Biodel is using approved GRAS components, a cocktail that changed the pk. So nothing unapproved within the formulation. Its moot on Biodel, its unlikely to be approved without a new trial and there were injection site reactions that make it unattractive commercially.
halo management has done a terrific job. Number one though is picking good programs to work on. I'm just more sanguine on the insulin program, I'd call it a potential single or double, not a homerun.