Hey @Phaedrus,
Though by the sounds of how supportive the FDA are seeming to be now of MSB and the data, the FDA may just allow the label extension from the Adult EAP data, and it will be growing by the day under EAP use.
May well be getting up to 200 Adults treated under EAP by the time MSB get to Ryoncil labelling.
That’s some solid Adult data and FDA being all about accelerating Cell therapy that could easily be an option? Thoughts?
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