First Clear Signal: Day 120 List of Questions - we can't know what is in this LoQ.
If EMA reviewers are not satisfied that ATTENTION-AD is strong enough as confirmatory evidence, they'll ask about it here.
If they’re okay with it, they may ask only minor clarifications.
Second Confirmatory Point: Day 180 Outstanding Issues
If the Day 120 response isn’t convincing, the Day 180 "Outstanding Issues" list would explicitly ask for a post-marketing study or raise more serious doubts.
It is a misguided view that the CHMP Rapporteurs and Expert Team by some Regulatory Standards have seen and verified that the ATTENTION-AD data can replace the need for a confirmatory trial. If they knew these kinds of things at a glance - then what do we think they are doing during those 120 days?
IMO Boi is just concocting explanations that suits a biased view of approval chances and is putting far too much weight on the MAA being accepted FOR REVIEW!
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