BioCentury
ARTICLE | Regulation

GPC's painful day

July 30, 2007 7:00 AM UTC

FDA's presentations to last week's FDA advisory committee meeting on Orplatna satraplatin, and GPC Biotech AG's subsequent comments, suggest that the late-stage meltdown of the company's application for accelerated approval, as well as the surprise it generated among patients and investors, were the result of communications breakdowns.

GPC apparently failed to understand, and it certainly didn't publicly communicate, the high degree of skepticism that FDA had about the prospects for accelerated approval of Orplatna. ...