Good post TSJ. For perspective, neither CHF or Covid ARDS have "failed" IMNHO.
CHF: 60% reduction in mortality against existing standard of care - not a fail in anyone seeking to save a life's book
Covid-ARDS: stopped due to improvement in maximal care messed up the baseline for the study, so you couldn't get a meaningful result - but MSB and its "third largest pharma in the world" partner now get to dig into what the actual results were - and I bet those, show an improvement across a range of factors - including mortality.
I do think however, that MSB needs to improve its trial design. And Novartis can assist with that.
Now, from Yahoo:1 hour agoThe company set the highest bar possible for a primary end-point: 30 day mortality reduction. To demonstrate a reduction on that end-point requires a significant mortality rate in the placebo arm, which is not being seen with the current enrollment, so best to stop spending money on the current trial and re-evaluate. Improved mortality in the placebo arm due to external factors tells us nothing about the inherent qualities and benefits of rem-L. That will have to be determined by an analysis of secondary endpoints, now underway. The PR states both Mesoblast and Novartis are working on that together as the current trial continues without further enrollment. Certainly disappointing but all is not lost. Important to get this right for MIS in children and “long hauler” syndrome due to pulmonary fibrosis in adults. There's a lot of data to be analyzed in the 223 patients enrolled concerning secondary outcomes. Awaiting further analysis of all patients at 60 days (approx 1 month from now) and publication of data before over-reacting here. glta
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