Cosmo Pharmaceuticals Methylene Blue MMX Regulatory Update: Type A Meeting outcome - Next steps
(WorldNews Health)

Dublin, Ireland - September 13, 2018 - Cosmo Pharmaceuticals N.V. (SIX: COPN) today provided a regulatory update after receipt of the official meeting minutes from the requested July 2018 Type A Meeting with the FDA Medical Imaging Division to discuss the path forward for MB MMX, a product for visualization of lesions in patients undergoing colonoscopy to improve overall detection of adenomas and carcinomas. Cosmo requested the Type A meeting to address the Complete Response Letter for the MB MMX NDA. According to the minutes, while some of the issues have been resolved, some disagreement with the review division remains. Cosmo will pursue the Formal Dispute Resolution process and file an...