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Biotech / Medical : VVUS: VIVUS INC. (NASDAQ) -- Ignore unavailable to you. Want to Upgrade?

To: MissLil who wrote (4175)	1/1/1998 3:58:00 PM
From: Zebra 365	Read Replies (1) \| Respond to of 23519

I think we need to look at why "studies" like this are coming out now. This has nothing to do with Pfizer and Viagra first of all. You have to remember that the injection is the only effective treatment now available in Europe. Judging by what MUSE has done to the market for injectible treatments in the US, I assume these are shots across the bow from the friedly folks who sell injectible Alprostadil in Europe. Of course the Caverject and trimix are used in the US still also, but you would just have to see the expression on the faces of the men when you first tell them about self injection. And I thought getting diabetic patients to inject insulin was difficult!! I imagine that many of the men using self-injection now are diabetics on insulin who are used to self-injection as a treatment. So the only thing that the injection has over MUSE is efficacy, a point I readily conceed. As MUSE prepares to enter the European market, we can expect more such studies, like Dr. Greco's, to surface in order to try to retain market share for the injectables. Super Efficacy will be stressed as the 1 kg test demonstrates a higher degree of efficacy (over what is needed for clinical efficacy). As I mentioned in my previous post, I think the stock action we saw yesterday was a few nervous shorts starting to jump the gun. I'm buying 1,000 shares at open in the AM for a day trade, unless it already gaps up too much. As of today, this stock now has a 12 month trailing P/E of about 10. A Firm and Happy New Year to All Zebra

To: MissLil who wrote (4175)	1/1/1998 10:24:00 PM
From: Cacaito	Read Replies (2) \| Respond to of 23519

MissLil, the study is not for the FDA, Muse is already approved. Double blind is not strictly necessary, it is more difficult and more expensive to do, the researchers probably were in a hurry and short of money. It is not exponsure by Vivus, maybe not even from other pharma. It is a post marketing study looking at a population that is not the initial aim group for Muse , this is the severe ED patient that needs injection therapy. It is a small view of what this researchers (independent?) are seeing in the real clinical world. Double blind not necessary because the patients were all known to be responders to the injection treatment, and Muse efficacy in ED is known. Or are you going to subject the patients to an intraurethral placebo? To stick something in your penis that does not work, when ther is something known that it works? Not ethically appropriate, and one of the reasons the FDA is very tough before approval, one something is out that works it is very difficult not to give it to the patient and use placebo. It could be done, but most more difficult. If you look at the Muse use results it was almost 2/3 lower than injection (not unexpected). The injection use is one of the approved and common forms of treatment. Self-reporting is a very common technique of evaluating many clinical situations and sometimes the only way of getting information in an ethical way, What are they going to do? Video patients and partners? contract patients and surrogated partners? If they use highly "objective" test like: buckling test, blood flow measurements , penile gauges, How will they correlate the results with the real sex life of patients? Self-reporting could be probably closer to real life than many of the objective tests. Besides there are ways of decreasing the chances of lies and inconsistencies from the subjects (usually most subjects are honest). The study is good in what it was looking for: responders to Muse in a gorup of ED patients on injection therapy. The Muse/prazosin combination studies most be highly rigorous studies, and this are in plans. or ongoing?