I admit this is not proof-positive but with a look at the dates and a little calculation...

http://www.miamiproject.miami.edu/page.aspx?pid=979


My thought is that, it says that the IND was submitted on September 21 and the FDA has thirty days to respond: good or bad. And oddly enough if the FDA does not respond, then the trial is allowed to proceed... Well it's been more than 30 days since September 21. So there has to be some news one way or another?