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Biotech Stock Mailbag: Xoma's Big Backers, FDA Approvals Contest

MAP is definitely a toss-up. I can see it going either way. It's very difficult to predict.

Of the three, I'd say Affymax is the easiest pick. I'll be really surprised if peginesatide isn't approved. I think most investors feel the same way.






Speaking of investor sentiment, let me run down the predictions for all the reader contestants in my FDA Drug Approval Contest:

MAP: 37% predict approval; 59% rejection; 4% no decision.

Affymax: 68% predict approval; 22% rejection; 10% no decision.

Chelsea: 53% approval; 43% rejection; 4% no decision.

A single contestant -- a biotech trader living in Texas who goes by the nickname "CBH" -- has a perfect 9-0 record in the contest so far. CBH predicts rejections for MAP's Levadex and Chelsea's Northera, and an approval for Affymax's peginesatide.

@Bullbear123 "@adamfeuerstin $TLON you were wrong again."

I was wrong about Talon Therapeutics (TLON). I didn't think the company would be capable of getting a positive vote for its leukemia drug Marqibo from Wednesday's FDA advisory pane. But that's what happened, even if the 7-4 vote (with two abstentions) in favor of Marqibo wasn't exactly a ringing endorsement.

I put abstentions in the "no" bucket, so the real vote was more like 7-6 recommending Marqibo's approval, which is even a weaker signal of support.

The FDA drug approval decision date for Marqibo is May 13.

To Talon's credit, the company did a nice job Wednesday framing Marqibo as a benefit for leukemia patients with no other medical options. Having Dr. Sue O'Brien, a respected oncologist from M.D. Anderson Cancer Center, advocating for Marqibo definitely helped sway some panel member votes. Smart strategy, Talon.

Working against Talon is Marqibo's "meh" efficacy, which was noted even by panel members who voted in favor of the drug. I didn't hear a single panel member effusively praise the drug. Most of the explanations for "yes" votes Wednesday were along the lines of, "Well, these patients are really sick, Marqibo may help them but probably won't hurt so I'll vote to recommend approval."

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