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Best And Worst FDA Drug Approval Stocks of 2013


Sucampo Pharmaceuticals (SCMP): FDA approval of Amitiza: 76%. Rejection: 24%.

Navidea Biopharmaceuticals (NAVB): FDA approval of Lymphoseek: 72%. Rejection: 28%.

Raptor Pharmaceuticals (RPTP): FDA approval of Procysbi: 81%. Rejection: 19%.

Aveo Pharmaceuticals: 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.

Delcath Systems: 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.

Ziopharm Oncology: 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; click here to send him an email.
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