Ann: Mesoblast Type A Meeting with FDA, page-94

I think shareholders are rightly concerned about this paragraph:

FDA noted that the lack of a suitable potency assay for the RYONCIL product used during the Phase 3 trial MSB-GVHD001 for the pediatric acute GVHD indication has prevented the trial from being considered an adequate study for the purpose of demonstrating substantial evidence of effectiveness required for a marketing approval.

This is more than what we previously heard from the company that we just need to show batches in the inventory have similar potency as the batches used in the trial. FDA indeed questions the standardization of potencies of the batches used in the trial. Basically FDA is not yet convinced that the batches of cells used in the trial have homogenous potency and the potency assay used in the trial was adequate.