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Biotech / Medical : GZTC
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To: Meridian who wrote (398)9/25/1997 7:52:00 PM
From: Steve Push   of 752
 
The AT III trials have progressed quickly because the transgenic AT III is very similar to the tissue-derived AT III. Under current FDA rules, there are no generic biologics, and all transgenic biologics will have to go through clinical trials. How many trials depends on many factors, and no blanket statement can be made for all future transgenic products. It is unclear whether transgenic products that might be classified as drugs (as opposed to biologics) will be required to undergo clinical trials or be eligible for generic status.
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