Ann: Mesoblast Q3 Financial Results Webcast, page-191

I'm using Learning text to answer you. That sentence you wrote "Now think about the trial for AGVHD with the kids!!!" ..."The FDA saved the kids!!!!"

shows u level of literacy its pretty high, isn't it ?


The FDA is more concerned about totally uniform batch consistency and reproducibility rather than the 70-90% mortality rates for a treatment for an unmet need ,which their review team has accepted, has no safety concerns. To quote Philip Hoffman, Chairman of the ODAC committee (page 194 of the transcripts) i voted yes (to Remestemcel) because i found “the clinical evidence compelling”. Many of the ODAC committee pointed out the horrendous toxicity profiles of competing treatments that showed no real efficacy. The FDA has 309 case studies of children showing Mesoblast can deliver a consistent product

CATO