"For mine the FDA don't want to approve cells therapy as there are to many variables in consistency , efficacy, and batch to batch control for them to tick something off"
Has always been the elephant in the room for GEN 1 harvesting and manufacturing companies like Mesoblast.
Osiris tech is over 20 years old.....
Mesoblasts "improvements" have been tiny.
The big promised improvements have been "finalizing" for 8 years
Then Novartis was going to solve it all with another US$50m...
Time is their only advantage, and that is eroding away yearly....as MSB and Board tried to short cut approval with less than robust data and controls.
2022 ... Get your popcorn out!, page-502
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