“So we do remain confident in donanemab and believe that TB-2 and our overall TRAILBLAZER program have extensive data and so as we review the requirements in the NCD, we believe our data should be sufficient to meet the high level of evidence criteria set forth by CMS if TB-2 as positive.”

In context

“udies in the competitive landscape there in obesity, and then Anne for the question on the NCD in the donanemab. Mike Mason: Yeah. Good question. We touched on this a little bit early, but I think, the -- we expect the Step CV study to be successful given the expected weight loss and what he has expressed. We think that will be important to continue to grow the class and for some payers winning access on it. So we hope that the Step program is successful, we expect it will be, and obviously, we have a very comprehensive Phase III program to demonstrate outcomes for obesity, we also are confident in. Kevin Hern: Thanks, Mike. Anne? Anne White: Yeah. Thanks for the question on donanemab. So, as Dan mentioned, our priority will be to advocate for reconsideration with the TB-2 Phase III data. So we do remain confident in donanemab and believe that TB-2 and our overall TRAILBLAZER program have extensive data and so as we review the requirements in the NCD, we believe our data should be sufficient to meet the high level of evidence criteria set forth by CMS if TB-2 as positive. Obviously, we will need to review this data with CMS and gain their agreement. So we will do that very quickly. Our intention is as soon as we have that data to request reconsideration for national coverage and we believe that having two positive pivotal trials should meet that high level of evidence. As far as CMS, we have engaged with them throughout the process and so we will continue to do so moving forward. And there’s a number of statements in the NCD that we will see clarity on to gain additional clarity as we move forward. But, yes, we do believe that we should meet that high level of evidence, but pending those discussions with CMS. Kevin Hern: Thanks, Anne. Chris, thanks for your questions. Next caller, please. Operator: The next caller is Robyn Karnauskas from Truist Securities”