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DewDiligence

12/07/15 8:58 AM

#198015 RE: ciotera #198011

ABBV—10% CR [for Venetoclax] is a failure. Imbruvica probably has that much. So, it's a success as far as it's approvable based on this study, but how will it compete against Imbruvica?

Good question. Moreover, Venetoclax’s SAEs were somewhat troubling.
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DewDiligence

01/12/16 10:47 AM

#199009 RE: ciotera #198011

ABBV/Roche—Venetoclax NDA in second-line CLL accepted by FDA with priority review; corresponding MAA validated by EMA:

http://finance.yahoo.com/news/u-european-regulators-accept-applications-133000651.html

The PDUFA date should be on or about 7/11/16.