regulatory
confidence high
sentiment negative
materiality 0.85
Replimune schedules Type A meeting with FDA to discuss RP1 CRL; program viability at risk
Replimune Group, Inc.
- FDA Type A meeting scheduled to discuss CRL for RP1 BLA in advanced melanoma; briefing submitted with additional analysis.
- CEO states without accelerated approval, RP1 program in advanced melanoma, including phase 3 confirmatory trial, will not be viable.
- Stockholders voted against amending 2018 Omnibus Incentive Compensation Plan (26.97M for, 35.49M against).
- All director nominees elected; PwC ratification and say-on-pay proposals approved by stockholders.
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