I don't know, I just think it worked out this way rather than a strategic play for COVID-19 ARDS, as there are a few other parties involved FDA, NIH, Hospitals, government, Lonza, patients... it would have been too hard to purposely slow them all down to get Mesoblast ducks lined up...
But, I've always believed that Rem-L for COVID-19 ARDS was always intended to be an extension of Ryoncil, as this was the path of least resistance for the FDA.
In terms of delays - well, if the CHF and CLBP readouts are not happening in the next 2 weeks, then it has been delayed - no ifs or buts. After mid-August, then it doesn't matter which definition anyone used, the mid-2020 us well and truly delayed by then.
So "upcoming" hopefully means next two weeks.
Also, no one wants to look like a doll - so for the DSMB to set an early Sept date, then they must have some reassurance that the 90 patients data will be provided to them by mid-August... so, the data could be released as early as next week
Exciting time to be an MSB'ers
Ann: COVID-19/GVHD Update, Quarterly Report and Appendix 4C, page-166
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