banter and General Discussion, page-8350

@irenekwshiu
This is my understanding, and happy for it to be corrected.

I think the FDA are looking at a few aspects, in particular a balance between clinical evidence and potency assays

For GHVD pediatric, most of the data is based on study 001, which is a single-arm trial.
Given that scientifically, single-arm trial data are weaker evidence than a RCT - the FDA then puts more emphasis on the potency assay.
That's where we are with Rex-L (Ryoncil).

But, for CLBP and CHF, mesoblast have conducted RCTs - so, I would take it that as long as the RCT data is good the FDA would require less from these potency assays for Rex-L when compared to Rem-L (Ryoncil).