We don't know about the 30 day readmissions for HF. Going from...

We don't know about the 30 day readmissions for HF. Going from the feasability trial and the German experience this is around zero for the implant arm. The four deaths suggest we are implanting the desperate class 3 and 4's who have already been hospitalised once within 12mths, which suggests the re-hospitalisation rate for HF at 30 days in the control arm would be very high. Is the FDA "out" of it till the interim look? I suspect they are, what sort of data has the company supplied?