Ann: FDA Strategy and Regulatory Update, page-66

Sorry I am confused (and that is easy to do). The approval that everyone is expecting is

Can you break it down for me because I for one don't completely understand this. Its an incredibly poorly written announcement.

1) Am I correct in saying the FDA approval that everyone has been banging on about on HC for the last month or so is not the De Novo Depressive Burden application. The way that press release reads to me is that a submission has yet to be made to the FDA on De Novo because the analysis has been held up because of COVID.

2) If it is the FDA approval for Mebsleep everyone is getting excited about it is saying that clarifications are underway for the FDA to "Officially accepted for Review". If it has not been officially accepted for review, then how can an Approval be close in any way shape or form?

What am I missing here? I hope I am missing something by the way!!!