Can't fault the CHMP for saying CM_227 was too convoluted to evaluate.
The US sBLA based on the same CHECKMATE-227 data is (somewhat surprisingly, IMO) under review by the FDA with a PDUFA date of 5/15/20 (#msg-153308881).
Note: The CHECKMATE-9LA study, in which the Opdivo/Yeryoy arm included two cycles of induction chemotherapy (#msg-151836584) will be part of separate applications (i.e. distinct from CHECKMATE-227) in both the US and EU. This is confirmed in the above PR.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”
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