Sarge, best answer I have is they are in talks with FDA and...

Sarge, best answer I have is they are in talks with FDA and European Regulator and consider it necessary to obtain approval. Have a read of this excerpt from the Q1 2020 Earnings Call Transcript:
https://www.********/earnings/call-...limited-meso-q1-2020-earnings-call-trans.aspx
"In terms of upcoming milestones, the last patient last visit of this Phase III trial at 24 months of follow-up is expected to occur this half with the primary endpoint being a composite outcome of pain and function in both 12 and 24 months. We are working together with our partner Grunenthal to obtain clearance from European regulatory authorities to begin European Phase III trial. And as I've mentioned results from both Phase III trials will be considered pivotal to support regulatory approvals in both jurisdictions.
Let's look ahead for the next 12 months. What are our major operational milestones by product candidates? Remestemcel-L for steroid refractory acute GVHD and other rare diseases, we will be providing updates on a regular basis on Ryoncil's priority review and PDUFA dates. If approved, we expect the US launch of Ryoncil to occur this year and we will expand the investigator-initiated clinical trials for chronic graft versus host disease and other indications. Revascor for advanced and end-stage heart failure will have data readouts from the chronic heart failure Phase III trial around mid-2020 and we will be initiating confirmatory trial in end-stage heart failure. For the back pain product candidate, data readouts of the trial are also planned for mid-2020 and we seek to obtain clearance from European regulatory authorities to begin a second European Phase III trial."