Cosmo Pharmaceuticals Methylene Blue MMX Regulatory Update:
Initial appeal outcome – Next steps
Cosmo Pharmaceuticals N.V. today provided a regulatory update after receipt of the answer to the initial appeal filed after reception of the Complete Response Letter from the U.S. Food and Drug Administration (FDA) for Methylene Blue MMX, a product for visualization of lesions in patients undergoing colonoscopy to improve overall detection of adenomas and carcinomas.