I would be suspicious that SI hasn't told the full story here.If what you're claiming was true then I guess you would have to say the same thing about Dr Krause as well ? ..... he's had a bit to say publicly as well since the CRL so why stop at SI ? Sounds to me like you're making slanderous comments about the officeholders of a listed ASX company but hey whatever makes you happy
https://hotcopper.com.au/threads/mesoblast-cc-transcript-31-8.7562026/page-2?post_id=69663727Perhaps, Philip Krause could add some color to my comments. Philip?
Dr. Philip KrauseSure. 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 HesterMaybe 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 ItescuI 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 KrauseI would not. I think that's exactly right. The manufacturing process has not changed.
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