Acorda Therapeutics Receives Refuse to File Letter from FDA on Fampridine-SR NDA
Last update: 3/31/2009 7:00:02 AM
--Company to Host Conference Call at 8:30 a.m. Eastern Time Today--
HAWTHORNE, N.Y., Mar 31, 2009 (BUSINESS WIRE) -- Acorda Therapeutics, Inc. (ACOR) announced today that the Company received a refuse to file letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for Fampridine-SR, a novel therapy being developed to improve walking ability in people with multiple sclerosis (MS).
The FDA has raised what it termed "format issues" regarding the eCTD (electronic) submission, requesting that some of the data in the NDA be reformatted, as well as requesting that some additional supporting information be included in the filing. The FDA has not requested or recommended additional clinical or other studies.
"We are surprised by this development," stated Ron Cohen, M.D., President and CEO of Acorda Therapeutics, "We plan to address the issues raised in this letter with FDA expeditiously as we believe Fampridine-SR is potentially an important, first in class treatment option for people suffering with MS."
The Company plans to request a meeting with FDA as soon as possible to discuss its comments on the NDA filing.
Conference Call and Audiocast
Acorda will host a conference call Tuesday, March 31, 2009 at 8:30 a.m. Eastern Time. To participate, please dial 866-783-2143 (domestic) or 857-350-1602 (international) and reference the access code 85118409. To access the audio webcast, please go to the Investor Relations "Calendar of Events" section of the Acorda website at , or you may use the link: .
A replay of the call will be available from 11:30 a.m. Eastern Time on March 31, 2009 until April 30, 2009. To access the replay, please dial 888-286-8010 (domestic) or 617-801-6888 (international) and reference the access code 59152215. The archived teleconference will be available for 30 days in the Investor Relations section of the Acorda website at . |
