Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-574

Well, yes however it appears it was not the data that was not enough, rather the potency assay.

It seems given the FDA are now not asking for more evidence it works from another trial, the extra data must be clearly supporting the efficacy.

And now they have " activated" the ILSRAplha assay as an assay, and provided all that data which was not previously provided, as it was previously decided not to use it as part of an assay matrix. Now they will, so they need to provide all the additional previously unsupplied data that supports it specifically in the role of an assay.