The way the announcement made no mention of the adult trial makes me think that the company’s sense is that this might become a full approval which is not conditional on the adult trial commencing, even though it will be happening anyway.. (Remember it won’t cost much because of the BNT-CTN involvement but if successful will vastly expand the market.)
Hope this is the first of many goals being kicked.
Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-85
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