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sts66

02/07/14 4:55 PM

#25150 RE: ziploc_1 #25140

I'm sure it's correct - recall the stunned CC after the Adcom when Joe Bruno said "it's common to get your target population on the label prior to completing a long term trial to prove it", or something to that effect? So he didn't say it specifically, but most interpreted it to mean that they over-reached and went for REDUCE-IT language on the ANCHOR label.