Ann: Mesoblast Type A Meeting with FDA, page-15

“Mesoblast intends to generate in the coming months new potency assay data for RYONCIL showing that the product used during pediatric Phase 3 trial MSB-GVHD001 WAS standardized as to its identity, strength, quality, purity, and dosage form to give significance to the results of the investigation as described in the Code of Federal Regulations for adequate and well- controlled studies (21 CFR 314.126), and that commercial batches made for the pediatric indication will meet the same standard.”

Looks like SI is getting the sh*}s with FDA. Tired of getting kicked post to post.