Cosmo Pharmaceuticals Methylene Blue MMX regulatory update:
filing of protocol for confirmatory phase III trial for Methylene Blue
Cosmo Pharmaceuticals N.V. today announced that it has filed for final comment the protocol and related statistical analysis plan with the U.S. FDA for the confirmatory phase III trial for Methylene Blue MMX, an investigational new drug product developed as an aid for the detection of colorectal lesions in patients undergoing routine screening and surveillance of colonoscopies.