[phil]

Important addendum. Gen. is adding a large new trial to try to satisfy this FDA 's new focus on " Overall Survival ",( I call it " Slow As Usual "), at 42 sites, comparing t dm-1 to other txs. None of this should have happened, if ever adrug deserved accelerated approval, it was this drug. Starting in 2010, this FDA began slowing down the process, just as this breakthrough drug was ready.
They refused to see what they had already pre-determined they would not see. Interesting that they began the process of revoking Avastins approval at the same time .
They need to be fixed from above. This is President Obamas FDA, and this Congress's FDA. Make sure you let your reps, and the Congressional " HELP" Committee know how you feel about this FDA. Once they know, then they own it. Its theirs. In an election year. 46,00 women and men will die fron breast cancer this year, and this FDA is slower, more contradictory than ever...