Why the FDA Won't Approve Lorcaserin and Qnexa (Yet)

Hot Air Images via WikipediaI don't see much hope for Arena Pharmaceuticals, Vivus, or Orexigen at gaining FDA approval at this time.  I see it as a bunch of hot air and will not be approved with this conservative FDA panel right now.  That's not to say a CRL is necessarily a bad thing but at what point does the funding run dry?  Shorting these stocks wouldn't be a bad idea.  Especially, Vivus and Orexigen.  At a lofty 5 and 6 points it won't take much time to take the plunge to 2.

Wikinvest--ARNA, VVUS, OREX

By Brian Orelli
More Articles

October 19, 2010
 
After months of speculation and a pair of Food and Drug Administration advisory panels, FDA decisions for Arena Pharmaceuticals' (Nasdaq: ARNA) lorcaserin and VIVUS' (Nasdaq: VVUS) Qnexa are finally upon us.

Arena's PDUFA date is Oct. 22, while VIVUS' date with destiny is six days later on the 28th. The Prescription Drug User Fee Act (PDUFA) sets the goal for the FDA to make a decision by then, but the FDA is free to make a decision at any point before or after that date. A decision on lorcaserin especially could be delayed since the FDA advisory panel met just last month.

What's the chance of lorcaserin and Qnexa gaining FDA approval? I'd put it somewhere between unlikely and nonexistent.

If you would like more Subscribe To BioPharma Investor for everyday stock news and up to date FDA decisions.  Biopharma Investor

F.D.A. Panel Votes Against Obesity Drug

F.D.A. Panel Votes Against Obesity Drug
By ANDREW POLLACK
Published: July 15, 2010 From the NY Times

A federal advisory committee voted narrowly against endorsing a drug vying to become the first new prescription medicine for obesity in more than a decade, signaling heightened concerns for possible health risks associated with a new generation of diet pills.

The advisory committee to the Food and Drug Administration voted 10 to 6 that the safety concerns, like increased heart rate, possible birth defects and psychiatric problems, overrode the potential benefits of the drug, called Qnexa and developed by Vivus.

Vivus' Qnexa Not Recommended By FDA Advisory Committee

Image via Wikipedia The U.S. Food and Drug Administration has refused to recommend the Vivus Inc (NASDAQ: VVUS) diet drug Qnexa for approval. Citing multiple safety concerns, the panel narrowly rejected recommending the pill, which studies had shown to be effective in helping overweight people lose weight. While the FDA is not bound to the recommendations of its panels, it follows them most of the time.

Vivus Inc.'s FDA Review Of Weight Loss Drug Qnexa could Hint At Future Approval For Arena And Orexigen

Tomorrow is a big day for Vivus, Inc. and stock VVUS. Vivus is preparing tomorrow for the FDA's Endocrinologic and Metabolic Drugs Advisory Committee review panel on the weight loss drug Qnexa. I wrote an article on this subject last year based on their Phase III clinical trial results titled Vivus's Qnexa Drug Approval Makes It a Nice Trade, and was impressed with the long-term growth potential in the $40B weight loss industry.