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Biotech / Medical : Biotech Valuation
CRSP 54.94-0.3%11:08 AM EST
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To: semi_infinite who wrote (21247)9/14/2006 7:33:20 PM
From: Miljenko Zuanic  Read Replies (1) of 52153
 
I am not, only about general requirement for API/finnal drug stability before any NDA/SNDA. Stability is done (and has to be bullet proof) before PIII start. it was surprise that this issue emerge during NDA review, which indicate serious problems and sloppy job done by applicant.

Miljenko
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