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Re: colincop post# 33544

Wednesday, 12/07/2016 12:25:05 PM

Wednesday, December 07, 2016 12:25:05 PM

Post# of 54983
Yes, that seems correct. However, the important point is that the 360 day window for a decision starts when the application is officially accepted by the FDA, not when the application was submitted by the company.

A subtle difference perhaps, but important to know if you are looking for the latest time an FDA decision will be reached. So by my reckoning, March 25, 2017 is the latest date FDA has to make their decision. (Of course, FDA can likely delay this if they want - lol)
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