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chevyman

12/10/10 11:20 AM

#33788 RE: IMGG4TP #33787

macho, just for the sake of argument, do you send in extra money when you file your taxes, just to be sure your covered? I don't understand why the complexity of this is not clear to everyone? Dean felt he gave enough info, yet it wasn't enough, and the NSE appeared more of an AI letter, so they want to be sure!
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BuyOnDips

12/10/10 11:24 AM

#33789 RE: IMGG4TP #33787

I agree. Dean is not perfect, but he is human. It appears that Dean is doing everything possible to prevent making the same error twice. Dr. Cohen held positions in upper management at the FDA. There is no doubt in my mind that he knows exactly how the inside operations of the FDA work. I also believe that he will be at the meeting with the FDA prior to submission to insure they have everything the reviewer will need.