>This is all a moot point anyway, as in many people's opinion (mine included), the CR letter was a political decision by CBER, who was inclined to approve, but caved in to CDER/OOD's threats during a crucial period for FDA/Congressional politics.<
If the survival data had been stronger, CBER wouldn’t have caved.
“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”