross-investigations involving Replimune

Questions that connect Replimune's record with other companies'.

All cross-investigations →

Prepared from public FDA letters and SEC filings: every quoted passage is matched to the original document, and every “not in” statement comes from a search of the whole document, before it is published. Questions, summaries and connecting sentences are EphemerisX’s wording. Not investment advice. How this research works → · Ask the FDA and SEC Ephemeris →