Basically then it boils down to one trial with unimpeachable Significance and a smaller one with an unimpeachable Trend.
And the smaller one seems to have some population bias.
Substantial Evidence for Clinical Benefit ? I think Yes on balance.
Ergo .............. I think we will enjoy both the Dance and the Party too.
One Caveat - the Questions - the Votes are almost a footnote; I would say the FDA is reserving its Rights if the vote can be termed inconclusive at all. But what's on their mind ?
"....on the biotech battle-field, you need some élan...."