Coupla things here.
First, the trial sponsor was Mt Sinai, not NIH. NHLBI (part of NIH) and Mesoblast were collaborators. So we should not endow the analysis with the NIH magic dust.
Multiplicity certainly applies - and regarding your comment "based on MSBs previous trials, we can safely assume multiplicity was taken into account" - we cannot safely assume anything of the sort. Indeed history tells us this company regularly reports descriptive p values and without correction for multiplicity.
Finally, continuing the history of this company, we can safely assume that this is just the latest in a long line of clinical trials which failed to meet its primary endpoint (day 30 mortality). We know this because, had we achieved it, it would have been reported. Indeed it is a fundamental ASX reporting requirement that the result of the primary endpoint be reported (along with all other details including number in each group, secondary endpoints, etc). MSB has a history of not reporting primary endpoints.
No wonder the ambulance chasers are racing up Collins Street!
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Ann: COVID ARDS Trial Topline 60-Day Results, page-576
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