Isolex PMA Approval Based On Surrogate Endpoints Defended By Nexell
This article was originally published in The Gray Sheet
Executive Summary
Approval of Nexell's Isolex 300 magnetic cell separator system based on surrogate endpoints is a "logical follow-up to the issues and concerns that came from "panel review of CellPro's competing system," Nexell writes in a March 18 response to a CellPro citizen's petition to the agency.