Howdy. New here (and to VNDA). I didn't think Nov. 14 was a hard date (line from PR below), but rather a tentative one. And with the government being shut down, don't you think that is likely to be pushed out? Many thanks and good luck!
The FDA has also tentatively scheduled an advisory committee meeting to discuss the tasimelteon application on November 14, 2013.
Looks like show time. Does anyone know what actually happens at these reviews? Could it actually be accepted/rejected during the meeting, or is it simply discussed?