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

To: Dauntless who wrote (5196)	8/11/1998 4:36:00 PM
From: Tokyo VD	Read Replies (1) \| Respond to of 7041

Dauntless, You know I agree that accurate information is the best way to assess an investment opportunity, so let's clarify my point and what I read into your statement. You implied that the FDA has been satisfied with the results from Zonagen's clinical studies to date. I say that this assessment has not been made (unfortunately I do not have a "link" to provide to this information at an FDA web site). Make no mistake that the FDA will make a decision on Vasomax after it has examined all clinical data provided by Zonagen in its NDA. My interpretation of your statement was that you suggested that a company wouldn't file its NDA if the FDA were not satisfied with the preliminary reports it received. I say that there are alot of cases where companies believe the data they submit meets the primary endpoint (and demonstrates statistical significance). One such company (that you and another poster have traded barbs on) is Texas Biotech. TXB filed its NDA for Novastan in August, 1997, and received expedited review status from the FDA. The FDA had reviewed the preliminary reports, granted expedited review, but rejected the application (even after asking and receiving supplemental data -- which Wall Street felt strengthened its application). I hope this clarifies my point about your statement. Tokyo