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Biotech Stock Mailbag: Amarin

Granted, this is cancer we're talking about, so relatively more risk is acceptable. But the FDA's request for lots more patient hospitalization data suggests heightened scrutiny on Chemosat's safety profile relative to its purported benefit.

Via Twitter, @Detroitblues comments on my dissection of reaZin, the "prescription medical food" that Adeona Pharmaceuticals (AEN) wants to market to people with Alzheimer's disease.

"$AEN what awesome work by @adamfeuerstein on the Alzheimer's test results. Ton of $ could've been made. Tip of the hat Adam and all for free."

Thank you. I'm just wondering if Adeona CEO James Kuo has found the time to read the column yet.

More tweets, this one from @aeroforce: "What's your outlook on Dendreon (DNDN) for the year?"

First, think about the first-quarter results. Dendreon reports on May 2, with the current analyst consensus for Provenge sales at $29 million.

A more important near-term focus for investors will be second-quarter Provenge sales. [Current consensus: $59 million.] That's because second-quarter sales will provide the truest measure of real patient demand to date, given the FDA's recent approval for the manufacturing capacity expansion at Dendreon's New Jersey plant.

After that, look for when Dendreon reaches the 2,000th prescription for Provenge, now forecasted by the company to occur in July. If patient No. 2,000 occurs before July, investors will be more confident that Provenge is on track to meet 2011 revenue targets. Obviously, if patient 2,000 comes much later, like in the fall, investors won't be happy.

Right now, however, Dendreon is riding a strong wave of investor optimism. The malaise that hit the stock in February and March seems to be dissipating with a very strong April, buoyed by research reports indicating stronger Provenge demand.

Heather D. writes, "Any word on FDA approval of abiraterone acetate for prostate cancer? Thanks for any info you can share."

Johnson & Johnson (JNJ - Get Report) has not disclosed a precise FDA approval decision date for abiraterone but the best guess is June 20, based on when the drug was filed. I have heard unconfirmed rumors that the abiraterone approval might come early.

Abiraterone's initial approval will be for the treatment of post-chemotherapy prostate cancer patients, so the drug should not compete with Dendreon's Provenge, at least not right away. J&J is conducting clinical studies to move abiraterone treatment before chemotherapy, which could make the drug more directly competitive against Provenge. [Opinions differ on that point.]
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DNDN $0.06 -6.02%
AMRN $1.83 0.00%
AZN $28.96 0.00%
DCTH $0.32 0.00%
JNJ $112.08 0.00%


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