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.


Player Avatar JPG101 (< 20) Submitted: 7/20/2010 3:24:56 PM : Underperform Start Price: $5.12 VVUS Score: -400.34

I'm back at giving them a thumbs down (seems more efficient from a CAPS perspective to 'short' a stock more then once as they are going down).

From and earlier post where I gave a thumbs down to this company:

Qnexa from Vivus works but there are a 'few issues'...
The side effects of the individual components of the drug are impressive. Look up the original drug info of the two active drugs: not good! The word amphetamine: really not good... Cocaine and crystal meth could also be effective weight loss drugs but I doubt this would get anywhere either. The word suicide shows up: really really not good... Sanofi-Aventis’ Acomplia was rightfully rejected by the FDA for much less. The Europeans let Acomplia pass only to pull it later on after the suicide and depression issues became obvious.
The drop out rate in the higher dose group is very high as are the CNS side effects. Imagine 10 or 20 million patients on this drug walking (and driving...) the streets feeling like zombies? Not sure this would be very good for US productivity... Can you even drive or operate machinery while taking this cocktail of drugs? Should you be allowed to?
I doubt a cautious FDA will let this get far. A wise advisory panel will probably at best spit.
Although this is less of a concern the CEO is selling his stack in the company for whatever reason but that isn't a vote of confidence.
And it's not exactly a protected patented medication...
I'm betting (no real money: only 'CAPS money' ) that this will not pass an advisory panel.

Over 400 million market cap as I write this? Seems kind of expensive for a company with one major drug that just got toasted by a panel. The odds of the FDA going against a 10-6 vote? Slim at best. Even with the 2 years safety data the FDA will not let this drug onto the market. At best with really good 2 year safety data they could be issued a complete response letter. The 2 year safety data could also turn up all sorts of 'interesting things' (cariovascular issues, neuro-cognitive etc).


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