"The 12-wk PK/PD analysis will assess dose dependency"
Oh really? And what different doses will be compared? There are only 2 different arms for Ph 2, 30mg and 50mg. Do you know something I do not know? The title of the poster refers to the Ph 2a trial. It is merely a placeholder.
You'll have to explain how Part B will produce dose dependency data without dose variation since you can't establish correlation without an independent variable. We don't know the AICC's definition of "substantially new", but it is hard to square with dose dependency data that was released 6 months ago.