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Ann: DSMB Recommends Continuation of Phase 3 COVID-19 Trial, page-236

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    Mesoblast secures ethics approval to treat COVID-19 patients in Australia

    Sep. 02, 2020 2:24 AM ETMesoblast Limited (MESO)By: Mamta Mayani, SA News Editor2 Comments

    • Mesoblast (NASDAQ:MESO) has received approval from the Human Research Ethics Committee of Monash Health to include Australian hospitals in the Phase 3 trial of remestemcel-L in ventilator-dependent COVID-19 patients with acute respiratory distress syndrome (ARDS). Up to 300 patients are expected to be enrolled in this late-stage study.
    • The clinical protocol was based on results from a study using remestemcel-L at Mt Sinai Hospital in New York, with 75% (nine of 12) of patients successfully taken off a ventilator and discharged within a median of 10 days.
    • The primary endpoint of the Phase 3 study is all-cause mortality within 30 days of randomization, with the key secondary endpoint being the number of days off mechanical ventilator support.
    • The trial’s independent Data Safety Monitoring Board plans to complete an interim analysis this month in the first 90 patients randomized in US after they have completed 30 days of follow up.
    • See Meso's developmental strategy for remestemcel-L:

    • Mesoblast has shown exponential growth of around 290% over the past year. Both, Quant and Wall Street Analysts Ratings are Very Bullish with price target of $22.00 and Momentum Grade of A+.

    • Yesterday's close was $18.95. Shares up 2% after-hours.



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