Bulls, Bears Fight Over BioCryst: BioBuzz
So, if swine flu is causing countless U.S. children to suffocate to death, hundreds, maybe thousands, of doctors must be swamping BioCryst's switchboard with requests for peramivir shipments, right?
Thursday at an investor conference, BioCryst was asked how many patients have been treated with peramivir under this emergency use program that is endorsed by the FDA. The company's response: "High single digits." Really? So, if we give the company the benefit of the doubt, nine patients in the U.S. have been treated with peramivir. Nine.New FDA Guidance Looks Good for Dendreon
Dendreon(DNDN) has yet to resubmit Provenge to the FDA, but regulators already appear to be supportive. The FDA issued new draft guidance for cancer vaccines last night that validate many of the approaches Dendreon took in the design of its clinical trials and the quality control measures it uses to ensure the potency of the prostate cancer vaccine. "These are the first FDA statements that acknowledge the validity of Dendreon's regulatory approach for Provenge. The guidance also appears to be almost identical to the approach Dendreon has taken to monitor Provenge activity for quality control," said Deutsche Bank biotech analyst Robyn Karnauskas. She has a buy rating on Dendreon with a $36 price target. Dendreon shares rose 7.8% to $28.90 Thursday. The stock has been strong in recent days as investors anticipate the company's analyst meeting on Sept. 24. -- Reported by Adam Feuerstein in Boston Adam Feuerstein will be the featured guest on TSC Live at noon EDT Tuesday, Sept. 22. Send him your questions by: Emailing us at tsclive@thestreet.com; posting them on our Facebook page, facebook.com/thestreet; Tweeting us @thestreet_news with #tsclive; or posting them on the live show page in the comments section. Bookmark the TSC Live page now.>To order reprints of this article, click here: ReprintsTheStreet Premium Services For Personal Service: 877-471-2967
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