I have a problem with Rosa being pleased with the lack of...

I have a problem with Rosa being pleased with the lack of progress, enthusiasm and speed ? certainly not speed ? the IRB process has obviously delayed sites getting up and enrolling again , IRB take their own time and is not in Rosa's control , lets hope we continue implanting and SSH continue releasing good data results ensuring a FDA approval sooner , it would be un ethical to withhold a treatment from the standard of care arm if in comparison the C-Pulse implanted patients are doing so well, all trials have that provision .