[schoonder]

Phil,
Wouldn't it be wonderful if FDA took a close look at 1st-line mBC phase II data, where median PFS 14.2 months vs. SOC 9.2 months, reduced probability of disease progression or death by 41 percent , with much improved tolerability profile.

To apologize and even more so compensate for T-DM1's UNNECESSARY three year delay of 2nd line mBC Her2+ approval, by Feb 2013 as latest, approve this agent for ALL mBC Her2+ settings with caviat that Marianne phase III and Th3resa trials continue their runs to successful completion.
Sufficient data from these two ongoing trials is already available to justify world of benefits that can be realized by providing for an early release of T-DM1. It's time for that government agency to become more pro-active.