RE:Volume. What kind of dummies would accept a BLA, set an absurdly overextended date of 6-months, call it priority review, and then after 5 full months of "assessment", can't make a yes or no decision when their OWN PEOPLE THAT HAVE PAID THEIR SALARIES FOR YEARS, sit around dying of cancer without any options but bladder removal. It's no wonder that the rest of the world can't govern anything themselves either. The most powerful country on the planet is dysfunctional on a level that's flat out embarrassing. WAYYYY too many educated people to conjure a system that sucks this bad.
Six in months after THEY accepted the complete BLA, and they can't come up with yes or no. Their diplomas, much like their ability to help, are worthless