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

To: Bruce Rosen who wrote (1113)	12/19/1997 7:47:00 AM
From: CMason	Read Replies (2) \| Respond to of 7041

Bruce -- What would be the basis for FDA granting expedited review? My experience is that this is generally (although not exclusively) reserved for compounds indicated for life-threatening disease states. That wouldn't seem to apply here. Your thoughts would be appreciated. Thanks, CMason

To: Bruce Rosen who wrote (1113)	12/21/1997 12:07:00 PM
From: BigKNY3	Respond to of 7041

Bruce: <<Maybe not. If Zonagen and Schering can file the NDA in the first quarter, they might also get expedited review. Your scenario may be right, but it is not a certainty. The differrnce in approval time could be six months or less, depending on a myriad of factors.>> Bruce: I think the key words in your statement are "can" and "might". Schering needs to file within four months and then the FDA would consider an expedited review. There is no guarantee that the FDA will provide a priority review even if the NDA deadline is met. Only time will tell. BigKNY3