Closet, If I remember correctly and at the end of the fda's analysis, they definitely asked for the data for the Mono-therapy trial as well and at that time, they already had all the data from the Combo, no? I agree that it's illogical to ask for that at that period of time when we were waiting for the decision. Then the RO BS entered the picture as another delay tactic. From what I've gleaned from all the PR's etc. etc., RO information may not even be needed, therefore, yet another fda delay on HIC - GLTU