Thanks bear....my apologies for the redundancy.  As for Koo's question about a need for muscle...I would assume the strength of a thumbs up on FA comes from the fact that its at the halfway point, after 125 events....while we've had 4 periodic reviews with positive reccomendations we don't know how far along the trial is in terms of the number of MAC events.  While we won't have a RRR number with the FA, if we get the green light at least we'll know we're half way home....