Nexell Therapeutics
This article was originally published in The Gray Sheet
Executive Summary
FDA "approvable" letter says that the firm's premarket approval application for the Isolex 300 stem cell selection system and the PMA supplement for the fully automated Isolex 300i can be approved "subject to the submission of additional information needed primarily to finalize labeling and the inspection of manufacturing facilities," the VIMRx Pharmaceuticals subsidiary says Jan. 8. Upon approval, Isolex will be distributed by Nexell minority owner Baxter, which has been distributing CellPro's Ceprate stem cell concentration system since the firm declared bankruptcy in late September ("The Gray Sheet" Oct. 5, 1998, p. 13)