https://finance.yahoo.com/news/mesoblast-limited-nasdaq-meso-q4-121435104.htmlHi JB- link as requested- I listened to that call- Phil Krause used the word efficacy- it has been transcribed as efficiency. If you note that he refers to it being part of the first CRL not the second. I jumped at that news- huge.
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.
(20min delay)