Why does everyone think that a Q1 2017 launch is so crazy!? Not crazy, but if the trial enrolls on schedule my guess would be: First look around end of year with little chance of success (due, as you said, to a small alpha). Second look mid 2016. If that hits, then submission early '17 and launch fall of '17. Final analysis, winter '17 and launch 1H '18 Here is a safer prediction though. Around late summer this year we will see posts on this board that the non announcement of the first look is due to lack of events as Bavi is working. :-)