https://www.mesoblast.com/images/pdf/MSB_2019_Annual_Report_AR_AS...

https://www.mesoblast.com/images/pdf/MSB_2019_Annual_Report_AR_ASX.pdf

again....ITS ALL ABOUT MANUFACTURING.

page 20.
"Before we can begin commercial manufacture of our products for sale in the United States, we must obtain FDA regulatory approval for the product, in addition to the approval of the processes and quality systems associated with the manufacturing of such product, which requires a successful FDA inspection of the facility handling the manufacturing of our product, including Lonza’s manufacturing facilities. The novel nature of our product candidates creates significant challenges in regards to manufacturing. For example, the U.S. federal and state governments and other jurisdictions impose restrictions on the acquisition and use of tissue, including those incorporated in federal Good Tissue Practice regulations. We may not be able to identify or develop sources for the cells necessary for our product candidates that comply with these laws and regulations. Further, we may be required to conduct additional clinical trials using 3D manufacturing processes before we receive regulatory approval."

The mythical "ready to go" 3D dream machine Barman claims is all ready to go.....LOL