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  • Dendreon, The Fabled "Next Amgen"  [View instapost]
    DNDN: Fatal problem in trial design. Placebo patients only got 1/3 blood back. so many fewer immune cells back. This new analysis suggests harm in pdo arm could be cause of effect. Going to cause BIG headache.

    analysis here
    www.scribd.com/doc/342...
    Jul 13, 2010. 04:28 PM | 1 Like Like |Link to Comment
  • Dendreon and Provenge: What if We Lived in England? [View article]
    Looks like things going to get tricky again. Fatal flaw in trial design. placebo patients only got back 1/3 of their blood so WAY fewer immune cells -- could explain whole effect. Have seen this analysis which prob submitted to FDA.

    www.scribd.com/doc/342...
    Jul 13, 2010. 04:23 PM | Likes Like |Link to Comment
  • Five Key Factors Weighing on Dendreon [View article]
    Very sorry for patients. However, big big issues coming up in trial design. Placebo patients lost a lot of tcells that Provenge patients did not — expect FDA might re-examine this one. It looks like placebo arm could have been harmful.

    Full analysis here if interested:

    Provenge Analysis
    mfi.re/?zdiewnyttqg4vnz
    www.scribd.com/doc/342...

    Looks like pbo patients only had 1/3 blood back, ie many fewer tcells -- so they had a weaker immune system -- you can argue the 4 month effect seen was because of the harm/death in pbo not any effect in provenge arm....

    Have seen the new analysis been submitted to FDA
    Jul 13, 2010. 04:06 PM | 2 Likes Like |Link to Comment
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