FDA was asking for 50 patients on 700 mg monothera

FDA was asking for 50 patients on 700 mg monotherapy for combo..and I think 100 patients on 525 mg , . we knew that..

Now they want all records from momotherapy , all 595 patients ,

all on 350 mg
all on 525 mg
and all on 700 mg..

This is difficult to explain only for combo..


IMO only.