Really nice explanation by Sally Church's Pharmastrategyblog as to why the FDA likely decided to reject Roche's application for accelerated approval with T-DM1.
via www.pharmastrategyblog.com
Re-Posted by Bruce Lehr August 27th 2010.
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08/27/2010
FDA rejects the Roche Immunogen T-DM1 accelerated approval filing
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Additional take on this from Ohad Hammer at Seeking Alpha
http://seekingalpha.com/article/223275-immunogen-what-really-happened-with-t-dm1s-filing
Posted by: bigredbruce | 09/01/2010 at 09:37 AM