Replies to post #117284 on Biotech Values

[poorgradstudent]

ONXX:

Previously, Estimated Study Completion Date wasFebruary 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.

I agree.

I just think that this move is simply a conservative one seeing as how ONXX is no longer so destitute that they have to try and string together a registration package using an 80 patient trial. I suspect the comfort with the delay may also reflect management's viewpoint that the revenue to come from Europe is modest.

Either way I don't think this is too big a deal.

[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.