So as recently as December 14 2021 Mesoblast reaffirmed previous advice in previous ASX announcements to the market of its intention to undertake an additional pivotal phase 3 COVID-19 ARDS trial to support an EUA application.
Sadly since then the COVID-19 situation in the USA has deteriorated even further week on week with the average daily death numbers now sitting back above 2,000
https://www.nytimes.com/
Almost 9,000 people have died in the last 3 days from COVID-19 in the USA even with all the current drugs and treatments available so why is it taking so long for this pivotal phase 3 trial to begin ?
Is funding the problem ?
Are the NIH not interested in funding another trial based on the results of the first one ?
Is SI struggling to find another partner to fund this 'pivotal' trial for COVID-19 ARDS ?
Are they waiting for the 12 month results from the first trial to bolster support from a funder ? (these should be with them soon given the original trial stopped dosing patients in December 202o)
More questions than answers unfortunately but IMHO there is merit in undertaking this additional COVID-19 ARDS phase 3 trial using Remestemcel-L for <65yo's as these numbers of people dying each day are just unacceptable
https://www.worldometers.info/coronavirus/
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RWE for 2nd MSB COVID-19 ARDS P3 Trial, page-90
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