Mesoblast CC Transcript 31/8, page-51

Good question.

I think it goes back to the original CRL#1 - batch to batch consistency. How well has this been proven for the first allogeneic MSC?
You'll find a few references in the transcript above, but that is how I reference it - the FDA put the onus on Mesoblast to prove the batch to batch consistency with data.

To me, FDA are unsure how to deal with the first allogeneic MSC product - and are creating big hurdles for Mesoblast.

Also, I just don't see the mechanism for FDA approval, apart from an AA - which requires the adult trial to be active and meet some conditions X - where X is to be further discussed/ agreed with the FDA during the Type A meeting...

Or maybe, Mesoblast may be able to provide sufficient data to clear CRL#2 and we'll get full approval for Ryoncil for kids

Arghhhhh - why are we having to guess all the time?
Mesoblast, do better with your comms and explain the situation in plain English!!!
The next opportunity is upon the response from the FDA on this Type A meeting - do better Mesoblast!