On subject of T-DM1, I find it hard to believe that insufficient interim data has been collected so far from two phase II trials and three phase III trials for FDA to make a provisional approval decision, while subject trials continue to provide input into final approval package.
Of course letters from Breast Cancer Action group that imply Genentech is looking for a quick out, circumvent approval process by use a so called expanded access trial in lieu of proper phase III testing and BCA's insistance that conduct of mandatory phase III trials are all incluse and have last touches put upon before final decision is made, surely don't help this issue.
http://archive.bcaction.org/index.ph...-fast-tracking