Mesoblast 2025: The year of acting like a publicly listed company, page-1162

AA would likely generate significant revenue, not hard to see $1 billion in revenue. 5 patients each over 40 centres, 50 weeks per year @ $100 000 . That is why rushing to secure a partner at this stage would be economical vandalism, like wise a CR . Some talk about a CR for manufacturing, perhaps but I would not bet on it. 3D has been achieved and several runs manufactured for comparison studies that are very similar. I would be very surprised if the AA meeting with the FDA is not asking about 3D and how to bring that technology to clinical use and approval. There may not be any reason for clinical testing before approval as the end product is very similar and obviously would pass the current potency assays.

If by good management and a lot of luck we get the all good for 3D the SP would leave the shorts in ashes..

Then we could get the go ahead for 2D only. Leaving 3D to development trials perhaps either as a stand alone trial or as a arm to the confirmatory study. Shorts may get a win as manufacturing will need ramping up or perhaps a partnership.

Then at the bottom. To hard at this stage, perhaps rejection on potency assays . Not likely but we are talking about the FDA. In this case shorts will be relieing on a pull back of the SP. I would not expect any thing to significant as instos will be buying. The company by simply announcing that they will be focusing on GVHD and CLBP is in a very strong position. Building sales on GVHD could easily fund a IBD program.

GLTA