Defending Biologic Drug Approval Endpoints in Public FDA Advisory Hearings
FDA Advisory Committee (AdCom) panel votes determine commercial drug survival. Discover how Chief Medical Officers present Progression-Free Survival (PFS) endpoints under intense panel cross-examination.
Amit KasliwalCEO & Founder, Dehurdle
March 30, 20234 min read
The Statistical Risk-Benefit Presentation
Recommended Spoken Script
What to say to the panel: "The clinical benefit is demonstrated by a statistically robust 4.8-month improvement in median Progression-Free Survival with a Hazard Ratio of 0.62 ($p < 0.001$). In a patient population with zero approved second-line therapies, this efficacy endpoint represents a transformative therapeutic advance with a manageable, non-cumulative toxicity profile."
The 2-Minute Practice Drill
2-Minute Spoken Drill
The 2-Minute Practice Drill
Practice FDA AdCom panel Q&A in Dehurdle.