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.
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.
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.
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....
Dendreon, The Fabled "Next Amgen" [View instapost]
analysis here
www.scribd.com/doc/342...
Dendreon and Provenge: What if We Lived in England? [View article]
www.scribd.com/doc/342...
Five Key Factors Weighing on Dendreon [View article]
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