Ann: FDA Advisory Committee Sets Review Date for Remestemcel-L, page-746

Congrats, you worded it perfectly. I am neither scientist, nor have much knowledge in the stem cell manufacturing, so this response goes on a "pub test" basis. I accept that being a brand new - and I think medical science GAME CHANGER - technology and still lots to learn and perfect, to me an extensive trial has shown that even if we cannot fully understand and be able to explain all aspects of this new methodology, at the end of the day it WORKS and SAVE LIFES. Actually in ARDS / COVID-19 / etc. it may even do much more, but it is another issue. It is an emotional argument - relate to it very much - that it saves CHILDRENs lives. So how it exactly work today cannot be explained fully - but very substantially, maybe there are some inconsistencies - for dealing with cells - in manufacturing, the over results that it still WORKS. Of course they make the decision, but if I would be in a decision making position, I would approve it on that basis and for further assurance and better understanding an extension of the label and a the trial to adults - guess MSB will be doing it as it MAKES COMMERCIAL and SCIENTIFIC SENSE - will be required. Having an already approved product for adults and comparison of the results could provide further assurance. IMHO, MSB will come out of this with flying colours.