BOSTON ( TheStreet) -- U.S. regulators have delayed by three months a decision on the approval of Vivus' obesity drug Qnexa. The new approval decision date has been moved to July 17 from April 17.
Vivus and the U.S Food and Drug Administration need the extra time to reach agreement on a risk management plan, or REMS, which will put in place safeguards and restrictions on the way the company can market and sell Qnexa.Does the extra time requested by FDA suggest the agency is leaning towards approving Qnexa? I've asked the top six contestants in TheStreet's 2012 FDA Drug Approval Contest to answer this very important question. These guys have racked up an impressive track record to date, so pay attention to what they say. For the record, none of the contest leaders correctly predicted the delay in the Qnexa decision, but then only 7 of the 60 contestants overall got this one right. However, the reasons for and against Qnexa approval still apply. @cbhwatch Contest record to date: 12-1 Hometown: New Braunfels, Tex. Age: 30 Occupation: Accountant, biotech investor for five years. The secret to your FDA drug approval picking success: Blogs/articles I read from people I follow on Twitter, reading Twitter comments, reading SEC filings, and most importantly -- luck. I travel a lot for work, so in the evenings I read just about anything relating to biotech. Your Vivus Qnexa prediction: Approval. Why? Best efficacy out of all three obesity drugs; positive Orexigen Therapeutics (OREX) panel with lack of efficacy; and the REMS
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