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Dendreon, The Fabled "Next Amgen"
Did you read that trial design analysis? I think there is something to it. I feel sorry for the patients.
The control arm received 1/3 of their blood back to start with and could then get Provenge if progressed. But by receiving only 1/3 of their blood to start with, they lost LOTS of tcells. It is this loss of Tcells which could have lead to progression and then to any difference with the Provenge arm.
I don't think you've read the analysis. It is what the control arm was doing before progression which is key.
FDA should never have agreed the SPA. It is like the mess on overdosing EPOs and on Avandia. FDA did it for ethical concerns, but missed the harm the control arm was doing before crossover.
Read the analysis. YOu can die quicker, if you have less tcells...
Anyways, I'm sure FDA will look at it and draw their own conclusion.
Disclosure: Trading DNDN options, both puts and calls.
Jul 14, 2010. 05:49 AM
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