Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-328

@JB1975 On the fifteenth of December 2021 you stated you thought it should be possible for MSB to produce assays that would work.

Your words below.......

In principle I reckon it should be possible to produce assays for MSB cells that would work on similar principles to those proposed in the CYP patent or patent application I'm reading - ( ie you establish a test comparator set as a benchmarking tool and get agreement from the regulator that a sample from any given batch compares favourably quantitatively with that established comparator set that it is deemed to be ok) even though the cells are not pluripotent in MSB's case they are draw from a pool of healthy young donors presumably and are, in that sense, all genetically and epigenetically probably mesenchymal lineage cells with the markers that you'd expect of such healthy cells and without the markers you might screen for of unhealthy or undesired cells.

I'd be interested in the specifics of MSB's proposed assays if they are in the public domain.



The information you seek is currently with the FDA, the answer will be publicly available before August 3 2023.

Is there something else you would like to talk about- 15 months is a long time to raise the same question?