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Re: drbio45 post# 76852

Tuesday, 04/28/2009 9:00:57 PM

Tuesday, April 28, 2009 9:00:57 PM

Post# of 252428
RE: DNDN - "under the best circumstances it will still be under review a year from now"

Uhm, perhaps a calandar can help you out?

Oct resubmission is very reasonable. That means an FDA date in less than a year.

I do agree the CMC section is far from clear.

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