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stockmasterflash

01/10/11 3:39 PM

#34806 RE: mr_sano #34805

That's usually the case when the FDA makes a final determination

Minor issues are resolved with less formal correspondence

A decision letter is sent when the company can't or won't resolve discrepancies
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Lockedon6

01/10/11 3:40 PM

#34807 RE: mr_sano #34805

The most important ? the code (s)?
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Denunzio36

01/10/11 3:45 PM

#34808 RE: mr_sano #34805

Sano - Can you at least give us the jist of it beofre you upload? Can you tell us if the long list of issues were major issues? Or was it mostly admisinstative issues like Dean had stated? Thanks for doing this DD...much appreciated