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

To: Jman who wrote (6808)	4/10/1998 2:14:00 PM
From: VLAD	Read Replies (1) \| Respond to of 23519

TO ALL VIVITES, I just got off the phone with the nurse at the largest urology center in my area (seven doctors). Here is a list of some of the Q and A. VLAD: Can you tell me if you have had any feedback on Viagra over the past few days? Nurse: No, it just came out 1 or 2 days ago however we were involved in the original Pfizer clinical studies. VLAD: What did your own study segment show? Nurse: We had a 65% success rate across the board and a 30% success rate from placebo. VLAD: Of that 65% that was helped how many had moderate to severe organic ED? Nurse: The moderate to severe cases were not isolated in the study. The study included all forms of ED including psychogenic and idiopathic. VLAD: Does your clinic use MUSE? Nurse: Yes we do. VLAD: What is your opinion of MUSE? Nurse: Why have a good number of satisfied customers. VLAD: What percentage of your ED cases responded well to MUSE? Nurse: I would say at least 1/2. VLAD: Of the individuals who MUSE worked on what percentage didn't continue use because of burning? Nurse: A small percentage. Probably less than 10%. VLAD: What was your criteria to establish that MUSE was effective? Nurse: Ability to penetrate and have intercourse. VLAD: Of those who were able to have intercourse what percentage had good rigid erections verses erections suitable for intercourse but not good turgid erections. Nurse: I don't know but if you come in you can ask the doctor. VLAD: Can you comment on your clinic's general protocol regarding treatment of ED? Nurse: Our policy has been to always start with the less invasive products first. Now that Viagra is out we will start with it followed by MUSE then injections. VLAD: How does this protocol compare with other clinics? Nurse: To my knowledge most follow the same protocol of always trying the least invasive method first. I hope this helped. Come on guys! Pick up the phone and ask some questions and give the others some input. I'm feeling like the big mouth on this board. VLAD

To: Jman who wrote (6808)	4/10/1998 2:32:00 PM
From: BigKNY3	Read Replies (1) \| Respond to of 23519

Jman <<BigKNY3,I am not a bio expert, but can you explain to me why the FDA would approve a label and the print/TV ads, and then later, after they are in production, ask for revisions/changes (I believe this is happening to Vivus). Isn't that the idea of FDA approval - that what they approve is ok to do?>> The approved package insert is the basis for all promotional and educational materials. Everything in an journal ad, tv ad or visual aid must be referenced to an indication and safety profile that was reviewed by the FDA. Now, comes the gray area....such as the MUSE TV ad. What the company considers appropriate to the package insert with a fair balance of efficacy versus adverse reactions may be very different from the FDA viewpoint. The result: a warning letter from the FDA demanding a cease and desist order, immediate revisions and corrective actions. Even though many Pharmas submit and discuss their materials with the FDA prior to release, I doubt this was the case for the MUSE ad. Good investing! BigKNY3