I believe we all thought that with a large trial and strong stat sig, albeit of a result with precious little clinical value, this would be a shoo-in.
Strong statistical significance when you measure pain a certain way. from page 22 of the briefing doc you can't convince me that the trial participants on drug had less pain.
The clear message from the Pazdur/Hussain/Sher/Flemming contingent in power at the FDA is they want survival data for cancer drugs.
when all is said and done this drug will not have a survival benefit. if you don't increase survival or reduce pain what is the drug good for.
The irony is Provenge had solid survival data, yet they wanted a larger trial that was pre-specified to be "sure", or, they wanted 9902B. Why would they change their stripes for GPCB?
Intermune's actimune also had a survival benefit until they ran another trial with survival as the pre-defined endpoint. Guess what, more people died on the drug
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