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Re: BennyJ post# 13947

Wednesday, 04/21/2010 2:32:23 PM

Wednesday, April 21, 2010 2:32:23 PM

Post# of 59551
Benny - If we do not hear approval on or before May 12 then we can assume that an extension was filed again. I posted this on April 6th Post # 12988.

The Fda receives two methods of re-submission. One goes electronically the other is hard copy by mail. The posting by the FDA generally takes up to 4 business days. We are then up to April 9th. At that point the FDA will respond in 30 Days from the April 9th date. This will bring up to May 9th.

Keep in mind that because the "New Team" at the FDA has us on the Fast Track and we can communicate by phone it should go a bit quicker. It is my belief that Dean feels comfortable enough with the new review team and he said on MTV that he will attempt to contact the reviewer about a week or so after this submission.

All this said it is my bet that we will hear from the FDA and or Dean prior to May 9th. My gut is telling me April 23rd. Hope for the best.

The reason I said May 12th is because after the 30 days of silence the FDA will mail it to I3 and it could take 1-2 days.


GLTA