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drbio45

05/13/04 3:51 PM

#159 RE: DewDiligence #158

is it 3 months or 6 months?

You ask that question as if someone can answer for the fda

You file an nda, it should take 12 months, you are looking at 15 to 18 months if you are lucky.

It you believe the open bla means nothing you are entitled to your opinion but that is all it is, your opinion. don't speak for the fda because their response time will be shorter.