) -- Bad news from Europe is in store for
(ARNA - Get Report)
. FDA advisory panels will deal harshly with
(DCTH - Get Report)
(AVEO - Get Report)
. An early approval filing in the cards for
(ZIOP - Get Report)
sarcoma drug emerges as a winner. These are some of the predictions made by investors who submitted entries to
FDA Drug Approval Contest
I hesitate to call these picks "consensus," but 113 entries are a decent sample size from which to gauge retail investor sentiment. Accuracy can also be hit and miss. The crowd participating in my previous two FDA approval contests was correct collectively 80% and 57% of the time.
I crunched the numbers. Here are your predictions:
: 55% of investors believe FDA will grant permission to seek accelerated approval for eteplirsen. Forty-five percent predict no accelerated approval. There isn't much daylight between those two numbers. I've written previously about Wall Street investors leaning more bearish on the accelerated approval decision; so it doesn't surprise me to see a more bullish stance taken by retail investors, even if just a slight one.
: Investors who entered my contest take a dim view of Belviq's approval prospects in Europe. The margin was huge: 76% predict European regulators reject the weight-loss pill while only 24% say it will be approved. Areniacs like to shout "Idiot!" (or worse) at anyone who dares to suggest European regulators will be less than sanguine with Belviq's mediocre efficacy and still-unanswered questions about its long-term safety. Surprise, it's the Areniacs who are in the minority.
: Seventy-two percent of respondents predict a recommendation favoring Probuphine's approval by an FDA advisory panel. Twenty-eight percent say the panel will vote against the implantable formulation of buprenorphine.
: FDA approval of APF530: 63%. Rejection: 37%.
: FDA approval of BG-12: 87%. Rejection: 13%
: FDA approval of oral Remodulin: 60%. Rejection: 40%. This is another relatively close call. FDA appeared to come down hard on oral Remodulin when the drug was rejected last year, but then regulators granted United Therapeutics a surprisingly short review period after the drug was resubmitted (without new clinical data.)