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FDA reply to BII IDE

January 23, 2002 8:00 AM UTC

Biocompatibles (LSE:BII) said the FDA raised questions regarding BII's Investigational Device Exemption (IDE) filed in December 2001 to start BATMAN II, a pivotal trial of its batimastat coated BiodivYsio stent to prevent restenosis following coronary angioplasty. CEO Crispin Simon said, "most of the questions relate to preclinical, physical testing and the clinical protocol, as the FDA has never been asked to approve batimastat on a stent before." BII expects to resubmit its IDE in the next two months. ...