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Re: Burn Sanderson post# 216503

Friday, 09/27/2019 12:16:44 PM

Friday, September 27, 2019 12:16:44 PM

Post# of 424005
It meant a delay is highly possible. Such that no approval (even a tentative one) on 9/28. 11/14 AdCom may discuss the details of that amended sNDA (with new label). And the approval may come at Jan or Feb 2020.
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