Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

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

To: Claud B who wrote (6385)	4/12/1999 3:07:00 PM
From: Diamondcutter	Read Replies (2) \| Respond to of 7041

An edited (wouldn't want to run into any copyright issues, would we?) clip of the OpCo report that was distributed TODAY is below. Also, if Geller met with the company on April 6th, I would bet that major owners/customers of OpCo knew his conclusions well before today. Diamondcutter In the U.S., Zonagen filed NDA last July, assuring a July 1999 PDUFA date. Schering and Zonagen have had ongoing communication with the FDA since then. We feel that, given Viagra's safety profile, the agency will most likely call for a panel meeting to discuss Vasomax. We believe the companies have already completed further or additional drug interaction and special population studies that we expect the FDA to consider in its review of the drug (i.e. in patients taking nitrates). We believe these trials were successful. The FDA urology panel meets in June and September. A September panel date is more realistic than June to ensure full data submission. We believe the safety profile of Vasomax compares favorably to Viagra and the panel meeting will be positive. Approval should occur within 90 days of the PDUFA date, sometime in 4Q99.