VIVUS, Inc. (NASDAQ:VVUS)

There are currently 1000 VVUS shares in my fund with break-even of around -24.08 USD.
http://caps.fool.com/Blogs/fund-trades/705717.

strong pipeline and takeover play

The obesity drug they are waiting for FDA approval, will be quite an achievement if approved. There's not much else that can be done for all of our fat ass American kids who have no interest in exercising or eating anything halfway decent. A "quick fix" drug is their only hope. Unfortunately.

QVT Financial and Orbimed are the largest shareholders.

Has a great new weight loss drug coming

OREX will beat them to it.

$1 billion dollar well with no buckets in it...until VVUS and OREX.

FDA will accept Qnexa; Vivus will file the Avanafil NDA and Vivus will do at least one major deal in 2011

Its time, there is compete

The FDA has proven to be hesitant toward diet drugs.

cheap!!!

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?

dead horse

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).

JPG

I am in this business, and have spent countless hours analyzing the 3 competing obesity drug companies that have FDA action dates this year. The only people who praise Qnexa's great results and the others' mediocre results are those who have not done enough research. Vivus has serious problems in its future, and the share price will continue to decline. Margin calls will soon be a factor and that could accelerate the decline. If you think the mgmt's unwillingness to admit defeat means you could get a positive surprise from the FDA in October, you are crazy. It is only gonna get worse for Vivus, and better for Arena. Lorcaserin's big future is in being prescribed PART-TIME with phentermine, which will yield excellent results and accelerate royalty/milestone payments from Eisai to Arena. Read the FDA filings for side effects (carefully) for these companies, and look at the stock sales and management turnover data, too.
Contrave is not as bad as Qnexa, but OREX mgmt has demonstrated some lack of skill, so that has to concern you about their likely performance at the December FDA panel. Whoever was quicker than me to short VIVUS Friday morning should be rewarded nicely, by the way!

Drug not approved.

I guess it wil not get the approval they are looking for

obesity fever ! get fda feedback on 7/15/10

I had Vivus on my watchlist to green thumb under 11 ahead of the FDA advisory panel for Qnexa on July 15, and surely enough they dropped a clean point today and slipped under my threshold. Some jitters perhaps? Of the three weight loss drugs vying for FDA approval in the coming year, Qnexa unquestionably has the best efficacy data, especially after Orexigen's embarrassing downward revision of their data for Contrave. With the recent tendency towards warm and fuzzy advisory panels, I think risk/reward is in favor of a positive outcome here. The actual FDA approval could be a different story, but I expect to be long gone by then. If the FDA decides to post negatively phrased documents in advance of the advisory panel that knock the share price back below 9, this could be a buy in real life. In addition, the company has the rapid-onset erectile dysfunction drug avanafil waiting in the wings to submit for approval.