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Ryoko

07/15/10 12:52 PM

#19828 RE: IMGGorBust #19827

I don't mind the wait. But the bleeding is not fun. The bid stack is looking pretty feeble. We may actually taste the 20s again.
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IMGG4TP

07/15/10 12:59 PM

#19829 RE: IMGGorBust #19827

IMGGorBust, I have been reading in past posts that there have been communications with the FDA since the Apr 5 AI submission that have reset the review period clock. I emailed Dean for verification of this, but no response. To your knowledge, is this true and, if so, when and what was the nature of this communication? TIA.
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bcatch

07/15/10 1:11 PM

#19833 RE: IMGGorBust #19827

If the FDA is treating the last submission as a first time response then IMGG is probably not on the fast track program and the clock would have been reset to thier last written request, which was on 4-23. This would put the 90 day time frame at 7-23, the end of next week. For what's it worth, this is also Dr Polks opinion, who seems to be very credible.