Well we know that MSB has a very potent form of MSC product. One that the FDA has agreed that the potancy assay has improved , one that has achived efficacy in 001 and we now know that Takeda have a problem with there MSC product. IBD is a very big deal.
https://www.takeda.com/newsroom/newsreleases/2023/Takeda-Announces-Topline-Results-of-Phase-3-ADMIRE-CD-II-Trial-of-Alofisel-darvadstrocel-in-Complex-Crohns-Perianal-Fistulas/
We still have to give the FDA new data to confirm the current stock on hand is as good as the old stock used in 001. If we are doing comparison studies of the effect of our product on IBD organiods to prove ongoing efficacy we would also prove effect on IBD.
Thanks to @stanjupiter
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7779798/
Ann: Mesoblast Type A Meeting with FDA, page-463
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