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The safety and efficacy of Methylene Blue MMX modified release tablets administered to subjects undergoing screening or surveillance colonoscopy.
12 Mar 2019
FDA Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER) denied Cosmo's last appeal while reiterating the need of a phase III confirmatory trial for approval of the drug.Company has no intention to peruse any additional appeal with the FDA. The company intends to conduct a phase III confirmatory trial and will present a new clinical protocol to the FDA with different endpoints.
05 Jun 2018
Results presented at the Digestive Disease Week 2018
23 May 2018
According to a Cosmo Pharmaceuticals media release, the CRL states that the FDA has determined that it cannot approve the NDA in its present form. The CRL states that although the outcome from this trial has translated in a statistically significant outcome, the outcome is not sufficiently robust and thus recommends to provide confirmation of effectiveness with a second phase III trial.
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