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

To: Linda Kaplan who wrote (3845)	5/3/1998 4:14:00 PM
From: CalculatedRisk	Read Replies (2) \| Respond to of 7041

In Today's paper (5/3/98), from Wall Street Journal reporter Andrea Petersen (Story regarding Viagra): "Zonagen says it plans to apply (for Vasomax) to the FDA for marketing approval within a month or so." Regards, Bill

To: Linda Kaplan who wrote (3845)	5/3/1998 4:28:00 PM
From: Anaxagoras	Read Replies (2) \| Respond to of 7041

Hi Linda; I think there's some confusion You wrote: <<No money on submission to FDA, only on approval by FDA, and only if the filing with FDA is accepted by FDA on time.>> That's not my understanding. There should be a payment triggered ... * after the occurrence of both (i) the completion by Zonagen of the * study of the Licensed Product and the submission of a report to Schering for such study, which reports is in a form reasonably acceptable to Schering and * and ii) the submission to and acceptance by the United States Food and Drug Administration of a New Drug Application for the Licensed Product in the Field; provided, -------- however, that such NDA is accepted for filing on or before *>> In other words, as I believe Hank may have argued, there is to be a payment provided an NDA is submitted and accepted in a timely manner. This is the info in roman numeral ii above; I assume the part in roman i has already been met, but of course there seems to be wiggle room if Scherring should decide at the last moment that the report is not in a reasonably acceptable form. Any clarifications to my thinking are appreciated. Anaxagoras