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pendragon8062

07/22/10 9:35 AM

#20829 RE: BigOwl47 #20828

I've been holding off from posting this since there's been so much drama, but when I e-mailed Mike about the re-submitted package, this is what I recieved

"What Dean sent the FDA was on his own initiative not at the request of the FDA for a formal resubmission like we had to do for the new review team in April. My understanding – and if my understanding is off-base in any way I’ll let you know – is that Dean annotated the document so that the reviewer could connect the dots faster. The prior review team had asked for some non-standard things (for lack of a better phrase) and these requests from Team #1 complicated things for Team #2. It was just easier for Dean to expand the table of contents with more specific information and then tag those sections in the document. This would be best accomplished by simply giving them another copy of the full document with annotations and other explanatory text to help this reviewer understand the structure of the document which has become very large"
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Chemic76spirit

07/22/10 10:27 AM

#20842 RE: BigOwl47 #20828

One would think that with four prior successful FDA approvals that Dean would know what system the FDA uses and if they would have been able "to open" the files they needed to, what format etc... Especially after all those phone CC's he had, and bla bla bla bla bla. The fact is Dean screwed up and he {under cover of silence to the awaiting shareholders} had to resubmit the entire package or else be disgraced and humiliated totaly, and possibly beyond repair! I believe he pulled it off. Nice one Dean. None the less this showed us {He can not be trusted}; all of his transparency of the past went right out the window in one fell swoop. I am still holding, ONLY because I can't afford to leave now. Just wanted to say THANKS DEAN for covering your hind end, and hopefully mine too.