I like the quote “We do not want the perfect to be the enemy of the good,” said Wallach.
Which potentially is the FDA obstacle for MSB. The treatment in the article didn’t show significance but MSB did for aGVHD, add to that the extensive safety profile for MSB and 9-1 vote, but still FDA seeking more. As I understand FDA has effectively put MSB on hold for conducting the adult study for aGVHD, but has anyone been able to clarify if FDA are still happy for patients to have free access under EAP or the like?
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