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Pyrrhonian

08/21/14 5:22 PM

#17795 RE: longusa #17794

Good highlights, long. Direct could very well follow the same pathway. ORR is an acceptable surrogate endpoint especially for indications where there is no SOC.

Also, Breakthrough Therapy designation has basically been a green light for eventual approval (all that have received this from FDA saw eventual approval). If Direct is granted this (and/or EMA's Adaptive Licensing) = huge effect on pps.