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Biotech / Medical : Agouron Pharmaceuticals (AGPH)

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To: Tom DuBois who wrote (4269)5/7/1998 5:35:00 PM
From: biodoc  Read Replies (1) 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.
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