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north40000

05/29/19 3:55 PM

#194029 RE: KCSVEN #193925

What is the next scheduled time for an AdCom that is available in CVD arena? Or is the schedule flexible, depending on individual members of AdCom being available?

sts66

05/30/19 3:05 PM

#194244 RE: KCSVEN #193925

We should hear on Adcom or not by June 10 the latest. They try to have that announced by day 74.



Where did you find that, or is it a guess? I've never seen anything that says Adcom has to be announced by day 74, which would coincide with the 74 day letter for SR, meaning FDA would release both on the same day - but it took them two months to inform AMRN that ANCHOR would require an Adcom, and I'm sure there are plenty of other examples showing a 1-2 month delay between granting of PR or SR and decision to hold an Adcom.