Keith Rettig

Clarifying the Issues Surrounding Dendreon's Provenge

Absolutely well done. Thank you very much for the research and all the linking. Very helpful.

Dendreon: Don't Forget About Risk vs. Reward

It should be clearly noted that the FDA did NOT change the question of efficacy. They merely defined what they meant. The first three panel members interpreted the question to mean "determined, proven, without a doubt, etc.". The first three all said they wanted Provenge in the hands of the patients but that they couldn't agreed that the efficacy of the drug was established without doubt from the current research.
It was then that the panel chair asked the FDA for clarification. The FDA clarified that they wanted to know "if the data provided substantial evidence". This is not changing the question; this is defining what they meant.
I was quite impressed with how this played out. It clearly shows that the CBER panel is thinking of the patients as well as the quality of the product; and thus performing exactly as the FDA wants them.
I strongly agree with 'echo toall' regarding that this would seem to indicate the FDA's intentions for approval.