More than 19,000 people have died from COVID-19 in the last 14 days in the USA and yet I am still hearing pushback on here about an additional Mesoblast Remestemcel-L COVID-19 ARDS trial in the USA ?
While I am the first to admit that SI & Co. need to find someone like the NIH or another large partner to fund it, it is obvious that the current regime of approved drugs and treatments for COVID-19 are failing these thousands of people each week or they wouldn't be dying in such large numbers more than 2 full years into this pandemic
With guidance like this from the FDA in relation to an EUA for Remestemcel-L, SI & Co. are bound to focus on the <65yo cohort in the next trial to ensure they show "statistically positive outcomes" using the breadth of data already obtained in the first trial like Biomarkers etc
https://www.worldometers.info/coronavirus/weekly-trends/#weekly_table
https://www.statnews.com/2021/12/14/califf-confirmation-hearing/
Califf sails through confirmation hearing for FDA job
I wonder what this guy will have to say on the whole COVID-19 matter as it continues to deteriorate again in the winter months of January and February throughout the USA
RWE for 2nd MSB COVID-19 ARDS P3 Trial, page-54
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