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nybuild1

09/06/10 5:55 PM

#25676 RE: Frank39 #25675

uh oh..... now there goes the wrench to screw everything up....
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ltt05

09/06/10 6:00 PM

#25677 RE: Frank39 #25675

Review time and approval time are very different. Our approval time is 3+ years. Our review time since the last submission is now at 150 days, which is the time frame for the FDA's goal to issue a response.