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Breakthrough Therapy Designations: Phase II Data Is Sweet Spot For US FDA Award

 
• By Bridget Silverman

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.

Blue Lightbulbs

Breakthrough therapy designations are most commonly awarded on the basis of Phase II data, an analysis by the Pink Sheet shows. Nonetheless, a sizeable minority of designations – nearly one-third – are awarded on the basis of data from pivotal-stage clinical trials, later in the development process than the architects of the breakthrough program had envisioned.

As the BTD program enters its eighth year, the FDA has granted more than 350 designations. The Pink Sheet has identified 330 BTDs, searchable on the

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