Timothy Mayleben
Management
Yeah. So, maybe I can give you sort of an overall sense. When we put this study together we worked with the leading KOLs and sites out there to develop a estimate for what – how many patients per site, per month we should expect, and you know, I think we also had an expectation going into the study of how long it would take to wrap after that. I think as we talked about both in May and in August we said there is a natural wrap to these clinical trials, but they are not – they don’t start out at a 45 degree angle from the start, thinking about an upward slope in line that they tend to be adding some tie back, in a sense that they start out low and then ramp up quite steeply that they – slope of the line of the enrollment graph, if you will, gets steeper over time. Both as the sites get more familiar with the protocol and identifying patients, as well as I think as you highlighted the increase in the number of sites. We continue to add sites to answer that question I think we’ve got about another dozen sites that we’ve added over the last three months or so that are working with us and we expect that to continue to increase, and then from there again we won’t get into all the specifics because I think as we mentioned on the last call, there is a level of granularity here for competitive reasons that we don’t want to be – I guess to – two other folks that either are or may have ambitions to get into the space and to compete for patients if that’s their desire over time. So there is some information that we won’t be disclosing. Despite the fact that I know – Jason I know you and certainly others you guys are data hogs as much as we are data hogs, we love the data and we want to know more, we always want to know more. But having said that we set a goal for the sites on an average basis, again so many patients per site per month to enroll in this trial and that target, which again I won’t mention the specific number but I can say that we have a handful of sites that are at or above that number. But most of the sites have yet to achieve that target site per patient per month goal that we established. And that’s really the key to the success of this trial. So, most of our efforts in the last two or three months and over the next several months will really be devoted to taking the sites that are active and getting them to that goal. Getting them at or above that goal of enrolling patients. Because we can continue to add sites – just to help you understand the logic, you know, we can continue to add sites for ever, there is a cost of that, but unless those sites are performing at goal then we are not getting a good return on our investment there and we are certainly not making a progress in the study that we would like to see. I think the guidance that we have got – as you probably know, there haven’t been a lot of CLI trials that have been done, the guidance that we’ve gotten from those that have participated or led some of the prior CLI trials is that it takes nine months or so to get these studies performing or the sites in these studies performing at a high level and we hope and expect the next time that we are talking to you that we are talking about hell of a lot more patients enrolled in the study than what we are seeing now. Again we are, as I said, we are not satisfied, we are disappointed in the level of enrollment so far. But we are also trying to make sure that there is a whole lot of things that we could be doing but we really have the thing here focused on doing those things that are going to yield the best results. Again, because we don’t want to confuse activity with results. We want to make sure that any activity that we are undertaking actually produces a result, the result being, the desired result being significant and dramatic improvement in enrollment and that’s where we are focused.