Here’s the thing. LP pointed out why they could not give a timeline for MAA, or for that matter FW. However, it was quite clear, to me, she was distinguishing that MAA was a near term priority, as was what she described as the MIA prerequisite. That MIA certificate was based upon the manual method. To me, she described, without using the phrase, that they had been working through a rolling review for a year, and were, by mid-October, scanning the final versions of components into the trial master file.
There are two 90 day recommended meetings. One 90 days before rolling review. One 90 days before anticipated MAA submission. (Of course it does not have to be a full 90 days)
What everyone should be asking is, when did the latter 90 day meeting occur?
News 
Market Data 
Discover 
