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Biotech / Medical : Lidak Pharm. [LDAKA]
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To: Henry Volquardsen who wrote (588)9/11/1997 5:03:00 PM
From: Linda Kaplan   of 1115
 
Hank, Doesn't the FDA have to respond within a specified time frame? I know that for GENZL, which did have an accelerated proceedure, because it was a product already in use, the FDA had certain specified dates in which they had to respond. Of course, they can respond requesting more studies. They don't have to respond with approval. Maybe only the accelerated process has specified time frames for response, but I'd be surprised if there were none for the normal process. Linda
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