Spotted this as the first (other) attempt to manage the process which the FDA obviously has poorly done. They somehow must get the discussion back in the private sector while they (FDA) get back into their objective regulatory body mode. Not clear if this will work or not for them b/c they seem to kind of like being the 900lb gorilla.
In the case of (at least AD-CNS diseases) the FDA trials process has badly failed. IMO, they need to re-engineer and reinvent themselves. They seem to get conflicted and get into trouble when judging the results.