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

To: James Baker who wrote (5751)	3/3/1998 8:14:00 AM
From: BigKNY3	Read Replies (2) \| Respond to of 23519

James: Nothing involving the FDA is a sure thing. But, the odds are in Viagra's favor. I hate to be the bearer of bad VVUS news. But, this information was just released concerning a FDA meeting held last Friday. In my opinion, this problem should have been released in a press release by VVUS on 2/20/98. BigKNY3 Vivus Muse DTC broadcast, print ads cited for insufficient risk information in Feb. 19 notice of violation letter, FDA ad division branch chief Ostrove says. : VIVUS MUSE DTC TV/PRINT AD RISK INFORMATION CITED IN FDA NOTICE OF VIOLATION LETTER dated Feb. 19 regarding the company's erectile dysfunction therapy. "Our concern with both the broadcast ad and the print ad was with the risk information," Division of Drug Marketing, Advertising and Communications Acting Marketing Practices and Communications Branch Chief Nancy Ostrove told a Drug Information Association drug marketing conference Feb. 27. Both the 30-second TV ad and the print ad feature black type over a yellow background. In the TV ad, a male voice says: "Attention impotent men. All 20 million of you. Impotence is usually a physical problem, not a mental one. And for many men it can be treated with Muse." A female voice takes over for the risk information, warning that those with sickle cell disease or trait or other blood disorders should not take Muse. "In clinical trials, one in three men reported genital pain, causing 7% to drop out," the voice continues. "Three percent of patients reported symptoms from lowering of blood pressure." The male voice returns to give the toll-free number, while the screen text tells viewers to see the print ad in Time magazine. The man ends by saying: "See your doctor, and buy some flowers." "My concern with that was with the communication of the risk information, " Ostrove said of the TV ad. "Notice how women's voices are so much more reassuring than men's. They always -- well not always, but in many cases -- have women's voices reading the bad stuff. It's very interesting." The companion print ad says "Impotence is optional" in large black type across a yellow background on one page. "For many men there may be a solution," the second page continues. The rest of the text, including the risks, reads similarly to the TV ad. The risks are in smaller print than the benefits portion of the text. "We had some problems with [the language] because, first of all, impotence isn't optional," Ostrove commented. "Now it's possible it may be optional for many men, but we didn't feel that the big call out on one big page with black and yellow, then the next page something else, was sufficient context. It wasn't reasonably comparable in terms of the information for both risk information and indication information. That is our allegation at this point." "I'm not sure that the company has responded yet," Ostrove said, "so keep in mind that the company may not agree with us on our judgment. " Vivus attempted to place Muse (alprostadil) scrolling text ads during the Super Bowl, but was turned down by NBC. Since then, Muse ads have aired during national news programs including CBS Evening News, 60 minutes and CNN. Print ads appeared in a variety of national and health-related magazines.

To: James Baker who wrote (5751)	3/3/1998 12:22:00 PM
From: LoLoLoLita	Read Replies (1) \| Respond to of 23519

>>Now the laws of probability would dictate that sooner or >>later that 100% string will be broken, so this is not a >>very good argument IMO. James, I have training in mathematics and risk analysis. Could you please elaborate on your claim above, in essence, that future behavior will ALWAYS show deviations from observations of past behavior? It's like you're saying that just because we've always had a 100% probability that a given coin comes up either heads or tails (akin to the 4-8 month FDA approval range you cited), THEN, sooner or later, we're bound to have that tossed coin come up as something else (that is, other than heads or tails). Cheers, David P.S. the doctors here all quibble over technicalities, and it makes for a much better discussion.