Rather than just adding inane comments to this thread why not come up with some constructive points per the author's request. @otherperspective has pointed out in another thread the inconsitency of the FDA's decision in relation to other similar treatments (allowing single arm studies). Very important points that would serve MSB well in their meeting.
I've pointed out the inconsistency of this ruling given they have never overturned a positve ODAC decision in the last 61 cases (why this one?):
https://www.mayoclinicproceedings.org/article/S0025-6196(19)31041-9/fulltext
I am sure MSB will point to these points in their meeting, but it might not hurt for one of us to send a CONCISE email to the IR manager to insure they do (helping the cause). If anyone else had some positive and constructive points that might bolster MSB's arguments, this is the thread to INTELLIGENTLY post them on.
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