I've not seen any comments about this little hidden diamond here. WOOOOOHOOOOOOOOOOOOOO !!!!!!!!!! How do you like them Apples JB?
Dr Kurtzburg, in proving the data supports the potency assay is linked with survival, combined with Mesoblast now releasing they have established a new specification for release.
Dr Kurtzburg showed in the trial, that children treated with cells that in tests had more than the "median" IL-2Ralpha inhibition, also had a much greater improvement in survival at 180 days.
How much more???? 85% vs 69% with all remestemcel recipients, vs 49% survival in controls So..... if Mesoblast have just upped their specification for release, to be above that mean IL-2Ralpha inhibition level, then you can expect a much greater survival than what they allready demonstrated, which was already great.
If this is true ( I am speculating what they have done with the release specification)..... this is absolutley MASSIVE. We are talking a further 50% mortality reduction in 180 day mortality, ontop of the allready great results. That would give you a 180 day treatment graph that looks like this
..... please, please, please be true !
BAAAANNNGGGG
Out of the ball park, game over !
This is not financial advice, and I am speculating that the change to the release criterea, is going to match Dr Kurtzburg's findings that linked the potency assay with survival. Source below
https://tandem.confex.com/tandem/2023/meetingapp.cgi/Paper/22428 Stratifying patients in MSB-GVHD001 (n=54) by treatment with Rem-L product lots with in vitro activity of mean % IL-2Rα inhibition > median or ≤ median showed a positive association between % IL-2Rα inhibition and D180 survival (85% vs. 54%, p=0.01). This was preceded by a greater duration of the D28 OR among responders who received product with higher %IL-2Rα inhibition. The relationship between greater survival and mean % IL-2Rα inhibition > median vs ≤ median was most evident in patients with the most severe form of the disease and at highest risk for death: Minnesota high risk (D180 OS 89% vs 50%, p=0.01), MAP >0.29 (D180 OS 100% vs. 17%, p=0.003) or Grade D disease (D180 OS 91% vs. 50%, p=0.03).
new data showing that the validated potency assay has low variability and can adequately
demonstrate manufacturing consistency and reproducibility, and • establishment of a new specification for release of commercial product based on extensive clinical data which provides assurance that future batches of remestemcel-L will have attributes supportive of expected survival outcomes.
(20min delay)