I could be wrong in my thinking, but from memory ARDS trial (past and future) was interlinked with GVHD. The design of the ARDS trial was purposely done so that they could use that data for GVHD.
SI has already mentioned that the Covid-19 ARDS will undergo an expanded trial, perhaps they may get accelerated approval for GVHD, in conjunction with the Covid-19 ARDS trial, data from this trial, will be used for the final BLA / Approval submission.
Ann: Update on FDA Meeting for Remestemcel-L in Paediatric GvHD, page-102
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