Zonagen (zona) - good buy? Message Board

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

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To: Bill Wexler who wrote (2061)	1/27/1998 7:30:00 AM
From: F. Jay Abella, III	Read Replies (2) of 7041

Bill: <<<Wow. I'm impressed. Despite the fact that this is pure gobeldygook which completely evades the fact that phentolamine does not produce erections. Debating how fast it is delivered into the bloodstream is a red herring.>>> Good point. When will someone tell us what ZONA found in their company-sponsored PK trials (and not what some researcher found in 1975 or 1981)? Did any of the ZONA phase III protocols have a PK component? If so, why was discussion of the following omitted from the white paper? At what time points did phentolamine produce erections? How much phentolamine did it take to produce this effect? Were the results statistically significant versus placebo? Was there any noted toxicity? Did the drug or any of its metabolites accumulate in patients? Were any of the metabolites found to produce adverse effects? If so, is there a metabolite profile and whendid the AE's occur? These are not difficult questions to answer if there is, as you say, a validated assay available with low limits of detection? Doesn't it trouble you Keith that in the areas of absorption, distribution, metabolism and excretion, we have no answers from ZONA? If data are available from ZONA sponsored studies, could you please post it? If data are not available, do you know if SGP will be allowed to fill the PK section of the NDA with journal articles only? Insights? FJA

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