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Extract regarding label extension of adult refractory GVHD that...

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    Extract regarding label extension of adult refractory GVHD that Analysts arent accounting for....

    Mesoblast (MESO) CEO Dr. Silviu Itescu on Q4 2018 Results - Earnings Call Transcript

    Aug. 29, 2018 11:28 PM ET

    Michael Gerges

    Just firstly on GVHD, it seems logical to me that the opportunity for label extension for MSC-100 to the chronic and adult market. I’m just wondering if that's something you’re considering and whether there’s a similar market opportunity that exists there, and then perhaps a little bit difficulty into penetrating that market?

    Dr. Silviu Itescu
    Look, I think you’re absolutely correct. And I think that’s part of our discussions with the FDA. How to think about a post-marketing study in adults that will allows appropriate label extension and generate the kind of data that both the FDA and payers as we want to see an adult. That also applies to much of the U.S. but to Europe.

    Michael Gerges
    In terms of the market opportunity that exists, but from perhaps on an economic standpoints in a therapeutic offering standpoint, is it the same as what we see in the pediatric market?

    Dr. Silviu Itescu
    Developed market is probably three times the size of the pediatric. Pricing per patient, again, when I say three times of size, we would be targeting again the most server form of the adult disease, right. So, it will be patients who are otherwise refractory and who have no alternative. So, it's a same sort of logic, but the market opportunity is threefold.
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