RE:RE:Additions to Study DesignThese lengthy additional surveillance times were never part of the original or even the optimized trial. It is important to remember that accelerated approval is now only granted with a plan in place for additional confirmatory surveillance in single arm trials. 60 months sure fits the bill for an additional surveillance plan under AA. I'm not saying that AA is just around the corner, but this change in the design of the trial lays the foundation for it sooner rather than later. I view it as maybe a positive directive from FDA