While hunting around to locate the Bioshares article, I came across this interview with Bryan Dulhunty by Wholesale Investor
25 Feb 2011
http://insider.thomsonreuters.com/link.html?cn=share&ctype=group_channel&chid=789373&cid=194844&shareToken=Nzg5MzczOjNmZWE2ODkwLWI3M2EtNDY3MS1hZTI4LTE1ZTlhMzZiZTBkZQ%3D%3D&start=0&end=502
Pretty interesting stuff. Talks about the science prior ~6 minutes, and FDA, future post 6 mins