As soon as they were submitted to the FDA, the advisory panel and the FDA itself should have gotten into a room and been able to either approve or deny within a week. If they need to work all hours of the day to cover all necessary steps, so be it. There is no sense of urgency. Really, they should have treated this type of drug development as operation warp speed 2.
There’s statutory timelines the FDA has to follow, both for speed of review, feedback, and then how the advisory process works once it starts. Just because we don’t know more doesn’t mean more isn’t going on. Maybe the study was inadequate, maybe it didn’t work well enough, maybe there were side effects. The FDA doesn’t release most of this publicly and the company tends to only release when it’s good news.
I would bet all kinds of 30 and 90 day deadlines are occurring and it’s just not the good news we want.