< There does not seem to me any good reason why the REMS was not completed and ready by the time of the original PDUFA date >

Reason IMO is they didn't have qualified personnel to complete it. Recall, Zeb was gone by then. I doubt the peons know right from left.


Further if you recall when they originall said it would be Q1 2010 before resubmission a number of analysts were baffled given they said batches would be complete by end of October. Way too much additional time. My guess is that they padded the timetables to account for the possibility of yet more screw ups or work that they just don't have the internal staff to complete in a timely manner. Last, I imagine they reflected on the numerous times they've screwed up cost shareholders dearly. BOTH offerings of about 16 MILLION shares were 100% unnecessary had we had a capable, sharp mgt. team in place.