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james murphy

11/06/19 1:43 PM

#223308 RE: BioChica #223303

Jesus are you telling us no matter how great the Adcom result we will sit down with family for Christmas dinner knowing that Amrn has a 22% of not getting Label.The lady that stole Christmas Bio China .LOL
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KCSVEN

11/06/19 2:06 PM

#223317 RE: BioChica #223303

True but almost 100% of the time they go along with a no vote, about 25% of the time they go against a yes vote, however, I don;t see stats for unanimous yes votes they go against and we are likely going to be in that camp, my guess is that is very low.
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Tal10

11/06/19 3:02 PM

#223334 RE: BioChica #223303

Where are you finding your statistics? From my findings, in the past 10 or so years, when the advisory committee votes for approval, the FDA has voted against the panel in only 6% of the applications.