Left-e was able to sum up todays thoughts for me quiet clearly. I Thought it a good idea to share on the HC board.
Thanks Left-e.
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Left-e, 2 hours ago (Yahoo Finanace Board)
The 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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