Could it also be we put a hold on production with

Could it also be we put a hold on production with Samsung and therefore the manufacturing part of the bla is not active? We already submitted the non clinical which I believe is the safety data so there should not be problems there. I would guess any data discrepancy would have appeared then. Could it be a extension patient past away and the fda wants to know if it was related to leronlimab and until they do the temporary hold is in place?