=Acorda Therapeutics (ACOR) : FDA rejects application for Parkinson's treatment

Acorda Therapeutics received a Refusal to File letter from the FDA regarding its NDA for INBRIJA; co will seek immediate guidance, including a Type A meeting with the FDA, to respond to the issues

• Upon its preliminary review, FDA determined that the NDA, submitted on June 26, 2017, was not sufficiently complete to permit a substantive review. FDA specified two reasons for the RTF: first, the date when the manufacturing site would be ready for inspection, and, second, a question regarding the submission of the drug master production record. FDA also requested additional information at resubmission, which was not part of the basis for the RTF.
• The Company will seek immediate guidance, including a Type A meeting with the FDA, to respond to the issues, which it believes are addressable, and to seek clarification of what additional information will be required. The FDA has not requested or recommended additional clinical efficacy or safety studies.