"Acorda is racing Biogen Idec Inc., Merck KGaA and Novartis AG to sell the first pill for multiple sclerosis, a disease now managed by injected medicines with $6 billion a year in worldwide sales. Acorda said the FDA will expedite its review of Fampridine as a “priority,” a process that typically takes six months, compared with 10 months for typical new drug applications.
“The priority review is a positive surprise,” said Phil Nadeau, an analyst with Cowen & Co. in New York, in a note to clients today.
Acorda received a “refuse to file” letter from the FDA on March 30. The agency sends such letters to companies whose new drug applications are incomplete, according to the FDA Web site."