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Biotech / Medical : Zonagen (zona) - good buy?
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To: Dauntless who wrote (5447)9/3/1998 4:48:00 PM
From: Tokyo VD  Read Replies (1) of 7041
 
Dauntless,

It is true that approval times are decreasing, but the FDA has taken many black eyes for approving drugs that appear to have greater safety issues than previously demonstrated in controlled clinical studies.

Your speculation that an FDA decision could be handed down in the 12 month time frame (from submission) is valid, but so is the speculation that the FDA may request more data or take the entire 18 months.

Tokyo
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