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clock Created with Sketch. 03/03/24
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Originally posted by Showtime
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Re this Oz Federal Court Class Action issue against MSB : Horsky & Anor v Mesoblast Limited (VID268/2022) – Claims of misrepresentation & not disclosing material to investors etc – Period : Feb 2018 to Dec 2020We have been absolutely transparent the whole time so one would have to make their own assessment” "The FDA is a bureaucracy, but with very pragmatic new leadership , and one has to be persistent and provide them with what they ask for". after that 9:1 ODAC voting fiasco a few years back that decimated the share price, it appears the FDA are solving problems in a sensible way now that suits the conditions that really exist - MSB in my view offer alternative options to meet “unmet needs.”Why I invested in this Company Remestemcel-L is being developed for inflammatory diseases in children and adults including steroid refractory acute graft versus host disease, biologic-resistant inflammatory bowel disease, and acute respiratory distress syndrome.Rexlemestrocel-L is in development for advanced chronic heart failure and chronic low back pain. Two products have been commercialized in Japan and Europe by Mesoblast’s licensees, and the Company has established commercial partnerships in Europe and China for certain Phase 3 assets.
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Nope, you look at the subtle language changes from the "prespecified controls" of the aGVHD 001 to "hypothetical controls" after the FDA picked them up. Then the potency assay changed from "validated" to "improved". These are critical points, not just small exaggerations. Not to mention all the dramatic language around mortality rates "as high as 90%" that is seemlessly derived from cherry picked ranges of "60-85%...
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