Ascelia Pharma AB: NDA 220544

©) images to pre-contrast images alone for both lesion contrast and lesion border delineation co-primary endpoints.

The post hoc re-evaluation of images from ASC-Man-P016 was not adequately justified and may have introduced bias in the training of the new readers due to knowledge of the images and initial read results.

Thus, the re-evaluation of ASC-Man-P016, which initially did not achieve its pre-specified success criteria, is not considered to be adequate and well-controlled.

In the absence of a successful adequate and wellcontrolled study, substantial evidence of effectiveness has not been demonstrated.

As described in our General Advice letter dated June 11, 2026, we anticipate that, if this application is approved, you may be required to conduct a postmarketing study to identify any unexpected serious risk of exposure to {//)/" ) in breastfed infants.