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

To: Steve H. who wrote (3342)	4/8/1998 8:43:00 AM
From: Dauntless	Respond to of 7041

Steve H. & Hank Steve - I don't have any specific knowledge of the milestones. In my post I listed events that I THOUGHT would normally be considered to mark significant, measurable progress. In my experience, I've often seen fundings, bonuses, etc. tied to exactly these events. Others could be: - reaching certain cumulative sales levels - approval in certain geographies outside the U.S. Hank, I found & read the FDA information & pretty much agree with Steve's comments. The info provided specifically applies to the design of clinical trials - it does not discuss approval criteria. I am still looking for a reference that identifies anything other than safety & efficacy as the considerations for approval - please provide one if you can. Maybe this is an "unwritten rule" - but when the agency leaves things unspecified it's usually not an oversight - it's so they aren't painted into a corner. Obviously, there's a lower limit - efficacy in 2% of patients probably wouldn't get approved. Vasomax's 30% - 40% efficacy is clearly not spectacular, but it is a reasonable chunk of the patient base. I just can't see the agency creating a situation where guys who are not helped by Viagra, or can't tolerate it, have to jump to Muse or Caverject. I'm not slamming those therapies (some day I may be glad they're around) - but I'm sure I'd try every oral medication available before going invasive. This is a well understood, relatively safe compound with reasonable clinical trial results. With only one oral alternative I don't see it being rejected simply because it doesn't have the same efficacy as Viagra. All IMHO.