Thursday, December 30, 2004 12:03:07 PM
The first draft was over a year ago, a couple of deadlines have passed for it's release and now it looks ready to go.
"The widely anticipated document....."
Hmmm....widely?
Who do you suppose is waiting for it (outside of DNAP investors that is)?
I wonder who has been driving this document with the FDA, who do you suppose has the clout to demand guidance from the FDA?
Who has reams and reams of data from their thousands of drug trials, even the 'failed' trials that could be resurrected if classifiers could be considered?
Why do you suppose the document has had to be rewritten so many times over the last year?
Perhaps it needed to be adjusted in order to accomodate all of the classifiers waiting in the wings. It is doubtful that a "guidance" document from the FDA would be "widely anticipated" if there weren't a number of products waiting on it's release.
regards,
frog
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