If the company submits the MAA successfully by 11/25, it will get a 12/27 start, still within 2H 24.
As for announcing submission instead of acceptance/start, you recognize the risk. A credible company would only do that if it either had a very experienced team/TP preparing the MAA or it had already submitted unsuccessfully in a prior cycle(s), fully understood the shortcomings, and is confident it has fully addressed them. So it is possible, but those are big if's.
There are hiccups; recall the CRO delays with our AD data. And there are bigger pitfalls; see our several long missed trial-starts and the troubling AD paper delay. But given the time that's lapsed since we initiated the MAA process, I'm pretty confident we'll get it accepted in this submission cycle or next. (If we don't, it looks less like a hiccup and begins to get troubling.) Let's first see what we hear 11/28-29.
Market Data 
Markets 
AI
