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
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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.

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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.