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Biotech / Medical : Acorda Therapeutics Inc.

ACOR 0.880

-13.8%

Apr 10 5:00 PM EST

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To: IRWIN JAMES FRANKEL who wrote (77)	10/14/2009 2:42:13 PM
From: Arthur Radley	Read Replies (1) of 120

HAWTHORNE, NY (TheStreet) -- The FDA advisory panel discussing Acorda Therapeutics'(ACOR Quote) drug Amaya appears to be leaning in the company's favor, according to one analyst watching today's proceedings. The discussion from the committee was quite favorable in our view, where it actually seemed the panel had more questions for the FDA's analysis than Acorda's analysis. Based on how the meeting is proceeding thus far, it seems to us that the negative tone by the author of the FDA briefing documents wasn’t necessarily shared at higher levels of the FDA," writes JP Morgan's Geoff Meacham in a mid-day note to clients. The FDA review, posted to the agency's web site Friday, raised questions about the clinical significance of the Amaya data demonstrating that the drug helps multiple sclerosis patients improve their walking ability. But in an unusual step, the FDA also added a disclaimer to the top of its review, which states: "The FDA background package often contains assessments and/or conclusions and recommendations written by individual FDA reviewers. Such conclusions and recommendations do not necessarily represent the final position of the individual reviewers, nor do they necessarily represent the final position of the Review Division or Office." In his assessment of the Amaya panel so far, Meacham said the FDA presentation was more balanced and didn't suggest a bias against approval. He added that experts on the panel had more questions about the FDA review than they did about the efficacy of Amaya. The advisory panel will vote later today whether or not to recommend Amaya's approval. The final approval decision rests with FDA. Acorda shares are halted today for the advisory panel meeting.

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