Zonagen (zona) - good buy? Message Board

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Biotech / Medical : Zonagen (zona) - good buy?

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To: Skywatcher who wrote (1314)	12/24/1997 10:02:00 PM
From: Dauntless	Read Replies (3) of 7041

Chris & thread The subject of the delay in filing of the NDA has some people upset so I thought this might help. Zona was originally predicting the filing to occur in the 2nd quarter of 97. Contrary to what many believe, the FDA is actually quite willing to meet with companies before & during the conduct of clinical trials. They will often suggest that certain studies are or are not necessary. Zona had consistently been told that a certain study (in mice) for carcinogenicity would not be required because they felt that the action of phentolamine was well understood in that area. When the clinical trials were complete (or very nearly complete) the agency suddenly did an about-face & told them the study would be required. No one was worried about the outcome - but the trial required a 6 month incubation period - no way to shortcut that time. So instead of doing the study in parallel earlier, it had to be done after everything else was finished. Minimum six month delay from original projection. Thought someone would like to know

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