Like everyone here, I would be absolutely ecstatic if we could...

Like everyone here, I would be absolutely ecstatic if we could get an approval based on the FIH and EFS studies but I don't think there's any conceivable chance that will happen.

Edwards is running a 915 patient trial to get the updated version of its Sapien device approved and it's a revised version of an already approved valve. No way will the FDA let a novel valve take a shortcut.

The number 1 priority of the FDA is safety and these are life-sustaining devices so they are expected to show that they are safe by completing sufficiently powered trials, which require large patient populations.