@Cauggie,
Thanks mate, I am seeing most of the information I have been working off has been company or 3rd party supplied.
For anyone else, check out http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/anestheticandanalgesicdrugproductsadvisorycommittee/ucm393782.pdf pages 4 through to 8 will provide you with FDA summary of events leading to AdCom..