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JohnWayne

06/16/16 10:14 AM

#202068 RE: DewDiligence #202066

Wow, the hits just keep coming for PD-1. Surprised that they also hit OS secondary, I believe the trial even allowed crossover. Would expect BMS to release a similar announcement quite soon for CheckMate 026 -- could be positive at a broader PD-L1 cutoff but remains to be seen.
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DewDiligence

06/27/16 10:07 AM

#202224 RE: DewDiligence #202066

CHMP approves MRK’s Keytruda in second-line NSCLC with positive (≥50%) PD-L1 expression:

http://finance.yahoo.com/news/merck-receives-chmp-positive-opinion-100000977.html
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DewDiligence

09/07/16 10:54 AM

#204137 RE: DewDiligence #202066

MRK—PDUFA date for Keytruda in first-line NSCLC is 12/24/16 (with priority review):

http://finance.yahoo.com/news/fda-accepts-supplemental-biologics-license-104500263.html

FDA also awarded this program BTD.