After thinking little longer I remember why they rejected with hiv , because Ibalizumab had it by then for resistant patients and they said we will have over 200k patients in combo so this is not for ODD.
With GvHD FDA told them to do animal study , they did with 32 mice , because results were 100% , it was hard to believe so they repeated few times and FDA gave them ODD, so with TNBC they should receive .
Good , all this is helpful with fast approval ..