Acorda Therapeutics Inc. Message Board

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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: kenhott who wrote (27)	4/23/2009 3:29:02 PM
From: kenhott	Read Replies (1) of 120

23ish days between getting the RTF letter and putting in the reply to the FDA. The only reasonable answer is that ACOR made a simple actionable mistake(s) from the FDA's perspective. If one looks at the FDA reference re: RTFs, one would find a checklist of "simple" stuff/forms that must be included with the NDA package. I have to believe now that they just left something out maybe some parts of the fed study that they mentioned during the cc. Other than that, formatting should only be an issue if it is badly screwed up. Which is also possible but the fix is pretty fast for a major formatting screw up.

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