This article was originally published in The Gray Sheet
Firms restructure their previous marketing agreement for VimRx Pharmaceuticals' Isolex stem cell selection system, including either a $20 mil. line of credit from Baxter or assistance in a larger private placement financing. The modified agreement transfers marketing responsibilities to VimRx subsidiary Nexell Therapeutics, while Baxter retains contract manufacturing, physical distribution, placement and service responsibilities. In January, a PMA for the Isolex 300 stem cell selection system and a PMA supplement for the fully automated Isolex 300i were deemed "approvable" by FDA, contingent on the submission of more information for labeling and inspection purposes. The information has since been submitted, and VimRx is awaiting final approval
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