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 come from that preliminary clinical data