Replies to post #213681 on Biotech Values

[DewDiligence]

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).