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


To: VLAD who wrote (6590)5/10/1999 4:07:00 PM
From: Linda Kaplan  Read Replies (2) | Respond to of 7041
 
Vlad: I was interrupted too often and haven't listened to the call as yet. I will look forward to it tonight. Drifting down is how I see it, too. No credibility to the company now, even their hype, but I'll probably have more to say after I listen to the call. Meanwhile here's the latest news item:

Headline: (UPDATE) Zonagen Shares Tumble As Review Of Impotence Drug Is Put On
Hold

======================================================================
THE WOODLANDS, Texas -(Dow Jones)- Shares of Zonagen Inc. plunged
Monday after the company said its experimental impotence drug Vasomax
won't be reviewed by a Food and Drug Administration advisory panel next
month, as had been planned.
In late-afternoon trading, shares of Zonagen (ZONA) were down $9.063,
or 46%, at $10.75 on volume of 4.2 million.
If eventually approved by the FDA, Vasomax would compete with Pfizer
Inc.'s Viagra. Industry analysts have said safety data from trials of
Vasomax trials were good, but indicated Viagra is seen as more potent.
The experts don't expect Vasomax, if approved, to reach the blockbuster
status that Viagra has attained.
Zonagen and Schering-Plough Inc., which would market Vasomax, said
they have agreed to forego the planned June review by the FDA panel
until Schering-Plough (SGP) submits additional clinial studies. Zonagen
expects to submit the data as an amendment to the new drug application.
The companies are "committed to obtaining approval of Vasomax with the
optimal safety and efficacy product profile."
As a result of the companies' decision to forgo the panel review,
Zonagen said it expects the FDA will issue a "non-approvable" letter for
Vasomex's new drug application, as currently filed. The company said it
expects that additional data from Schering-Plough's studies will
"enhance the regulatory filing and the commercial product profile for
Vasomex."
Schering-Plough is continuing to seek regulatory approvals for
Vasomax in other countries, having launched the drug in Mexico last June
and in Brazil last month. A regulatory application was filed in the
United Kingdom in August 1998 as the first step for approval in the
European Union.
Copyright (c) 1999 Dow Jones & Company, Inc.
All Rights Reserved.



To: VLAD who wrote (6590)5/10/1999 4:07:00 PM
From: biodoc  Read Replies (2) | Respond to of 7041
 
I too just finished the cc. The approach is to try to spin a non-approvable letter into a marketing decision to submit more data and get a better label a year later. This is just crap. The drug couldn't be approved with the data they have and they know it.

Also, some wording in a description of the 69% efficacy open label trial suggested that it was 69% efficacious in men who stayed on the drug long term. -- Well, it would be very important to know how many men DIDN't stay on long term in that trial because it didn't work or because of side effects. In other words, is the 69% figure an intent-to-treat result, or is it the result in a population enriched with responders (no pun intended).

I bought my puts and will buy more if there is a bounce.

Biodoc



To: VLAD who wrote (6590)5/10/1999 4:50:00 PM
From: Cacaito  Read Replies (2) | Respond to of 7041
 
Zona's cash $40 M? No debt. Joe P is smart. He won't care stock price.

Either they will compensate the executives nicely till the money is gone.

Or they could shop around for small biotechs cash starve, for licensing or outright buyouts.

Farfetched? Not so, Joe P got to this point doing just that, He never dream to hit so good with Phantolamine.

Zona the stock is going to $1, even with the $3 per share as cash in hand.

But the company could survive if they have half a brain. Too much cheap biotechs around. JoeP go an buyout NTII, they need cash. If you are not too greedy you could have real drugs in your pipeline.

I will not be surprise if it becomes E-zona.net.com or something like that. JoeP go, only you could turn a biotech into an internut.

JoeP you survive the first lawsuits and Asensio's first round, You could go ahead and survive the 2nd coming.

Joe P could even try merging with Vivus. He has more brains and more cool than Vivus entire board.