Yes but that gets into interpretation, which I try to avoid. The PR only speaks to an agreement for the eligibility for submission of an MAA. A legitimate question is just how much review was done by the CHMP and what exactly was said behind closed doors. I am almost certain that the discussions were more than "is allowed to submit" but that is unknown to us so I don't choose to interpret Missling's comments. That's my big grip with Missling. There is the statement "And that's what we proceeded with last week accordingly". This board contains a lot of posts trying to interpret what that really means and we just ended up with a lot of interpretations, none of which are provable without further clarification from AVXL.
Thank you for this information. I would so love to be wrong. But in summary there doesn't seem to be anything in print and only a single verbal statement of a recommendation to proceed during Q&A for the quarterly cc.
From the quarterly call: At around the 2 minute mark there is a statement of submission At around the 8 minute mark during Q&A there is a statement of several meetings and recommendation to proceed with the application https://video.wixstatic.com/video/79bcf7_c8598d84565648258861db371a2527c6/720p/mp4/file.mp4 These are verbal statements behind Clints safe harbor statements.