The FDA also approved PLC’s request to expand their investigation from the 246 patients conditionally approved earlier this year to 406 patients and eliminate the requirement for an interim study analysis to be performed. As a result of this and other changes, the study is no longer considered an adaptive study.
Mark Tauscher, president and CEO of PLC, said: “We are very pleased with the FDA’s full approval to the investigational device exemption (IDE) supplement we filed in February 2008 to study RenalGuard in the US.
“Full FDA approval of the IDE supplement is another major milestone on our path forward to commercializing RenalGuard in the US, and with its receipt, we are well-positioned to begin the trial with our targeted study sites, once we have the needed funding.”