AK:I tend to agree with you as well. What stumps
me is that all assumptions on the Board are predicated
on Jellis, a trial with a very different dempgraphic
mostly enrolled with women, low Tigs, never accepted
by FDA as a valid clinical trial, nor to my knowledge
ever reviewed by a PEER Journal. To make it the comparator
trial for R-IT seems to me to be a leap of faith. Would
one of our knowledgeable posters please explain the rational?
Do recall that subset analysis is not considered acceptable
to FDA.