I sure hope that The Dorb mangement team reads these posts, if they do not they should or let you on the board for the next meeting Oct 21th. You seam to realize all the mistake they made and in my mine they could use your help.
<"the 10 day garantee period was not a secondary endpoint so I don't think that is part of any fda analysis">
They cannot ignore it either, because their legal standard is "substantial evidence of efficacy"
Their is nothing in the FDAMA Law that says "thou shalt meet thy primary endpoint and thy can take they lucky secondary endpoint and thou shalt shove it"
In fact "primary endpoint" & "secondary endpoint" are not even mentioned in the Law
ps: what are you thinking ? do you feel it's a 50-50 or better ?