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Alias Born 05/20/2007

Re: scha6ab post# 3730

Tuesday, 05/22/2007 3:27:32 AM

Tuesday, May 22, 2007 3:27:32 AM

Post# of 12660
Quite - you've exactly perceived and articulated my underlying meaning in my query - that the reactions and discussions suggest a "Major Deficiency" letter was issued, rather than the "Approvable". And yes, after reading thoroughly all of the FDA's criteria for the various letters, I do indeed think an Approvable bodes well for Provenge. As I said, I think the stark differentiations in criteria between the two types of letters are very illuminating.

I'm anxious (isn't everyone?) for the next few weeks to pass quickly so we can get to the answers - speculation is an exciting exercise in mental masturbation, but not nearly so satisfying as the orgasmic light of truth.

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