they will want the FDA's blessing at this Type A meeting before they lodge anything. Who knows they might get a straight AA out of the Type A meeting.
what's for sure is that they now know they need this adult trial, so that design is being worked on and they will be seeking the FDA's tick for that trial at this type A meeting and should get that up and running by years end.
manufacturing and potency assays issues appear to be addressed.. as well as safety. this is the last hurdle and if they are targeting the sickest of the sick (grade C/D SR-aGVHD).. they might not have many 'controls' alive after 60 days of enrolement.. which is cruel, but that is what the FDA need to see.
they will want the FDA's blessing at this Type A meeting before...
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