Kevin Ronald Sayer - President and Chief Executive Officer
Management
Danielle, this is such a paradigm shift, I think they truly want to make sure we have the public panel and everybody can digest the information. As we've gone through this process, it's not only the MARD, it's overall patient safety and as we talk about simulations, for example, we built thousands, hundreds of thousands of used cases, where if the CGM reads, X and the finger stick reads, Y and the finger stick is right, but the CGM is wrong, what could happen or vice-versa. And what they wanted to see is how we protect patients. And in all cases and all reality, the best way to protect your patient is with the CGM, because if they make a decision, even if the CGM for whatever reason is off and you know about our accuracy and reliability, the only way you know, you've made a bad decision is with an alert or alarm. And so, with our alerts and alarms and with our system, we believe that's much safer than the decisions patients make today with only finger sticks. So we've had to simulate and build those cases and make sure we have a very strong actual data platform to build this on. So, when you're going to make a change this big, I think what the FDA looked at and said with all caution, we need to make sure, we get this out on the public and we proceed down the proper path. The accuracy issue is fine, the other thing that we have to approve and support and again our 505 Software is the best ever found for this, is outliers. You really want to eliminate outliers sensors more than anything else. And our system does that and we need to show that it does. And so, all those things are being considered by them. And listen, we're going to comply.