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DewmBoom

10/27/18 10:48 AM

#155931 RE: Alley-oop #155930

He is talking there about the absolute time and not the FDA count. The FDA clears most applications within 90 days or 100 days, otherwise they will inform the applicants in writing why it has not been approved.

So, an application may take 180 days in absolute time, but in reality it could take less than 90 days in FDA count. In this case here, we know that the FDA had requested Additional Information and BIEL addressed them, extending the clock by several weeks from the absolute 90 day target. That is why the target moved from October 10 to November 2nd, but it is still within the 90 target, by FDA count.

In the original approval of the Actipatch, the process took well over a year to be approved. It was something completely new for FDA and BIEL. During the approval process, the FDA had lots of questions and several meetings with the FDA to reach the approval point. The irony is that they spent almost 5 months or so discussing and analyzing real world back pain data at that time.