secwatch.observer — SEC 8-K summary
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Issuer:     Replimune Group, Inc. (REPL)
CIK:        0001737953
Form:       8-K
Filed at:   2023-02-27T23:59:59+00:00
Accession:  0001104659-23-025680
Event type: regulatory
Sentiment:  neutral
Materiality: 0.60
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Replimune provides FDA update on CERPASS trial; no changes to protocol or endpoints
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- FDA agreed no changes to CERPASS clinical trial protocol or data analysis plan after meeting.
- Minor changes to statistical analysis plan (SAP) unrelated to dual primary endpoints (ORR and CRR).
- Company still expects BLA submission for RP1 in early 2024, assuming positive data and overall clinical benefit.
- This update follows FDA response to draft SAP submitted in September 2022.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1737953/000110465923025680/0001104659-23-025680-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1737953/000110465923025680/tm237904d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-23-025680

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer