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Re: IMGGorBust post# 14773

Wednesday, 05/05/2010 8:17:58 AM

Wednesday, May 05, 2010 8:17:58 AM

Post# of 59551
According to an email that I recieved from Mike Nessen, the 30 day FDA time frame does not include "administrative days" These can amount to 5 days on both the front end and the back end of the review period. Mike said that in his experience the FDA has always taken these extra days in their response. So, that would make the total number of days 40 and not 30. What I'm not sure of is whether or not they are business days or calendar days. If they are business days, we'd be looking at May 31 for approval. If calendar days, May 15th.

Imaging 3 is apparently very happy with this new review team. In Mike's words "Dean gives this team an A+". I'm very confident that approval will come this time around, but it may be at the end of the month rather than the middle. There is always a chance, however, that the response comes earlier, it's just been unprecedented thus far.