I recently found the following post on the MF/AOL Board:
<<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>>
If this guy is really who he says he is, he's got a lot of guts. My personal knowledge of these studies is not as dire as he suggests.
Make your own judgements.
Bradpalm1 |
