Hi greenshoots11, it boils down to the fact that the FDA usually cares little about results from other countries. The data MSB present to the FDA need to meet their (FDA's) criteria. MSB can scream as loud as it wants about results in other countries - it wont make a difference to the FDA unless the data meet their submission criteria. The data out of Japan does not directly answer the questions raised by the FDA regarding MSB's aGVHD product.
The FDA are the gate keepers to the largest market in the pharma world - they can be as stringent or fussy and exclusionary as they want.
Growing doubt on COVID-19 Application, page-3348
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