Ann: Latest Patient Group Show Best Results to Date at 30 Days, page-61

The delay is likely at the medical facilities that are running the trials themselves as the FDA has approved the trial. Each facility has to approve the trial internally then identify and enroll patients so that takes time especially with a trial that is implanting a life-sustaining device. All the t's have to be crossed and i's dotted before the first patient can be implanted and liability protection probably needs to be more robust in the US than in Georgia.

The caveat is that if Eire is correct and valve-in-valve procedures will be included, that likely adds more bureaucratic approval probably both on the FDA and individual site levels and may be why Wayne only promised at the AGM that 30-day data would be ready for the TCT Conference in late October.