Breakthrough Therapy Designations: Phase II Data Is Sweet Spot For US FDA Award
Pink Sheet analysis finds that evidence from early-stage trials supports most BTD requests, but about three in 10 designations are granted on the basis of pivotal-stage data.
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Keeping Track: Breakthroughs Of Summer Break Ground In Psychiatry, Cancer (Especially Nasopharygeal Cancer) And Vaccines
US FDA’s marquee expedited review program added 15 new breakthrough therapy designations between June and August.
Popular expedited review program results in a higher approval rate than the related fast track designation, but the COVID-19 era is seeing a drop in designations and a rise in complete response letters for BTD programs.
The latest breakthrough therapy designation announcements from the Pink Sheet’s US FDA Performance Tracker