Darn, just when I was thinking of going long! All of this harkens me back to the previous posts from a 'Zonagen investigator' on the ZONA/MF board last month. Seems like he knew what he was talking about after all:
<<Subject: Investigators Opinion
Date: Thu, Oct 2, 1997 11:37 EDT
From: Ppmd4
Message-id: <19971002153701.LAA04900@ladder01.news.aol.com>
I am a urologist and have been an investigator for the Phase III studies with VasoMax..I have read the postings on this board with a certain detached interest...because although I became aware of ZONA back when it was about $10/share, I did not take a position in the company - not the first, and certainly not the last stupid thing I'll do!
Anyway, I am considering taking a position NOW....but I'll probably remain as indecisive as ever... Here's what I know about VasoMax...
First - this is NOT a very effective drug...among many of the investigators who took part in the earlier Phase III trials, the drug was felt to be virtually ineffective...At our own site, we had 30 patients enroll in the Phase III placebo-controlled trial which took place earlier this year... At the end of the trial, when the subjects were offered the chance to continue on the medication in an "open label" trial extension, virtually none of them were interested. This experience was echoed by virtually every investigator I've spoken to from the study.
Second, the company's original intention was to complete the Phase III trials by the end of April 1997, crunch the data, and submit the NDA by June 1, with the expressed intention of beating Pfizer to the punch...NOW, Zonagen has launched another Phase III trial - and the investigators have been told that this trial was requested by the FDA - not that the company wants the data "just for marketing."
Interestingly, there are several differences about the newest trial. First - it is a "dose escalation" trial - which means that all the patients have the option of increasing their dose level during the course of the study - up to 80 mg- which is twice the dose used in the Phase III trial earlier this year..Second, the new protocol has restricted entry criteria to men with "minimal" erectile dysfunction.. Among the investigators, the joke was that they wanted to only study patients who didn't really need any help to begin with... It seems as if the company has had it's efficacy data questioned by the FDA, and their new Phase III study has been designed to try and produce "better looking" data.
Finally, I think that it may be a mistake to place too much faith in the "Professors" who speak publicly about these drugs... Pradma Nathan is on everyone's payroll - Pfizer, Zona, etc..... he is very unlikely to speak publicly against any of these medications...Personally, I think that there is a chance (maybe 20 - 30%) that this drug will not get FDA approved due to efficacy issues... I think there is even a greater chance that Viagra - which had seemed like it was going to be second out of the gate - may now beat Vasomax to the market....AND - there is absolutely no doubt that it is the better drug.....Vasomax MUST be released first if it is to capture any market share at all....If Viagra comes out first, Vasomax will be an also-ran - and completely out of the money..
So-o-o-o-o-o, if I had a big profit in ZONA, I would probably take it and run....as I said, I am thinking about taking a position - but obviously, I'm thinking about shorting this one !!!
ppmd4>>
<<Subject: Re: Investigators Opinion
Date: Thu, Oct 2, 1997 17:21 EDT
From: Ppmd4
Message-id: <19971002212101.RAA25801@ladder01.news.aol.com>
Wow! What a reaction.. You guys must really be deep into this company.
I assure you... I am a urologist..I am a Vasomax investigator....I HAVE NO POSITION IN ZONA....and I probably won't take one. I agree that, as an investigator, I would be treading on thin ethical ice if I used my knowledge of the trial's results for my own gain... However - I repeat - I have no position in ZONA - and never have....
As far as my misspelling of Dr. Padma Nathan's name....well, outside of academic circles, he is pretty much of a mystery to most community urologists - especially if they are in a different area of the country. Having spent some time in academics, I can tell you that a majority of academic physicians are full of crap.....not to say that there aren't some truly gifted physician/scientists in our University medical centers, but they are few and far between.
I am not an academician....90% of the sites that did the Zonagen 301, 302 and now 303 studies were community-practice based sites.... they were NOT in the academic centers...
Believe me - this drug is marginally effective at best.....but I don't know what standard the FDA will hold the company to....Any urologist will tell you - being able to demonstrate a "statistically significant" difference in the treatment group does not translate into a clinically worthwhile drug - just look at Proscar if you want an example.. Merck submitted wonderful data showing "statistically significant improvement " in the treatment groups, but Proscar is a marginally effective drug, and has been a great dissapointment to Merck..and every urologist will confirm that... As they say, there are three types of liars: Liars, Damn Liars, and Statisticians......
So, I don't know what the future holds for Vasomax... IF they can convince the FDA that their drug is effective, Zonagen will still have to beat Viagra to the market....These drugs are NOT complementary.....patients might respond to Viagra and NOT to Vasomax, but the opposite is not true...it's hard to see how a patient would respond to Vasomax but not to Viagra.. True, they have different pharmacologic actions, but they ultimately work the same way - to increase cavernosal blood flow and trapping.
Anyway, if you doubt the accuracy of my observations, I invite you to e-mail me...I'd be glad to provide you with the names of 6 or 8 of the other investigators from the Zonagen studies
ppmd4>>
Bev, maybe it's time for you to jump on the Vivus short wagon and recover some of your losses!
Bradpalm1 |
