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IMGGorBust

07/16/10 11:17 AM

#19954 RE: BuyOnDips #19952

I understand he sent it to them on July 5, which means they were communicating closely in early July. That's why I think the FDA was really trying to get it all done within their 90-day review period but just couldn't figure out where the new pages Dean had sent them in late April fit into the overall application. Rather than trying to walk them through it all again and again, Dean just re-sent them the full package with the couple of minor changes in their proper place. This was not a new package or a new submission, or a response to new questions or anything new at all, it was just resending the same package as a whole, with the couple of changes requested in late April put into their proper place rather than standing alone.