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Monday, May 24, 2010 9:50:18 AM
We have hashed many concerns here about does it work, do issues remain. When is the 30-60 days up. Yes I DO think they had issues after submission but as many here have said, the DVIS will always be tweaked and evolved-I feel confident FDA has enough info to render a decision. They have been asking for very minor info from I3 and will Approve it-when? We already know FDA does not care about 30 day response times etc...as such are only guidelines, wether it is minutes, days or weeks away-we are close and approval is coming!
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