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Re: shamblinthru post# 3018

Sunday, 04/15/2007 3:44:43 PM

Sunday, April 15, 2007 3:44:43 PM

Post# of 12660
It is all very clear Now!

Has the FDA already made up its mind about Provenge?

The short answer to that question is a resounding ,"yes"
The past 6 months or so was all pre designed by the FDA to give Provenge a Conditional Approval subject to final results of 9902B which is designed to complete enrollment at the time of "approval".At that point because patients would be infused at radomization,the primary end point is Survival and Cox analysiis is to be employed. All these items correct the original problems and act as a CYA orchestration. And finally to insure that everything works smoothly CBER will make the decisionon Approval or denial along with this is the new proposed draft on Conflicts of Interest regarding consulting fees from Big Pharma. The whole plan was and is beutifully designed to "thwart the Shorts"developed by a no nonsence guy called " Andy". I hope to shake his hand one day for the THANKS he deserves from all of us and all Cancer patients.
And further this is why the hiring continues unimpeaded . Dendreon is going to be ready to "hit the ground running"!


fund the cure

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