RVNC— If the 100U vial if indeed a smokescreen for the filing delay, what, IYO, could be the real reason(s) for the delay?
Management may simply have underestimated the time to get the job done.
The a) and b) cases in #msg-148719175 are not wholly black and white, by the way. For example, the BLA may have been 2 months behind schedule for reasons having nothing to do with the 100U vial while work on the 100U vial may have added another month, causing a 3-month delay in all.