[phil]

Positive article, but goes too easy on This FDA. and some in-accuracies. One of our chief complaints about them , is they decided to reject acc. appr for T DM-1., because " Pts had not exhausted all other options, ' WRONG ! Lorraine and hundreds of others HAD . They had NO mechanism to interview pts, and , the FDA reviwers refused to talk with Lorraine ! Told an FDA Pt. rep to talk , placate her. They hide behind the policy that they cannot comment on drugs under development, but they listen to Big Pharma , why not the Survivors ?? They say they have " sympathy " for " desperate " pts. ...we dont need their sympathy, if they were in our shoes they'd be deperate too, they write us off. I saw how they dis-respected the Avastin pts, they owe them , and us , one BIG apology... but much more they need to make it right ! T DM-1, Avastin , and Peruzumab. And Pert is NOT Approved for late Stage IV , only first -line , as thats the study that was completed. So another 2 + yrs may go by before late stage IV pts can get it !!