MOUNTAIN VIEW, Calif. (TheStreet) -- By day, Joseph Lee is a graduate student pursuing a PhD in pharmaceutical sciences and pharmacogenomics. By night, he's the "FDA Panel Whisperer" -- the creator of FDATracker.com, a unique web site that predicts outcomes of FDA advisory committees based on the historical voting records and behavioral analysis of participating panelists.
Lee has crunched the data on the 22 panel members who will sit in judgment of Vivus (VVUS) and its obesity drug Qnexa tomorrow and he's not encouraged. His prediction: 10 experts will vote to recommend Qnexa approval but the remaining 12 will vote against. That's a very close vote, made more so by Lee's acknowledgement that one or two votes could swing in either direction, according to his analysis.
Guessing the outcome of any FDA advisory panel is a big challenge; Vivus' panel is even more difficult to handicap because FDA invited eight experts who have not previously participated in any of the obesity panels held last year.For that reason alone, I wouldn't necessarily take Lee's Vivus analysis to the bank, but his research is thorough and a compelling read if you're at all interested in following tomorrow's Qnexa presentations and the volatile deliberations that will undoubtedly follow. Assessing the risk of birth defects caused by the topirimate component of Qnexa is likely to be the focal point of Wednesday's FDA panel debate. FDA invited Suzanne Gilboa from the National Center on Birth Defects and Development Disabilities at the CDC to present at Wednesday's panel. Her testimony could prove to be influential on the final vote. Of the eight "new" votes on the Qnexa panel, Lee has three experts voting yes and five voting no. Twelve experts on Wednesday's panel also participated in the last Qnexa panel. They voted 5-7 against the drug previously. This time, Lee has only one of these experts changing to a positive vote, bringing the tally in this group to a 6-6 tie. Two additional experts invited to review Qnexa tomorrow participated in FDA panels for the two other obesity drugs last year from Arena Pharmaceuticals (ARNA) and Orexigen Therapeutics (OREX). Lee predicts these two experts will split their votes on Qnexa. That's how Lee comes up with his prediction for a 10-12 vote against the weight-loss drug. It's hard to get a solid read on a consensus Wall Street expectation for the Qnexa panel, but FDA's review of the drug released Friday revealed few surprises. This seems to have left investors leaning toward predicting a positive vote, although almost everyone predicts a split/close vote. Vivus shares rose 7% Friday after the FDA release of its briefing documents but the stock was down 3% Tuesday to $11.64 per share. I encourage you to read Lee's breakdown on how each of the panel members may vote on Qnexa based on their voting record from past obesity drug panels or statements made at other FDA panels. Tomorrow night, we'll learn if the "FDA Panel Whisperer" is accurate or not. FDA panel members predicted to vote for Qnexa's approval, according to Lee: Melanie Coffin, Eric Felner, Allison Goldfine, Jessica Henderson, Sanjay Kaul, Michael Rogawski, Robert Smith, Myrlene Staten, Abraham Thomas, Susan Yanovski. FDA panel members predicted to vote against Qnexa's approval, according to Lee: Erica Brittain, Ken Burman, David Capuzzi, Robert Clancy, Janet Cragan, Katherine Flegal, Ed Gregg, Mike Lauer, Elaine Morrato, Sonja Rasmussen, Lamont Weide, Almut Winterstein. --Written by Adam Feuerstein in Boston.
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