Gestalt..in defering to you...I would only say... I am tired of hearing about endpoints hit or missed...the recent intended "hit" piece by the FDA only proves they are NOT trying to be helpful in any way...IF, it was one of their Annual funding Pharma/partners...asking, I am fairly sure...the conversation would likely be very different...
We seem to be the orphan in the orphanage asking for more gruel...and they like to say...not for you.
Take the USA...FDA out of the equation for the moment and think International...where we can do a lot of good things... that are not hamstrung...by the schoolmasters refusing us...Any gruel. When they call us back... perhaps we can help build them a NEW orphanage of equity for all.