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Re: longusa post# 17794

Thursday, 08/21/2014 5:22:36 PM

Thursday, August 21, 2014 5:22:36 PM

Post# of 689475
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.
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