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Friday, July 02, 2010 11:21:16 AM
I was wrong about my 60-day analysis, and I apologize. I attribute that to the notion that the new FDA Review Team does not consider the April 5 DViS submission to be a submission in response to a 2nd or Later Information Action Request because they are completely discounting everything that happened under the prior review team. Rather, they are treating the April 5 submission as an initial submission because it was the first submission made to the new review team. Under the FDA's internal guidelines / goals, the FDA endeavors to respond to initial submissions within 90 days of receipt (i.e., July 8). Frankly, I find it obnoxious that the agency ignored the prior submissions for purposes of counting their review time, but I certainly would not put it past them, and it would be easy for them to justify. That being said, April 8 is just 3 trading days away after today and I'm getting that excited feeling again.
Good luck everybody and happy America's Birthday to you.
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