Scope: List of outstanding issues Action: For adoption
It has been available since publication of the Agenda for this September meeting what would occur. It seems the interpretation of the purpose of pending action upon Anavex was hoped to be otherwise. Sometimes Reality sucks.
The process continues and no matter the outcome one may hope that Anavex is prepared to adequately answer the remaining concerns of CHMP. Speculation as to the actual LoOI is a fools errand.
Thirty days to answer without a request for extension. Lets see how that plays when the next meeting Agenda will be out sooner than that.