This is really the most important thing to understand: 1) they knew that none of the information that was published over the last year could be in the filing and available for consideration,2) they knew all the open issues and what was important to CHMP and 3) they went all the way anyway.
So, was this the plan all along: go through the process, get dinged, then take the 6-7 month hit and win on appeal thereby foreshortening the process because you didn't have to wait until Dec 2025 to file? Or were they guided to understand that they had to follow the same painful path that Biogen and Lilly had to follow?
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