Biotechnology company Acorda Therapeutics, Inc. (ACOR), Tuesday, revealed that it received a "refuse to file letter" from the U.S. Food and Drug Administration, or FDA, pertaining to its New Drug Application, or NDA, for Fampridine-SR, a new therapy under development for improving the walking ability in people suffering from multiple sclerosis.
The Hawthorne, New York-based company said that the FDA has raised "format issues" concerning its electronic submission, and has called for the reformatting of some of the data in the NDA. The agency has also asked for some additional supporting information.
The company, however, noted that the FDA has not requested or recommended additional clinical or other studies. The company said it will seek a meeting with the FDA at the earliest to discuss its comments on the NDA filing.
As per the FDA web site, incomplete NDAs become the subject of a formal refuse-to-file action, with the applicant receiving a letter detailing the decision and the deficiencies that form its basis. This decision must be forwarded within 60 calendar days after the NDA is initially received by CDER.
ACOR closed Monday's regular trading on Nasdaq at $24.90, down $0.21, on a volume of 336,400 million shares.
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