"I would be interested to know peoples thoughts on whether they think the outstanding CMC issues for Rem-L outlined above by the poster is the main reason why the next COVID - ARDS trial has not progressed in any meaningful way...."
I think its clear from MSB's own announcement that the FDA won't allow the ARDS trials to resume without first sorting out the potency assays (which are CMC issues).
See November 24, 2021, Operational Highlights and Financial Results for the Period Ended September 30,2021, page 2
Under heading - "Acute Respiratory Distress Syndrome (ARDS) due to COVID-10"
..
(at bottom of page)
"FDA indicated that potency assays must be established and agreed prior to commencement of the proposed Phase 3 clinical trial".
BLA resubmission for children with SR-aGVHD, page-6
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