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