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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.

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