From SI (my bolding)
" We remain steadfast in making remestemcel-L available to both children and adults suffering from this devastating disease, and have received substantial clarity in how to bring this much-needed product to these patients”.
So there was ambiguity before the CRL on how to approach approval? - there's the bit that sticks in my craw - surely the FDA has been consistently clear in it's requirement for another trial and its been MSB that's been trying to convince them that RWD is enough to augment the previous trial data
From SI (my bolding)" We remain steadfast in making...
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