Rezolute Said FDA Is Still Reviewing Ersodetug Submission In Congenital Hyperinsulinism; The Company Continues To Await Feedback And Reserves The Ability To Request Formal Meeting Under Regulatory Timeline
Data from the Phase 3 sunRIZE study remains under review by FDA The OLE Phase of the study is ongoing, with a high participation rate and several indicators of improved glycemic control, including a notable reduction in
Rezolute is waiting for the FDA to finish checking their medicine for a rare condition where kids make too much insulin. The company is still gathering more patient information and can ask for a meeting if needed to speed things up.
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