Replimune (REPL) Group announced that the company completed a Type A meeting with the U.S. Food and Drug Administration on September 16th to discuss the complete response letter (CRL) for the Company’s Biologics License Application for RP1 in combination with nivolumab for the treatment of advanced melanoma. The company is evaluating the feedback from the FDA provided during the meeting to determine next steps. At this time, a path forward under the accelerated approval pathway has not been determined. “The feedback from the melanoma community, including patients and physicians, clearly highlights the unmet need in advanced melanoma and the compelling risk-benefit profile of RP1 observed in the IGNYTE trial,” said Sushil Patel, CEO. “We remain committed to working with the FDA to determine an expeditious path forward for RP1.”
Elevate Your Investing Strategy:
- Take advantage of TipRanks Premium at 55% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence.
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Read More on REPL:
- Replimune Group Schedules Crucial FDA Meeting for RP1
- REPL Lawsuit Alert! Class Action Lawsuit Against Replimune Group
- Replimune announces Type A meeting scheduled with FDA
- Video: Nvidia, AMD said to pay U.S. 15% of revenue from China chip sales
- Replimune Group Reports Increased Losses Amid Rising R&D Costs