Agouron Pharmaceuticals (AGPH) Message Board

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Biotech / Medical : Agouron Pharmaceuticals (AGPH)

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To: Tom DuBois who wrote (4269)	5/8/1998 11:25:00 AM
From: tommysdad	Read Replies (1) of 6136

What you are missing is simply never having seen an NDA submission. It is a sight to behold. A typical NDA is simply gargantuan in size -- we're talking multiple boxes of file folders. The minutiae that are often included are staggering. Down to "what was the commercial supplier of the solvents used to clean the glassware"? "What were the mice fed"? Etc. Etc. It takes dozens of people months to put together and is the culmination of years of work -- so, yeah, it will take the FDA a while to sort through all that stuff. It isn't simply "Is the drug safe and effective" but also "Can they make it routinely on a large scale with adequate controls" and "How long will a pill last on a shelf in a pharmacy before going bad", etc. etc.

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