A bit old but I thought in case nobody else has shared already, it's useful.
"The potency assayfrom the 54 patient paediatric study completed in 2020 has been the subject of intensescrutiny by MSB who now believe they have resolved the matters which led to thevariability in measurement of batch potency.It was this discovery that led to the FDA to request the company to re-submit the BLAapplication (March 2024)."
banter and General Discussion, page-10871
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