FDA reply 22nd

Can the FDA come to a decision?
No wonder this is taking time.
The review committee, (probably envisaged under pressure from the FDA ) is a mechanism to better select candidates for the trial.
Pacemakers etc. have been around for many years, many product cycles etc and they have an around 30% failure rate.
If they can't "pick" patients in a closely related area after many years of experience it doesn't look good that doctors will be able to "pick", except in the broadest terms for C-Pulse.
Can the implant arm be "tidied up" of unrelated deaths? It would seem to rely more on statistical aberration of small numbers than doctor "picks".
I also suspect that the control arm is diminishing fast extrapolating from a 50% reduction every 2 months as seen in the prospective patients. Thus I suspect the control arm is another target of the FDA's. C-Pulse's market is the most sick of a very sick cohort. Again extrapolating from the Pacemaker etc. experience, good luck to the FDA if they have aspirations of "tidying" this up.
FDA caught between a rock and a hard place.