Investing.com - Acorda Therapeutics Inc's (NASDAQ:ACOR) shares tumbled on Tuesday after the company received a Refusal To File (RAF) letter from the U.S. Food and Drug Administration for the company’s New Drug Application (NDA) seeking approval for Parkinson’s treatment INBRIJA.
The RTF is a setback as it means that the company’s NDA was not complete enough for the FDA to review. Missing information included the date that the manufacturing site would be ready for inspection and a question regarding the submission of the drug master production record. Acorda noted that the FDA did not request additional efficacy or safety data.
Acorda said it will immediately seek guidance from the FDA, including a Type A meeting, a specific FDA meeting to help a stalled product. The company added that it believes the issues are “addressable”.
Acorda's shares fell 24%.