Vivus: What Happens Next?

My live blog of the Qnexa panel attracted more than 10,000 readers Thursday -- an amazing response. Thank you! Naturally, the coverage brought its share of reader comments and questions. Here's a small sampling of the email I received:

Patrick writes, "I think Vivus could challenge the FDA because of the SPA [Special Protocol Assessment.]… If the FDA wanted more long-term data, why wasn't that requested as a part of the SPA? Seems a little contradictory to come back with a rejection because Vivus didn't provide enough data, even though FDA designed the trial."

Along the same these, Andy S. writes, "You did a great job and a great service to the investing community with your live blog. Although I was long the stock and am disappointed with the resulting vote, that’s life. My big question is how could the company and the FDA design a trial like this and not adequately address the kinds of safety issues that arose during this panel hearing? It borders on stupidity to conduct trials like this that leave open the kinds of questions and concerns that arose before appearing at a panel. I wonder if in this case the FDA may not make a different decision in October given that the vote was close and the efficacy of Qnexa does not appear to be at issue."

It does seem like Vivus and FDA initially agreed that a single year's of safety data were enough, but clearly, the outside panel disagreed. Special protocol assessments around trial design are not written in stone; these agreements are fungible. I think Vivus does have a case to make that one year of safety data are sufficient, but it's probably not a winning argument at this point.

Kevin R. writes, "Thanks for all the hard work today. Good job. I am long Arena and think we will get the approval because of safety. Once again, good coverage and have a great day."

Mark G. emails, "You did a fantastic job on the blog. The cardiovascular issues and lack of data in the studies, as I mentioned the other day, might have been [Vivus'] undoing… Next batter -- Arena! -- with the safest set of data."

Mark is right. Qnexa was undone by cardiovascular safety issues, specifically concerns about an increase in heart rate tied to the drug. [This despite other data showing Qnexa lowered blood pressure.]

The controversy over the GlaxoSmithKline(GSK) diabetes drug Avandia also played a definite role in Thursday's proceedings. Many of the experts on the Qnexa panel spent the prior two days deliberating the heart safety of Avandia. I think this put panel members in an extra cautious safety mode.

Bob B. writes, "Just to let you know that I really liked your coverage of Qnexa today. I learned a lot and I think you were fair and balanced. For what's its worth, my bet is that $3-4 at the open tomorrow [for Vivus] is on the low side. I think a school of thought will emerge that problems can be remedied with more data acquisition. So my bet is $6-$7.

Norm F. writes, "Well, it was certainly an interesting day. Are you coming around on the Arena safety advantage now? The Arena trials were far more robust, safety was clearly superior, side effects lower. I just hope two years of cardiovascular data will be enough for the next panel. Arena should certainly be prepared."

Steve writes, "Thanks for the work you put into the Vivus review panel and blogging all day…You really missed the boat. Arena is the one you should have backed all along and now I think you have the data you need to assert its primacy."

Lastly, an email from Eldon W. "Thanks Adam, for giving us a bird’s eye seat for the FDA review panel. It was interesting and fun."

-- Reported by Adam Feuerstein in Boston.

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