) -- Bad news from Europe is in store for
. FDA advisory panels will deal harshly with
. An early approval filing in the cards for
sarcoma drug emerges as a winner. These are some of the predictions made by investors who submitted entries to
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.)
: FDA approval of Amitiza: 76%. Rejection: 24%.
: FDA approval of Lymphoseek: 72%. Rejection: 28%.
: FDA approval of Procysbi: 81%. Rejection: 19%.
: The bears growl again. Fifty-seven percent of respondents expect the FDA advisory panel to vote against Tivopath; 43% predict a positive vote. Aveo's argument that Nexavar crossover mucked up Tivopath's survival benefit doesn't appear to be persuasive to investor contestants.
: Fifty-four percent predict the FDA panel will slap down Melblez; 46% say the panel will be positive. Close again, but leaning bearish. But check this out: 64% predict FDA will ultimately reject Melblez while 35% says it will be approved. Weird. Is it a fluke that more people predict Melblez's FDA rejection than a negative panel? That suggests a group of investors believe FDA will overturn a positive vote by the panel -- a relatively rare outcome.
Sure enough, there are 11 contestants -- almost 10% of the total entrants -- who are predicting a positive FDA panel for Melblez followed by an FDA rejection. Very interesting. If you're in this group and happen to read this column, drop me an email and explain your thinking.
: Another runaway, with 78% predicting positive results from the palifosfamide clinical trial versus just 22% believing the trial comes up negative. If everyone is so confident in a Ziopharm win, why doesn't the stock trade better going into the results announcement at the end of March?
For anyone interested, my personal picks are in line with consensus with the exception of United Therapeutics, where I predict FDA rejection of oral Remodulin.
I voted yes on Sarepta accelerated approval filing, no on Arena in Europe, a positive Titan panel, FDA approvals for A.P. Pharma, Biogen, Sucampo, Navidea and Raptor. I'm on the fence with Aveo's FDA panel but ultimately predicted a negative vote (just barely, I can see it going the other way, too.) I'm definitely negative on Delcath's FDA panel and the ultimate FDA approval decision. Finally, I'm also positive on Ziopharm.
-- Reported by Adam Feuerstein in Boston.
Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback;
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