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

To: Tokyo VD who wrote (2578)	2/27/1998 10:00:00 AM
From: Diamondcutter	Read Replies (1) \| Respond to of 7041

How would any company know what the optimal dosage rate is for a drug without trying several levels and comparing results versus side effects? Given that this type of drug (ZONA, VVUS, PFE etc) will be used in "passionate moments", there is the risk that some guy will use more than the recommended dosage to "ensure" a positive reaction. Naturally, the FDA and the company will want to test different levels for adverse effects. Diamondcutter

To: Tokyo VD who wrote (2578)	2/28/1998 12:37:00 AM
From: Bruce Rosen	Respond to of 7041

<<Oh, by the way, you said that only the 40 mg dose is being used in the open label trials. THIS IS A LIE (intentionally or unintentionally). The two doses offered to patients are 40 mg and 80 mg.>> I have been told, by people I believe are in a better position than you are to know the truth, that only the 40 mg dose is currently being used and that only the 40 mg dose will be submitted to the FDA for approval. If I am wrong, I assure you it would not have been intentional. I will attempt to confirm my facts on this and communicate what I find on this fine board. <<My question for you is why did Zonagen report a success rate for the 80 mg dose (it was 48%) in the Phase III study that dispensed the 80 mg dose as a safety measure? >> Perhaps to show that there is not a large increase in efficacy between 40 mg and 80 mg, which would lessen the motivation for someone to take the larger than prescribed dosage.