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DewDiligence

05/27/15 11:10 AM

#191746 RE: jbog #191727

ABBV/ENTA also plan to apply for GT2 Japanese approval by year-end 2015. The submission will be based on the GIFT-2 study (#msg-95444387).

dewophile

05/27/15 12:00 PM

#191752 RE: jbog #191727

From the release it sounds like the first trial only enrolled non-ciorrhotics w high baseline VL, so the 95% SVR has to be taken in that context. Not sure about the randomized portion, but the 98% here helps compete w GILD (GILD had 100% SVR in a somewhat smaller trial)
I don't think the cirrhotic data is competitive w GILD though