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 [risk management plan] for women. I'll admit I got burned on Arena Pharmaceuticals (ARNA) after the "hidden" rat tumor data that was brought up at the advisory panel. Bonus question: Will FDA approve Arena Pharmaceuticals' lorcaserin on June 27? No. Adam Burden (Twitter: @crusadernz) Contest record to date: 11-2 Hometown: Auckland, New Zealand Age: 33 Occupation: Secondary school (high school) teacher of economics and Japanese. Founder of BioPharmCatalyst (but that's hardly an occupation!) The secret to your FDA drug approval picking success: I found my success was due to trusting my gut feeling and not over-complicating the process. To get this gut feeling requires many hours of hard work, skimming through every press release, 8-K and 10-Q filings released by all small-mid cap companies. It's a lot of work but after awhile you begin to develop a really good feel for each of the companies, the language they use and how open they are with investors. Also, keep an eye on companies that are filing resubmissions and those that are filing for the first time. Without a Special Protocol Assessment (SPA), a new drug applications needs to be perfect to succeed at first attempt. It's much easier the second, third time etc. Twitter helps as well. Two of my decisions were based on information from reliable tweeps. Your Vivus Qnexa prediction:Approval. Why? If there is ever an FDA advisory panel meeting, listen to it. I listened to the Qnexa meeting live for the original PDUFA date in 2010 and distinctly remember sensing that many on the panel who voted "no" would have voted "yes" had there been more data available. Vivus produced extra data following the complete response letter so I felt comfortable, especially given the indication is not for women of child-bearing potential. I think Qnexa will eventually get approved but I'm all too aware that there is a possibility that the PDUFA date could be extended. Bonus question: Will FDA approve Arena Pharmaceuticals' lorcaserin on June 27? No. @biopharminvest Contest record to date: 10-3 Hometown: Philadelphia, Penn. Age: 41 Occupation: University faculty member, specializing in biomedical research. Before that, several years postdoctoral experience at the National Institutes of Health. The secret to your FDA drug approval picking success: There is no "secret" in my prediction, just due diligence and knowledge in biomedical studies. With years of experience in this field, it is not hard to find the real story behind the publicly accessible clinical trial data and drug-development information. I have learned, however, that having bad or good data is not the always the sole reason for FDA's calls. I like to carefully evaluate drug safety and efficacy, then based on the overall benefit-risk assessment, predict the FDA's decision. Your Vivus Qnexa prediction: Rejection. Why? I think there is a chance FDA rejects this drug because of the long-term safety concern. Obviously, obesity is not a life-threatening disease, so new treatments should have sound safety profile before entering the market. Qnexa is comprised of phentermine and topiramate, the latter of which is already approved for epilepsy and migraine. The long-term adverse effects of Qnexa, including cardiovascular, teratogenicity and cognitive dysfunction risk, have not been sufficiently addressed in clinical trials. Since the over-the-counter weight-loss drug Xenical is already available, Qnexa should be scrutinized for long-term risk. I also think FDA should be extremely cautious about weight-loss drug safety due to previous experience with the fenfluramine market withdrawal in 1997 due to cardiovascular risk. I stand by my prediction for a Qnexa rejection despite a positive vote from the FDA advisory panel. Bonus question: Will FDA approve Arena Pharmaceuticals' lorcaserin on June 27? No.
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