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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
    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.
    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

    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