Miles White
Analyst · Barclays. Your line is open
Yes, I'd say a couple things Matt. First of all let me back up and give a bigger context to this. Over the course of the year, there was a lot of scepticism on the part of analyst end or investors about all the things that we had to get accomplished, that were back end loaded. A lot of third quarter, fourth quarter things and depending on how you're looking at it, it looks pretty daunting and we all know everything doesn't go right. And the Sylmar inspection put some of that in doubt. Now having said that, we stuck to our guns on what our estimates were and our projections were about when we would get product approvals and claim approvals, licensure approvals and so forth. And the third quarter alone here has been pretty gratifying in that. We basically got every approval we forecasted and let's call it, within 30 days or so of what we forecasted and I think that's been pretty gratifying, that what we said is what happened and that includes Libre, that includes the high voltage MRI claim, that includes HeartMate, it includes the closure of Alere, it includes Libre, it includes lot of things. I don't generally like being backend loaded because it feels like a lot of risk that everything has to go right, but everything did. And our progress with Sylmar is no exception as I've indicated on prior calls. Our team that has been working with the Sylmar team and so forth has done an exceptional job that we have provided all information, taken all actions, done all remediation, everything basically done on time, delivered to FDA, discussed with FDA etc. And at this point and we're just experiencing those new systems populating with new experience, new data, new decision making etc. and all of that is going exactly as planned, exactly as forecasted, exactly as communicated with the FDA and thus far without a hiccup and I think that's recognized by the FDA. I think it's recognized, they have discretion, they don't have to license new products out of that facility, but they have. And I think that is evidence of how we're progressing with Sylmar and the fact that the FDA is giving it all the scrutiny that they would and should and what we've submitted to them for approval has been given fair and objective consideration and we've gotten our approval so far. With that said, the remaining ones, I'm not going to change my estimates on. I'm not going to change what we forecasted. I have no reason to believe otherwise. They clearly have the discretion not to, but that's not been our experience and so consequently I remain optimistically that we're on track that we'll deliver what we said.