Cell Therapy News/Articles, page-10194

  1. 126 Posts.
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    That's exactly my point, you're trying to argue your speculation is right and everyone else's speculation is wrong. All we can go off is the facts.

    The facts are in patients <65 who had ARDS:
    • Rem-l reduced 60 day mortality by 46% (p=0.048)
    • Rem-l reduced 90 day mortality by 48% (p=0.038)
    • Rem-l + dex reduced 60 day mortality by 75% (p=0.006)
    • Rem-l + dex reduced 90 day mortality by 77% (p=0.0037)
    • survival benefits were accompanied by significant improvements in ventilator-free days, respiratory function as assessed by ARDS severity, and overall clinical improvement on a 7-point ordinal scale
    • Dex alone provided no survival benefit in control patients

    Mesoblast have indicated that they had a meeting with the FDA and so we should expect the formal outcome of this meeting within 30 days (by 30 August).

    https://hotcopper.com.au/data/attachments/3420/3420790-10de696678a0ad463d0822dba67258e5.jpg
    https://hotcopper.com.au/data/attachments/3420/3420793-2a64bd764ba595ea373641616d91d34c.jpg
    https://hotcopper.com.au/data/attachments/3420/3420796-ad6970a46a2e59cd39d562fcf9607344.jpg

    To illustrate the power of this treatment, let's look at how many patients <65 have died in the US from COVID-19, 124,396 so far. If this was to happen again in the future Rem-L + dex has the power to reduce this by 77%, saving 95,000 lives.

    https://www.statista.com/statistics/1191568/reported-deaths-from-covid-by-age-us/

    Additionally, let's look at all cause ARDS in the US, causing on average 67,719 deaths in <65s annually (before covid). If Rem-l + dex has the same effect in all cause ARDS, then it has the potential to save 52,000 lives every year.

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5122485/

    Noting that no treatment has provided a significant survival benefit in any patient population for ARDS. I don't know how Novartis could walk from this given the huge potential of the all cause ARDS market.
 
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