Ascelia Pharma receives positive feedback from FDA on design of the pivotal Phase 3 study with Mangoral®

Ascelia Pharma AB today announced that the company has successfully concluded discussions with the US Food and Drug Administration (FDA) regarding the study design for the single pivotal Phase 3 trial for Mangoral® as a contrast agent in patients with focal liver lesions and severe renal impairment.  Ascelia Pharma will now complete the preparatory work to start the trial and expects to enroll the first patient during the second half of 2019.Mangoral® is an oral contrast agent for liver MRI developed to facilitate the visualization of focal liver lesions, including liver metastases, using