Joe Pantginis: That’s really helpful, thank you. And then just switching over to OPC1was hoping to get even some broad strokes at the minimum. the types of questions that have been going back and forth between you and the FDA and how that’s translated into what your wish-list looks like going into the type B meeting?
Brian Culley: That’s a great question. I would say that the vast majority of the content in the materials that we’ve been sharing with FDA and the questions they’ve been coming back with have to do with the new device. This is a device that has not been used before for this purpose. And so they have a lot of questions about how it will be used and how it will perform. What provides us with some comfort and confidence is that the components that actually go into or touch the patient are the same. The, the cells that are being used are the same as before. The needle is the same type of needle. Everything that’s different with the nerve gain device is actually external to the patient. So I think from a performance perspective, I feel confident that we will have a, a good outcome from this study.
But nevertheless, the FDA is going to be prudent and want to understand, how, how do all these manipulators work? How do they attach, what happens in a fail situation? What’s the worst case scenario? Very standard types of information seeking questions that we’ve been getting.
Gary Hogge: And I’ll ask Gary if there’s anything that he, that comes to mind that he’d like to add to that question, Joe? Yeah, just, just add to that, there’s nothing unexpected, but many of these are first time in human use when the assembled together is an entire component. And so they, they want demonstration of if you pass the cell through, is it still viable and potent once it goes through the needle and syringe, are the components are the, what’s the pH of the components, what’s the software look like? They’re all questions that we’ve got to address. Many of them involve very complex, detailed reports and analyses, and that’s what the back and forth questions have been. Nothing unexpected, but many, much of it takes time.
Operator: Our final question comes from the line of Jason McCarthy from Maxim Group. Please proceed.
Joanne Lee: Hi good afternoon. This is Joanne Lee on the call for Jason. Thanks for taking the questions. Just two around OpRegen. My first one is regarding the recent approval from s which we noticed was purely based on disease trajectory with no benefit on visual acuity. Now that we’ve seen willingness from the FDA to prove based solely on structural changes in geographic atrophy does the upcoming data at ARVO take a greater importance for operation and how does this impact the importance of also demonstrating functional benefit in patients with ?
Brian Culley: Thank you for the question, Joanne. I think that the ARVO data is going to be important because there will be parts of that data that have not been shared before, and we’re working with a product candidate that is being discussed as being capable of, of creating anatomical changes far beyond that of the, the leading candidate and the more recently approved complement inhibitor. So I think any new data on our approach is definitely meaningful to the field. With respect to the second part of your question, how does it change the, the calculus on function? I think it’s notable that the data from that, recently approved asset essentially proves with statistical significance that they do not affect the visual field.
So I think that the opportunity to provide a greater clinical benefit in patients is sitting there for the taking for whichever approach and whichever company can find it, because the standard of care clearly has unquestionably, has no effect on visual function. So I, I see that as great opportunity and I think that we are one of the most important contenders to grab that opportunity.