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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 (63)	10/9/2009 9:26:22 AM
From: Arthur Radley	Read Replies (1) of 120

Jim, Appears that we have the placebo issue all over again. As you know........I wanted this one to be positive. I don't think that it's dead, but barrier just got taller for Acorda to defend before the panel. Drug met main goals of two clinical trials * Secondary review indicated 'very limited effect' * FDA advisers to weigh drug on Wednesday WASHINGTON, Oct 9 (Reuters) - Acorda Therapeutics Inc's (ACOR.O) proposed drug to help multiple sclerosis patients walk better appears to have a 'very limited effect' even though the drug met its main clinical trial goals, U.S. regulatory staff said in documents released on Friday. While the findings showed a statically significant difference in patients' walking ability, the average time it took patients to walk 25 feet was not different between those given the drug versus a placebo, Food and Drug Administration staff said. "For these reasons, it appears that the clinical meaning of the differences seen ... is in question," FDA staff said in their review. Acorda aims to sell the drug under the brand Amaya. It contains fampridine, which is widely known to cause seizures -- a factor that also must be weighed, the FDA staff said. The documents were released ahead of a public meeting on Wednesday to discuss whether to recommend FDA approval. The FDA will seek a recommendation from its outside advisers before later making an approval decision. (Reporting by Susan Heavey, editing by Dave Zimmerman

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