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Re: Ponch73 post# 1081

Saturday, 01/14/2017 2:33:27 PM

Saturday, January 14, 2017 2:33:27 PM

Post# of 2104
The trial was a relatively small one, hence no suprise. Moreover the efficacy indication was reached only in subgroups after post hoc analyses (NASH subgroup and all etiologies High MELD subgroups). That is why you do first a ph2a which is normally a proof of concept study and then followed by a ph2b. As a consequence of interactions with FDA , ph2b will include only the sickest NASH patients (decompensated), basically combining the two subgroups with highest efficacy, and will include also clinical endpoints , hence bypassing the stalemate of deciding if surrogate endpoints are approvable or not.

All of this was and is very clear to NVS, which used the option exercise as an incentive for CNAT mngt to start the trial asap (q2 2017)