Comment by Arlene Hubbard 1 hour ago Delete Comment

Tony,

FDA update:
The Hubbard Foundation Registry is IRB approved and we have requested an FDA exemption and are scheduling a phone conference with them. Our IRB documentation is complete and correct. The FDA may or may not request changes. We are waiting to hear. 
We had a phone conference with Vascular Access Centers and it is our understanding that they will continue to collect follow up data on patients already enrolled and are withholding enrolling new patients pending the FDA exemption.
We'll keep you posted on any new information.