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Keeping Track: The Breakthrough Designations Of Summer Eschew Phase I

 
• By Bridget Silverman

The latest breakthrough therapy designation announcements from the Pink Sheet’s US FDA Performance Tracker

Keeping Track Feature image

The new breakthrough therapy designations announced over the last two months were all part of a remarkable streak: Every BTD announced in June and July 2020 went to products with Phase II or later data, according the data compiled by the Pink Sheet’s Breakthrough Designation Tracker.

The two-month shutout of Phase I data is a shift from the historical average that has seen about a third of the designations by the US Food and Drug Administration...

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