FTM, doesn't it pose any problems that the control arm goes even lower then 5.6?
If I remember well there was only one historical control arm MOS that was below ours, all the others where more direction 7 Months.
Going even lower then 5.6 months could raise questions, unless the patients in the historical SOC+placebo arms where in better condition then the L3/L4 enrolled ones in our CT.
If I would be the FDA I would in all cases, ones historical comparison data is available as is the case here, investigate results that are not in range of historical statistics.