>>accelerated approval... single-arm study<< Call me drinking the koolaid, this is not unheard of for disease with serious unmet medical need, I can think of one example. The initial SPA of ipilimumab was for a single-arm study demonstrating 10% response rate. Unfortunately that trial missed the 10% mark by a hair - but BMY lucked out eventually with two more randomized phase III trials showing survival benefit.
P.S. There are many MEDX contingencies that joined CLDX before or after the BMY/MEDX merger .
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