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ariadndndough

07/20/11 8:48 AM

#10790 RE: DonShimoda #10752

don or biomaven here is excerpt from the report care to comment on this.

ARIA is required under FDA statutes to conduct a confirmatory study to support
accelerated approval of ponatinib, and this study must be negotiated with the FDA
prior to approval. While multiple design metrics are under debate, the company
plans to conduct a study in newly diagnosed patients vs market leader Gleevec
starting in mid-2012. Although this design may satisfy regulators, we believe it
will provide limited marketing firepower to secure meaningful frontline share