Ann: CEO Presentation to 2023 Annual General Meeting, page-18

The company had previously indicated that the FDA didn’t want the heart meeting while the GVHD application is ongoing. Maybe that’s just how they do things. Hopefully, if the potency assay data are good and there is clarity on whether an approval is forthcoming on the under 12’s the company can then ask for a meeting to talk about the heart data. They have more than enough to talk about, especially if the special ODD and RPDD designations for congenital heart disease have been granted by then. The LVAD and Dream-HF data plus Congenital Heart Disease data will be a good “bundled” agenda - enough to get the FDA to sit up, listen and do some hard work on their end to at least understand what they are looking at.

The fact that Dr. Levine from the BMT-CTN went to the Type A meeting in Sep would in my view have really helped provide context to the aGVHD application in terms of industry landscape - where it’s at in terms of development, and also what he saw as “very compelling” data (as referenced in the recent company announcement) for children. He would have restated what the experts on ODAC had stated in support of efficacy back in 2020, and I wouldn’t be at all surprised that his attendance was behind the FDA then issuing its draft GVHD guidance. To me it’s the clearest sign that the FDA is a lot more supportive.

Dr. Krause would of course have been behind some of the recent moves and continue to be helping to facilitate further progress.