Ann: CEO Presentation to 2023 Annual General Meeting, page-68

A bit more explication of the potency assays was good, makes sense. Also clarified that FDA only needs an RCT for aGvHD when there is no existing approved product - so RCT was not required for kids aGvHD, as there is no approved product for kids who have failed steroid. It was totally an issue with variability of results from the potency assays - not variability of the stem cells, but a problem with the actual potency assay causing variability. Potency assay was re-done for the trial, but needs to be re-done for the inventory and should be able to show that the cells are well characterised (because manufactured by the same FDA approved process) and should be approvable once this is agreed. No commentary on whether they can get a Class 1 or Class 2 resub, but some commentary from a friend chatting to SI afterwards agrees with my view that a Class 1 is a good chance (ie 2 months review). So could still get a decision by end March (maybe).Adult trial may not need RCT if they go for people who have failed Rux as well as steroids - no approved product once you have failed both. Will have a meeting with FDA pre trial to discuss this. As I've said before, if FDA requires an RCT, Meso will do one. It isn't a big issue.

Aloha.