CBB, The FDA is focused on paperwork and politics. In 2012 FDA followed their most recent non binding guidelines and gave us a crl for the anchor indication. Now it looks like the current line of thought from this bunch might help us. After the adcom, 10 years ago, I researched the science. I came to the conclusion that people from Japan are in fact people. I assumed that R-IT should have results not dissimilar from JELLIS. Science has a predictable nature. People do not. The past studies tell us BRAVE should be successful. Current FDA policies and actions suggest that if successful it should be enough for approval.
We will see.
Sleven,