In hindsight, the nature of the questions posed at the ODAC by the FDA strongly suggested their decision on approval was already made up.
Unfortunately for the FDA, the ODAC vote didn't go the way they'd expected.
I don't subscribe to the theory that the FDA is/was in any way corrupt, more likely it was staffed by overly conservative people who are possibly against "stem cells" generally.
The FDA was always going to set the bar high for a totally new class of treatment. Mesoblast has made it tougher still by repeatedly missing primary endpoints.
While the setbacks have become all too common with Mesoblast, I still have confidence they will get something over the line. Eventually.
MSB Trading 2021 - paradigm shift, page-731
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