BOSTON ( TheStreet) -- Welcome back to the Biotech Stock Mailbag.
Andy S. writes, "In your opinion, if Vivus (VVUS - Get Report) had this two-year Qnexa data available at the time of the FDA advisory meeting in July, do you believe it would have changed the outcome of the voting? And is it likely to have any bearing at this stage on the FDA's final response to the company next month? Seems to me, that while reassuring, it is too little too late now, accepting this data on the surface."
Great question! Absolutely, the two-year data would have mattered to the FDA's outside experts who reviewed Qnexa in July. Recall, the final vote was 10-6 against Qnexa's approval, with many of the panelists voting no because they wanted more long-term safety data.
The two-year Qnexa data announced this week would have assuaged some of the safety concerns. Would the data been enough to shift the vote to a positive recommendation for approval? I want to say yes, but the vote would still have been very close. An 8-8 tie? 9-7 in Qnexa's favor? It's hard to see it being any better than that, given the contentious nature of the discussion.If I'm right, not having the two-year data for FDA review and consideration by the panel in July was a major Vivus blunder. Looking ahead, I'm sure Vivus is rushing to prepare the new two-year Qnexa data for submission to FDA. I don't think this helps the company for the upcoming Oct. 28 approval decision date, however. Even if Vivus manages to submit the new data before Oct. 28, FDA will consider it to be a major amendment to the Qnexa review. I fully expect FDA to issue a complete response letter to Vivus on Oct. 28. No approval of Qnexa -- yet. The best case for Vivus will be if FDA accepts the two-year Qnexa data, which will likely trigger another six-month review. If you assume, conservatively, that FDA receives the new Qnexa data in December/January, the next approval decision date will come June/July 2011. Vivus also has to agree to other FDA demands, like pregnancy restrictions and a strict risk-management plan, but I can't see the company giving regulators a hard time about stuff like that.
John R. writes, "Have you seen the recent price action in Cel-Sci (CVM - Get Report)? There are claims of a buyout, rumors of a Teva Pharmaceuticals interest, LEAPS, new valuations up to $44 billion (LOL) and all the other old pump-and-dump claims this company has been through over the past decade. Please add some of your wisdom to this huge debacle being created on the wires and message boards. Thanks."