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 (6742)	5/12/1999 6:32:00 PM
From: VLAD	Respond to of 7041

Claud, Face it. You are in DEEP DOO DOO with your ZONA. Day trading and short covering has given ZONA a nice pop from 8 3/4 to 15 1/4 over the last 3 trading days. But mark my words, when the volume tames down starting tomorrow nobody will support this stock because it ain't worth much more than book value with current fundamentals. VLAD PS I got a good laugh studying the history of this company. The initial hype over a sterilization vaccine was such a crock of s### that I couldn't stop laughing. Even if such a vaccine were perfected it wouldn't stop female dogs from going into heat and spotting on the pet owners floor etc. Nor would it change the high incidence of mammary adenocarcinomas or pyometrias that can only be truely preventing via early spaying. I don't know what kind of "scientist" could even think that such a vacine would be a block buster product. Even a first year veterinary student could tell you what I just explained. I also was apauled by the 2 articles I read from the Houston Chronicle--it certainly gives Bill Wexler's claims a lot of credibility. IMHO the Vasoscam story is no better than the pet sterilization concept. It is hype and bad science--nothing more. The part that I really don't understand is that SGP ever involved itself with the product. I think that they made some assumptions about Vasoscam that didn't pan out--starting that efficacy wasn't that important so long as they had an oral ED pill to represent in the market. The FDA may have allowed Pfizer to get away with murder on Viagra but evidently they won't budge on neither efficacy nor safety issues concerning Vasomax. SGP made a HUGE mistake on Vasomax but the money invested thus far is peanuts on a relative scale for a big pharmaceutical company.

To: Claud B who wrote (6742)	5/12/1999 7:47:00 PM
From: Tokyo VD	Read Replies (2) \| Respond to of 7041

Claud, Unfortunately, you are wrong. The FDA does not reject drugs outright. They issue non-approvable letters. The reason they issue non-approvable letters is that the data submitted by the drug company doesn't meet the safety and efficacy standards established by the FDA. A drug company amend an NDA with new studies that demonstrate outcomes that are different than the previously submitted NDA package, but that takes time and coordination. IF Zonagen/Schering have undertaken such studies, then Zonagen/Schering had obviously concluded that the feedback they were receiving from the FDA regarding their NDA was not favorable. This unfavorable feedback leads the FDA to invite Zonagen/Schering to attend a panel meeting of sub-specialty experts (urologists). This panel would hear the reasons why FDA statisticians and investigators believe the drug did not achieve safety and efficacy marks that warrant approval. Zonagen/Schering would be asked to present their position in defense of the data that it submitted. Zonagen/Schering chose not to defend the application. Therefore, the FDA has no choice but to issue a non-approvable letter based on the data submitted. The FDA does not issue non-approvable letters based on a drug company's decision not to defend its application. Tokyo

To: Claud B who wrote (6742)	5/12/1999 8:37:00 PM
From: Dr. Voodoo	Respond to of 7041

Claud, Tokyo is right. The NDA process isn't like sending off boxtops for Cracker Jack toys. No offense meant. The FDA is in regular communication with the people who file. I don't believe the 'marketing' decision line. This is just not even remotely believable. I just can't believe if you're a doc your going to be looking at 'a few percent efficacy closer to viagra' before you write a script for vasomax. Furthermore, Joe P. said in the conference call that he expected the non-approvable letter by the end of the week. Think about this. They likely submitted THOUSANDS of pieces of data to the FDA. If the FDA had not reviewed this carefully and found it not sufficient, they would not be able to put together this letter. Next, SGP and Zona felt going before the panel would be a waste of their own time. What the heck does attending a one day panel cost SGP? There is no amount of mathematics that I know of that says getting a better label out of this deal gets anybody more money in the long haul. Sorry Joe P. I don't believe your story. You'll have to convince me otherwise. Waiting for options expiry and the non-approvable letter to arrive to short, hopefully I can get some shares at a price somewhere above 0. Just my opinions Claud, no offenses meant. V

To: Claud B who wrote (6742)	5/13/1999 12:11:00 AM
From: VLAD	Read Replies (1) \| Respond to of 7041

Claude, <<Neither Zonagen nor Schering-Plough would release the results of the tests that prompted the delay in the drug application.>> This is a quote from the AP press release on May 11. Can you please explain to us WHY we can't be informed of the results of the tests that prompted the one year delay in the drug application? We just want to see the hard science and facts on Vasomax. What has been going on for the past two years that requires another year to rectify itself? What does Zonagen have to lose by informing the investors with the hard cold facts? Aren't they required by SEC regulations to reveal information of such significance to the investing public? Isn't Zonagen a publically traded company?