Acorda Therapeutics has revealed that the FDA has refused its request to review the company's MS drug fampridine. The FDA asked Acorda to reformat its submission and provide more info on the drug. We are surprised by this development," said Acorda CEO Ron Cohen, in a statement. "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." Its stock plunged almost 20 percent on the news. Acorda release [1]
Links:
[1] http://www.fiercebiotech.com/press-releases/acorda-therapeutics-receives-refuse-file-letter-fda-fampridine-sr-nda