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


To: Dauntless who wrote (1355)12/26/1997 4:59:00 PM
From: Michael Bidder  Respond to of 7041
 
Oh! now I understand.



To: Dauntless who wrote (1355)12/26/1997 5:07:00 PM
From: Bill Wexler  Read Replies (1) | Respond to of 7041
 
This un-armed man now has your money.

Phentolamine is an ancient generic medication which has proven ineffective when used alone in the treatment of ED. It is sometimes used in combination with other drugs and injected directly - however the FDA has not approved it for this purpose.

Since it is well established that phentolamine does not work for ED when injected by itself directly into the penis, it seems highly unlikely that the FDA will approve a systemic solution (i.e. a magic pill). I would put the odds of rejection at say...ohhh...100%. but this is a moot point, since I seriously doubt that Zonagen will submit an NDA. Maybe in the meantime thay can give us all another laugh by re-announcing their phony stock buyback.

Zonagen has indeed obfuscated the trial results. First of all the experiments themselves (particularly the German trials) were poorly designed, and the results of their poorly designed experiments still show no statistically significant proof (when compared to placebo) that phentolamine mesylate works. End of story.

Zonagen is a fraud and will soon trade in the gutter. You can insult me all you wish and keep making lame accusations that I work for "Asholio" but this will not change the fact that Zonagen is a worthless shell and a classic "pump and dump" scam stock.



To: Dauntless who wrote (1355)12/27/1997 11:24:00 AM
From: Tokyo VD  Read Replies (1) | Respond to of 7041
 
Dauntless,

What is the name of the drug or the product on the market for ED, in France, today, that is another alpha blocker?

Tokyo



To: Dauntless who wrote (1355)12/28/1997 1:23:00 AM
From: Cacaito  Respond to of 7041
 
Dauntless: The Original Zorgniotti article the patent is based on is very clear:

"Emphasis was placed on the requirements to have coitus and not to expect spontaneous erections without this."

I have the full article from the Int. journal of Impotence Research (1994). It is clear sexual stimulation was required, as the subsequent works from Zonagen also did. Just a clarification, not big deal.

Bioavailability of the drug is less than 20% from the gastrointestinal mucosa no matter how fast one disolves Phentolamine mesylate (it is still the same compound). Probably this does not matter, the dose they have chosen is based in part in safety issues.

Phentolamine and viagra both work better in neurogenic problems which have normal vascular bed in the penis, like in complete spinal trauma.
The more vascular problems the least chances it will be effective.

FDA will not approved it just for psychogenic ED, it is not necessary and viagra will work well in those cases. It must be effective and safe in organic ED, and that is the aim of the company.

The carcinogenic rat extra study was probably a company error now explained as an "FDA change of mind".

The company is explaining the extra 2,000 patient long term safety study as better for "the least restrictive use approval", probably the FDA actually required then to go that way because of high safety concerns and lack of data. Just more delay.

Bruce, Von Elmster is just "holding", was he buying at $40?

Dauntless, please provide the name of the drug approved in France.

Viagra will not be the cheaper one, vasomax will be. This does not matter a lot except for some market pressure on viagra.

The company talk about mexican sales early during the year as something soon (read the IBD article on Zonagen again), and this never happened, I strongly doubt they will be able to sell out of the US without FDA approval. Not even in Mexico lax system.

The Slide show does not provide with anything that could amount to any prove, just a small peek into the Zonagen trials. But they do have some reference to the type I study (Becker et al, J of U, 1997) I will look for it, sample is small as usual for a type I, if this is from Zonagen original type I, it is very important to look at it. Very strange it is not in the news that it came to a journal (if it did).

Maybe they can do like ABTI and buy some small company with real research since the pipeline is just full of preclinical projects (and none a good one).






To: Dauntless who wrote (1355)12/28/1997 5:11:00 AM
From: Bill Wexler  Read Replies (3) | Respond to of 7041
 
<<Zonagen's first patent indeed does not hold much hope for Phentolamine as an oral medication to treat ED.>>

This raises an interesting question: then why did Zonagen make such a big deal about the first patent?

<<All of the work detailed in that first patent, however, considered Phentolamine WITHOUT sexual stimulation. When Phentolamine is given IN ADEQUATE DOSES and combined with sexual stimulation IT WORKS.>>

Honey, why don't you just keep doing your thing while I overdose on some Vasomax? By the way, do you know CPR?

<< A standard tablet takes about 30 minutes to dissolve in the stomach, releasing its drug load slowly & never reaching therapeutic levels in the blood>>

Here's a question a confused investor may ask: what sort of tablets did the men in all the clinical studies receive?

<<Zonagen has developed a fast dissolving tablet (less than one minute) that "overwhelms" the liver & provide therapeutic blood levels.>>

Yeah. This is what the second patent is all about. What Zonagen fails to mentione is that this snazzy "new" formulation is actually a very general formulation for a quick dissolve pill. Nothing new. nothing special. Zero.

<<The end result is a convenient tablet that provides natural erectile function provided sexual stimulation occurs, and allows normal sexual activity>>

This is a complete lie. There is zero evidence to support this statement.

<<All with no injections or serious side effects.>>

I agree with the "no injections" part. As far as "serious side effects" are concerned, it's one thing to die while making love, it's another thing to die from a heart attack after taking a bogus erection pill which didn't even help you get to first base.

<<Company information released to date has not "obfuscated" (how would you determine what is obfuscated anyway)>>

Yes...it has been obfuscated and investors have been misled. The way I determined that the results were obfuscated was because the company loudly touted the supposedly positive response to the drug while suppressing the fact that the tests themselves were poorly set up and executed. In light of this fact, it was impossible for the average investor to properly evaluate the drug's potential. This created the necessary "information vacuum" that the touts and shills used to fuel speculation and artificially inflate the price of the stock.

<<This drug will not work for all classes of ED. It will work in about 40 - 50% of the men who have a vascular cause for their ED - that's been estimated at 70-80% of all those with the disease. Oral medications will be the first to be prescribed by any thinking MD. >>

This drug will not work...period. And you don't have a clue
about what a thinking MD would or wouldn't prescribe.

<<For an estimate of what 5% market share means to Zonagen, find my recent post to taxikid.>>

For an estimate of what 0% market share means to Zonagen, find a recent chart of Zonagen's stock price.

<<These are the kinds of facts that Schering Plough bought into>>

LOL!!! Yeah...and look at the "facts" J.P. Morgan bought into when they got involved in Bre-x!!!

<<Of course, you have more experience & knowledge in pharmaceuticals than Schering - so we should listen to you. >>

I certainly don't have more experience & knowledge in pharmaceuticals than Schering. However, I have years of experience in uncovering stock frauds. I can assure you that the victims of these scams range from widows and orphans all the way up to huge corporations like Schering.

Give my warmest regards to Joe Podolski.