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Growing Confidence on COVID-19 Application, page-29

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    Yes the trial did not meet its primary endpoint of 30 day mortality reduction. However the FDA changed guidance for mortality endpoints in severe ARDS from 30 days to atleast 60 days. The subset population showed significant benefit of 77% reduction over 90 days with a p=0.0037, combined with significant improvements in respiratory function, ventilator-free days and clinical improvement on the ordinal scale. This is highly significant. So there is significant data supporting points 1, 2 and 3.

    As for point 4 can you please clarify what alternative approved treatments there are for moderate-severe COVID-19 ARDS that significantly reduce mortality? The only one I know of is Dexamethasone which still has a mortality rate of ~40%. Rem-L appears to compliment this, reducing mortality when combined by 77%. The question isn't on future potential therapies or treatments its about what is available now, of which none apart from dex significantly reduce mortality.
 
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