Biotech Values

[jq1234]

Previously, Estimated Study Completion Date was February 2012. Now, time to market in EU will probably be delayed. Although, the study design now incorporates planned interim analyses on the primary endpoint, so perhaps a chance for an earlier end of trial.

Not only that, in all likelihood, FOCUS will get result after ASPIRE because the former primary endpoint is OS while the later is PFS. Also ASPIRE trial carfilzomib in combination is blessed by both FDA and EMA. To me, the change to FOCUS carfilzomib single agent is not related to EMA filing.