Ann: FDA Supports Accelerated Approval Pathway for Heart Failure, page-250

" I thought this question was about the assay for kids aGVHD... "

Actually, the question posed by @Blackkkkkkk was about what happens next, assuming the potency assay is 'good and accepted by the FDA'. Specifically the question was whether it could be a rolling review submission or whether a 3-6 mth (minmum) period necessarily would apply to the FDA's determination of an (assumed) BLA original submission for rex for CHF with LVAD.

Keep in mind that if MSB did delay filing any required component, in reliance on its rolling submission rights under RMAT, there could be consequences in terms of delayed FDA consideration of the entirety of the submission, viz (from SOPP 8401):


Hope this helps.

Cheers