FDA approval chances and time frame, page-16

I'm on the same page.

My guess is that Ryoncil will be approved within two weeks from today, i.e. prior to Sept.

In that time, interim data will be sent to DSMB for Covid-19 ARDS.
DSMB will then deliberate that the trial can stop early due to overwhelming success, in early Sept
Then the FDA can extend the approved Ryoncil label for Covid-19 ARDS, pending manufacturing improvements.

That works best for me and it will be the path of least resistance for all concerned:

• FDA - well, we've followed a rigorous process. The product is safe and it works
• WH - this is led by the scientists
• Mesoblast - we've shared data with you, this product work and is safe for both kids and adults. We've also dealt with your issue on manufacturing, so can you fast track the approval of this new method of production? The last bit (manufacturing improvements) is challenging and will take a bit of time, but there will be pressure from the WH to fast track it.