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Fly News Breaks for April 8, 2016
CLVS
Apr 8, 2016 | 11:00 EDT
Stifel analyst Thomas Shrader calls the FDA briefing documents ahead of its advisory committee meeting for Clovis' cancer drug rociletinib "awful" and he believes the agency is looking to delay a decision until after the TIGER-3 data are available and provide more data on dosing. The "biggest surprise" from the documents was the FDA suggestion of a black box warning based on cardiac issues, Shrader said. The analyst thinks "the drug is dead" and that the company will stop most of the ongoing trials, except possibly combination trials with PD-L1 inhibitors that may allow a partnership for the drug. Shrader has a Buy rating and $30 price target on Clovis shares.
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