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

To: Linda Kaplan who wrote (5913)	10/24/1998 8:02:00 AM
From: biodoc	Read Replies (1) \| Respond to of 7041

Equivalence is ok. The concern expressed by the panel in the example you provided was that equivalence was not demonstrated for safety because the control arm using heparin was at a greater dose than is currently used in clinical practice. Also, the panel advised rejection but the Agency has not ruled. There was one recent example (I unfortunately forget what drug) in which the Agency approved it in the face of a panel rejection, and I think, but am not sure, it could have been this panel. I am sure that Zona would try to differentiate Vasomax with respect to the patient population--i.e., claim it is ok in the patients who can't take Viagra, in order to get around a failure to reach equivalence. In addition, since there was not a head to head comparison with Viagra, any comparison of Vasomax to Viagra is suspect. They don't have to show superiority to the licensed drug to get approved--only that it is safe and effective. Anyone reading this should be aware I have a large short position in Zona.