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Re: dmiller post# 198147

Monday, 06/24/2019 9:29:39 AM

Monday, June 24, 2019 9:29:39 AM

Post# of 425659
He stated by end of June at GS as the time to receive a notice

So, the question is, when would we expect notice of an ADCOM?

FDA guidelines would suggest that we’re in that window of time right now where they should be making that decision. With a September 28 PDUFA that would mean if they are going to have an ADCOM or most likely be in August. So, they should be beginning to form that committee here. Relatively soon. So, it would surprise me if we didn’t hear one way or the other. You know, before the end of June, we are proceeding on the assumption that we’re going to have one just due to the enormity of this new indication, but I can't predict exactly when.
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