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Biotech / Medical : Zonagen (zona) - good buy? -- Ignore unavailable to you. Want to Upgrade?

To: Brander who wrote (5443)	9/3/1998 10:50:00 AM
From: biodoc	Respond to of 7041

I believe you are correct. They will not issue a refusal-to-file soley on the results of the efficacy trials unless there is a clear deficiency in the design or a blatant lack of efficacy data-- i.e., something the agency asked for previously and they didn't do, etc. etc. While I don't think the drug will ultimately be appproved, I'm not counting on an RFT letter. More likely causes of a refusal to file would be something in manufacturing such as validation issues or process issues. My guess is that fixing some issue like that is what was really behind the SG induced delay in filing. So, I think Linda has it right---look for drifting down, but unload the Sept. puts before the 60 days is up.