FDA briefing docs question RP1 efficacy, driving REPL 20% premarket drop
- Negative FDA docs released for July 30 CTGTAC AdCom meeting
- Review team: BLA lacks adequate evidence of substantial effectiveness
- Cites single-arm IGNYTE trial flaws, confounding with nivolumab
- Echoes prior 2025 CRL and April 2026 second rejection
- PDUFA date is August 2; AdCom likely sways approval odds
- Stock closed July 27 down 11% at $8.63 before further plunge
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