A lot of us holder feel the FDA, unprecedently, going against their own 9 - 1 advisory committee goes against countless other example of where approval had a much lower bar.
The FDA very much is in a constant learning process, constantly releasing opinions and guidance as their divions develop. Considering the FDA are not doing their own stem cell development and manufacturing they would absolutely be learning from those developing it in the field. Pretending they're not is where there would be ignorance and attitude.
Ann: Mesoblast Partners with BMT CTN on Adult SR-aGVHD Trial, page-238
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