Re: From the NEJM: The FDA's New “Breakthrough Therapy” Designation
more FDA personnel will not prevent the top fda officials from losing sight of the true objective - to save lives. they got in a battle with pharma over avastin , and were biased against t dm-1 , which was being developed by the same co. . every top researcher in the world knew t dm-1 was a game changer , for 20-30 % of the sickest to start , like my wife. for more as its deployed earlier. fda ignored the docs. would more fda staff have made a difference ? Nope. Just last month Dr. Krop at farber was quoted " T dm-1 early approval should have been a SLAM DUNK, instead it took 7 yrs. " If there had been a true Stage IV advocacy grp on the FDA advisory committees back in 2009 , avastin would have at least been kept approved for tnbc. t dm-1 in 2010 would have been approved. I estimate 8,500 lives would have been saved between 2010 -2013. perjeta would be apr. for stage iv now, pd0332991 by end of next yr at latest. having representation at top level of FDA is our dream. we won't give up.
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