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Biotech / Medical : Agouron Pharmaceuticals (AGPH) -- Ignore unavailable to you. Want to Upgrade?

To: Tom DuBois who wrote (4269)	5/7/1998 5:35:00 PM
From: biodoc	Read Replies (1) \| Respond to of 6136

Believe it or not, such trials are sometimes not done with as much rigor as supposed, there have even been (rare) cases of fraud, but often there have been cases of poorly done marginal trials. Sometimes to find this it takes a full audit of all the clinical sites, which takes a long time. In addition, the manufacturing to GMP standards must be audited etc. usually the FDA will completely reanalyze the trial, (and sometimes the results don't agree with the sponsor's analysis). Two years, however, is on the long side for important (from a public health point of view) new drugs these days. In fact, if the review is fast tracked, it can take 6 mos or less.

To: Tom DuBois who wrote (4269)	5/8/1998 11:25:00 AM
From: tommysdad	Read Replies (1) \| Respond to 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.