In relation to the upcoming approval of Ryoncil.
The way I see it is this.
we have seen a very clear and obvious benefit for the administration of Mesoblast’s mesenchymal stem cells across multiple pro inflammatory and autoimmune conditions by undertaking phase 2 and 3 RCT’s over an extensive period of time. There is a demonstrable variance in outcomes between placebo groups and those receiving stem cells which is highlighted by clinically significant p values and Improvements in patient functionality, ejection fractions, pain values and so on, across essentially all clinical trials that mesoblast has undertaken with no safety concerns (aside from maybe pump thrombosis which had no correlation to the stem cells and is a known issue prior to their trial). I cannot stress enough that It is outstandingly clear that these stem cells have an impact on modulating the inflammatory process, regardless of whether the MOI is known, this will not hinder the approval process. Like I correctly anticipated prior to the ODAC vote, we will be approved, maybe they will want to generate a testing process to ensure consistency of stem cell batches however I am 100% certain that silviu is 10 steps ahead and prepared for such an outcome just like he was prepared to answer any/all difficult questions ODAC had for him. Good luck to all those holding before the 30th, you won’t need it, I look forward to saying I told you so on Thursday
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- Ann: FDA Advisory Committee Sets Review Date for Remestemcel-L
Ann: FDA Advisory Committee Sets Review Date for Remestemcel-L, page-674
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