Thanks. Of course, I can't prove anything, and we don't know communications etc., but I find it strange that they let them go through every additional delay possible and always seem to ask for more when submission seems close. Well, now it seems that there isn't anything more on the clinical part they could ask for.

Normally, the pre-BLA meeting(s) are to communicate what FDA wants; if they had said last March that they wanted all data from monotherapy etc. that wouldn't have been a problem...