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DewDiligence

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DewDiligence

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Re: biomaven0 post# 213681

Saturday, 09/16/2017 5:35:34 PM

Saturday, September 16, 2017 5:35:34 PM

Post# of 251798
Re: BMY withdrawal of Opdivo MAA in HCC

That's surprising—I thought the data looked pretty good. If I recall correctly, they have a US PDUFA date later this month for this indication.

Yes, the PDUFA date is 9/24/17 (https://investors.bms.com/iframes/press-releases/press-release-details/2017/US-Food-and-Drug-Administration-Accepts-for-Priority-Review-Bristol-Myers-Squibbs-Application-for-Opdivo-nivolumab-in-Previously-Treated-Hepatocellular-Carcinoma/default.aspx ).

The problem in Europe might be CMC-related, although it would have to something recent insofar as the CHMP endorsed Opdivo as recently as Apr 2017 (#msg-130693584).

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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