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 zzlangerhans (99.85) Submitted: 6/15/2010 3:30:24 PM : Outperform Start Price: $11.00 VVUS Score: -70.22

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.

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Member Avatar JPG101 (< 20) Submitted: 6/24/2010 5:54:33 PM
Recs: 1

Qnexa from Vivus works but there are a 'few issues'...

The side effects of the individual components of the drug are impressive. The word suicide shows up: not good... The word amephatimine: really not good... Cocaine could also be an effective weight loss drug but I doubt this would get anywhere either.
The drop out rate in the higher dose group is very high as are the CNS side effects.
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 and not even CAPS till it regains some of it's lost ground: at 9.5 as I write) that this will not pass an advisory panel.


Member Avatar kevinag24 (87.16) Submitted: 7/10/2010 1:43:20 AM
Recs: 0

I checked out the insider selling myself....very shady.

Member Avatar BioBat (23.65) Submitted: 7/15/2010 4:23:44 PM
Recs: 1

The FDA has been raising safety concerns for well over a year now so it should come as no surprise that the advisory panel voted against approval. That said, the panel seemed pretty open to approval pending more safety data so I'm betting this will be approved eventually. There will be some cheap obesity stocks at tomorrow's opening that would be worth an investment.

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