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CLVS > down 60% pre-market...Clovis Oncology Announces Regulatory Update for Rociletinib NDA Filing

http://finance.yahoo.com/news/clovis-oncology-announces-regulatory-rociletinib-130000272.html

In the intent to treat analysis of the 79 patients in the 500mg dose group, the current confirmed response rate is 28 percent, and 34 percent in the 170 patients in the 625mg dose group, with an encouraging duration of response in both doses. The most frequent reasons that patients’ responses were not confirmed in a subsequent scan were due to progression, often due to brain metastasis, and due to subsequent scans not demonstrating tumor shrinkage greater than 30 percent.

The Company anticipates that the review of this additional information will result in a delay of a potential approval. This additional review could lead to an extension of the Company’s March 30, 2016 Prescription Drug User Fee Act (PDUFA) date.