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rafunrafun

04/29/19 8:40 PM

#189267 RE: OldYeller187 #189266

We’d likely learn of an AdCom at day 60/74


Why? This took 48 days and this took 55 days.

Do you know many cases that took full 60 or 74 days?
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sts66

04/30/19 1:50 PM

#189337 RE: OldYeller187 #189266

AMRN did not learn about the FDA's decision to hold an Adcom for ANCHOR until 80 days had passed - sNDA submission was March 28, Adcom was announced on June 19, meaning it wasn't in the 74 day letter. If R-IT gets PR that might change the timing, dunno about that.