Schering AG/Epix' Imaging Agent Requires Additional Clinical Studies, FDA Says
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA requests further clinical studies for MS-325 (gadofosveset trisodium) to demonstrate efficacy, the "approvable" letter states. The outstanding questions relate to the non-contrast comparator scanning methods used in Phase III trials and the statistical treatment of uninterpretable baseline scans.
You may also be interested in...
Epix Considers Selling Vasovist If Imaging Agent Clears FDA
FDA agrees to accept a “blinded re-read” of data on the vascular imaging agent as an NDA amendment after Epix appealed “approvable” requests for more studies.
Epix Considers Selling Vasovist If Imaging Agent Clears FDA
FDA agrees to accept a “blinded re-read” of data on the vascular imaging agent as an NDA amendment after Epix appealed “approvable” requests for more studies.
Epix Pegs Vasovist Approval In Second Half 2007 Following Second “Approvable” Letter
FDA’s action letter for the vascular imaging agent requires an additional clinical trial and a re-read of images from previous trials.