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Re: ElHefe post# 9030

Friday, 01/15/2010 2:47:01 PM

Friday, January 15, 2010 2:47:01 PM

Post# of 59551
I agree there's no way to put an exact time on it, but I'm sure you understand why it took them so long this time around, don't you? There was a transition from one review team to a new review team, and that transition happened to begin around Thanksgiving, and continue through Christmas, New Years and the biggest snow storm DC has seen in a decade (which shut down the gov't for a few extra days). There was nothing typical about the time period between our last submission to the FDA and their response. We will respond some time in February, I'm hopeful it will be in the first week of February. This time around we will not have a new review team assigned in the interim. We do not have the holiday season. We're not expecting another blizzard in DC. This will be a more typical turn around time, and per Dean, that should be 30 days.