We’ve also uncovered data that suggests that these are very critical, the ability to modulate these pathways are very relevant in the clinical outcomes that we observed in this trial.
Jason McCarthy: Can you address also the floor effect drove in part the 28% or so placebo group response rate in the total population in the Phase 3. You had mentioned in the 106-patient data that was presented a couple of weeks ago at the Muscular Dystrophy Conference where the — you remove the floor effect and the placebo response was 23%, while NurOwn was — I think you said 40% or higher. The 23% was still above that 15% statistical benchmark that you designed the trial around? Is that a function of something else or is that just the small end value in a subgroup that created some noise and it looked a little bit higher than that 15%?
Stacy Lindborg: Yes. I mean, so I would say that, that is within the ballpark of what we expected based on historical data. So when we design trials, we look at historical data and we really try to estimate based on other studies in other settings, natural history and also clinical trials. And given the heterogeneity of the disease and the progression rate, all of that can basically interpret and lead to findings and trials and you really try to estimate what would you expect in a group of participants randomized to placebo. So the primary endpoint in the assumption that we see about a 15% response rate on the placebo arm, a 35% response rate on the NurOwn treated participant arm. Those were our assumptions going into it. And in this sample of about half of the data, the NurOwn responders were also about 5% higher than what we anticipated going in, so it’s 40% — 41% and placebo around 20%.
So I mean these are — we were expecting it’s about a 20% difference in the response rate and we see that in the sample. And I would say that when you take small samples, you expect some variability to consume
Jason McCarthy: So the last question briefly, can you just talk a little bit about the safety aspects of an autologous cell therapy being incredibly safe. I think it goes relatively unnoticed when everyone’s focused on efficacy versus other types of therapies? And how something that’s very safe like this could really impact to the good an ADCOM decision?
Stacy Lindborg: Yes, that’s also a great question. And with every single study, we take very seriously the safety of the trial participants and we monitor safety very closely. We had a daily safety monitoring board, monitoring the patient safety lives across the study. And we also go to great links to summarize what was observed in a trial, so we can certainly talk hypothetically as you’re asking about the anticipated safety in a — with a autologous cell therapy. But what’s important is to also come back to the evidence and what we generated. We’ve summarized that very completely, very thoroughly and certainly that will be summarized at our ADCOM. This is a dimension that the physician’s closest to our trial, including our Data Safety Monitoring Board, have continued to express that there were no safety concerns, that were existed in the trial or that emerged as a — from a profile of NurOwn and that safety has been clarified to their complete satisfaction.
Jason McCarthy: Great. Thank you for taking all the questions.
Chaim Lebovits: Thank you, Jason.
Operator: Your next question for today is coming from David Bautz at Zacks Small-Cap Research.
Chaim Lebovits: Thank you.
David Bautz: Hey, good morning, everybody. So, Chaim you’re going to have ADCOM date soon or PDUFA date soon, so when does the company begin discussions say with third-party payers and maybe discussions about patient access. I don’t want to get too far ahead of things, but at what point did the company begin to have those discussions?
