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Re: None

Friday, 07/02/2010 11:21:16 AM

Friday, July 02, 2010 11:21:16 AM

Post# of 59551
I can smell 90-days just around the corner.

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.