The CRL is consistent with the preliminary feedback Cosmo announced on May 9, 2018, stating that the FDA identified unspecified deficiencies that preclude the continuation of the discussion of labeling and post-marketing requirement/commitments. The CRL states that the FDA has determined it cannot approve the NDA in its present form and provides recommendations needed for resubmission.
The FDA did not raise any safety or manufacturing concern. The CRL states instead that, although the outcome of the phase III trial has translated in a statistically significant outcome, the outcome is not sufficiently “robust” and thus recommends Cosmo to provide confirmation of effectiveness with a second phase III trial.
Cosmo Pharmaceuticals CEO Alessandro Della said: "We are extremely disappointed for all patients looking for more effective colonoscopy and we strongly disagree with the FDA conclusions.
"This decision fails to consider the benefit-risk of Methylene Blue MMX and the high unmet medical need. We believe the concerns raised by the FDA are fully addressable, thus we will work to have a meeting with the FDA as quick as possible.“
Cosmo does not expect its guidance for 2018 to change at this point in time because, whilst there might not be Methylene Blue MMX revenues in this year, there also won’t be the associated product launch and sales force costs.
Source: Company Press Release.