Biotech Values

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Onyx Pharmaceuticals Announces Plans to Amend Phase 3 FOCUS Study for European Registration

No one had made comment on this development. I'll give it a try.

There are a couple of possibilities:

1. Since the trial was open label, it is possible ONXX sensed it might not achieve original PFS primary endpoint either due to small sized trial (80 patients) or other reason, thus amend the trial with larger sample size (300 patients) and OS as primary endpoint.

2. ONXX is uneasy with the recent tough talk of accelerated approval out of ODAC and FDA, thus want to play safe by amending the trial to achieve two possible goals: one is in case NDA for accelerated approval is rejected, this study can step in; two is in case FDA insists confirmatory trial to be substantial underway before granting accelerated approval to carfilzomib, this study can be used as confirmatory trial.

I lean toward possibility number 2.