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veteranseabee

09/06/19 1:52 PM

#212974 RE: Atom0aks #212972

Atom,

I realize that the FDA can call an Adcom whenever they choose in the Review cycle. I'm just curious on where we were in the meeting timetable. I think that is a certain "tell" of the reason for the Adcom.
Obviously we were all surprised by the decision, myself included but I am looking forward to the the FR, which hopefully revolves around the label. I just can't think of anything else that it would be without going to the dark side:)