Ann: FDA Accepts Mesoblast's BLA Resubmission for Remestemcel-L, page-241

@JB1975

Thank you for your choice of colouring, which you specially added for me. It is greatly appreciated. So, this announcement in March 2024, which must have been cleared with the FDA and the Board of Mesoblast, explicitly states that the FDAinformed the Company that existing data from GVHD001 appears to be sufficient to support submission..by implication .. without a further trial , for those “amplifying idiot” shorters who cannot come to terms with the facts. I am sure you’re going to like the new proprietary potency assay by the way. I am sure Mesoblast would have spent a great deal of time validating it and backtesting it, so that it can be used to identify any individual lots which do not reach the required potency level. The FDA must think it fit for purpose or they would not have told them to refile I accept that Mesoblast still represents a binary risk , but at this late stage, with so many boxes ticked, I think the market is in denial about the very high probability of a successful resubmission , for a first in class therapy, for a whole host of inflammatory diseases. The FDA would be pretty stupid to inform them to refile and then reject the new potency assay they have just opined on ….Looking forward to the update at the end of the month. OP



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