still sealed until 390 have been treated, then another 28 days. Nader can however pay what I think they call a penalty, and they will release data to him. Not sure if he would release it to us. Either way, we should get approval.
It it "halt and approve" right now, that's good bullish news.
If it is continue to enroll and test 390 it's still great and we should get approved, but we'd have to wait another 2 months.