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Fly News Breaks for April 13, 2016
CLVS
Apr 13, 2016 | 05:58 EDT
WallachBeth analyst Caroline Palomeque says the regulatory timeline for rociletinib is moved out to at least 2019 after an FDA panel voted 12-1 to include the TIGER-3 data. This makes rociletinib no longer eligible for accelerated approval, Palomeque tells investors in a research note. The FDA expressed uncertainty with efficacy, safety and proposed dose, the analyst adds. She has a Hold rating on Clovis Oncology.
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