VIVUS, Inc. (NASDAQ:VVUS)

CAPS Rating: 2 out of 5

A pharmaceutical company dedicated to the development and commercialization of therapeutic products using patented proprietary formulations and novel delivery systems and by seeking new indications for previously approved pharmaceutical products.

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Player Avatar bubuzim (96.97) Submitted: 9/24/2010 10:18:57 AM : Underperform Start Price: $7.16 VVUS Score: -227.19

Getting and maintaining FDA approval has been a whole new ballgame since Vioxx. Unfortunately for Vivus and other weight loss companies, it's guilty until proven innocent by means of expensive long-term clinical trials. Will Vivus survive? Probably, but at what cost? Look at Cardiome, which practically gave away its North American market to stay alive. It will take years and muchos $ to pass this hurdle. The recent 2nd year data doesn't address the main concerns, and its sample size is too low to make a real dent. Again, the main concern is pregnancy. Deformed children (and suicidal thoughts, heart trouble, etc). ~15 pregnant mothers out of ~3000 person-years, despite doctors' specific warnings. Even if the risk is 'only' 1/100 babies, you need probably 100k-200k person-years to have statistical power. How many of us could be comfortable with a risk of 1/100 babies coming out deformed? Maybe the next weight-loss contender should include birth-control as part of the pill?

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