Re: We have to CHANGE the question from WHEN to WHY?
Long...before you posted I went looking for their Dec '19 presentation. They ( apparently) take those presentations down after 6 months or so. That made me decide go practice some golf then reach out to you to see if you still had the whole presentation. LUCKY for us...you DO!.
Thx for this detailed review of that presentation. I do agree with you the reason, most likely, why they did the data mining is because they are at a scientific conference, one specifically dedicated to Alz...so, I believe they HAD to make that analysis.
Correct in my mind too that acad inadvertently changed the evaluation criteria.I believe FDA would have requested this anyway. Now, on the assumption this segregated data appears in the sNDA, WHY wasn't it addressed, and/or raised as a concern by agency?...until the last week of review time?
Agency likely did discuss it with ACAD, company provided their answers ( company likely didn't get any hint of agency discomfort). Then, back at the agency office, in light of the data, led them to conclude:" a deficiency that precludes further discussion of labelling".
We await Type A outcome.