this is a bit of an unusual case because, if I understand the...

this is a bit of an unusual case because, if I understand the situation correctly, the company "acquired" their Phase III data. I don't know if that is in any way an issue, but I worked on the basis that if the data were crap the FDA would have rejected the NDA in the first place.

Here's a PDF which discusses trial success rates in general

Trial Success Rates

This doc quotes and NDA to approval rate of 85%, which is a bit less than the number I remember having seen elsewhere of 90%

So the naive estimate is that there's a 5/6 chance of success, which are reasonable odds. So far the company has said in announcements that discussions with the FDA have gone well. Now I don't want to sound snarky but in my (admittedly limited) experience every ann from every bio company I've ever read has said that discussions with the FDA have gone well. But I'm working on the basis that if there were a serious hold up the company would be obliged to have reported it by now.

There was a line in one of the anns about "reaching alignment in the final product label" which another poster on HC suggested meant there were some unresolved issues. I can't remember who that was but I'd be interested to hear their opinions in more detail on that.

In general,and I'm sure you don't need me to say this, there are no sure things in bio. But I am personally comfortable with the risk factor here.