John Hester: Good morning, Silviu. I want to refer back to your prepared comments. There, Silviu, we discussed about your intention to provide additional data on potency to the FDA. It sounded to me like you were leaving the door open there with respect to their recent decision. I believe you said that you were hoping to show additional data to prove the potency of the current product relative to what was used, the product that was used in the pediatric study from several years ago. Can you just confirm I understood that correctly and what exactly do you mean by those comments and what do you hope to prove?
Dr. Silviu Itescu: Well, that’s exactly right. The primary reason for the CRL was that the FDA remains wanting to be convinced that the product in our current inventory that is to be for commercial launch is substantially the same as the product that we’re using in the Phase 3 trial. And our potency assay needs to be substantially the same potency assay as was used in the Phase 3 trial in order to demonstrate that the two products are the same. We have those data that are currently being developed. Some are in place. Some still need to be added. We expect that in the next few months we will complete those data. And that is part of the discussion of the upcoming Type A meeting. Perhaps, Philip Krause could add some color to my comments. Philip?
Dr. Philip Krause: Sure. I will make a quick point here and that is the CRL had, although, of course, the disappointment of being a CRL, but had two positive indicators in it as well or two significant positive indicators. One of course was the favorable results of the inspection, but the other important thing to take note of is that, the CRL did not question the efficiency of the product as was demonstrated in GVHD001, as had been the case in the previous CRL. But the CRL did continue to question and raise questions about the potency assay. And specifically, the characterization and standardization of product that went into GVHD001, and then the ability then to make future product that was similar to that, which went into GVHD001.
And so, this leaves open the real possibility that by using exactly the same assays that were used to characterize the product going into GVHD001, for a new commercial product that it would be possible to show that the new commercial product is similar enough to that, which was shown to be effective in GVHD001. Now, the CRL then went on to say that, if that can’t be accomplished, in other words, this demonstration, then the only way forward would then be another clinical trial in either adults or pediatrics, which would then allow this connection between potency assay and clinical outcomes to be made, and thus allow future product to be related to product that was shown to be effective in a clinical. So, maybe I will stop there, but could take a follow-up to previous one.
John Hester: Maybe just one follow-up Mr. Silviu, if I may. What are the fundamental changes between the product that was used in the 001 trial and the product you were now attempting to have registered?
Dr. Silviu Itescu: I can address that. There were no changes. The same exact manufacturing process and the same product went into the Phase 3 trial as it’s currently in inventory and intended for release. And that’s really what the inspection of the process and the plant and ultimately concluded. So, there are no changes to the product. What we need to ensure is that, we have a potency assay in place that was used precisely in that Phase 3 that continues to demonstrate the same attributes of the existing inventory. Phil, would you add anything to that?
Dr. Philip Krause: I would not. I think that’s exactly right. The manufacturing process has not changed.
Operator: Thank you. That brings us to the end of today’s call. I will now hand back for closing remarks.
Dr. Silviu Itescu: Great. Thank you everybody for joining us today. We hope that we have been clear in providing details around our interactions with the FDA our upcoming Type A meeting, our focus on finance and cost reductions, managing our cash runway and laying out the upcoming milestones on some of our most important products and whether value proposition is for our shareholders. Thank you very much.
Operator: It does conclude our conference for today. Thank you for participating. You may now disconnect.
