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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?


To: semi_infinite who wrote (21247)9/14/2006 7:33:20 PM
From: Miljenko Zuanic  Read Replies (1) | Respond to 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