| I seem to recall either nJoy or SE stating in reference to their suit with the FDA that approval as a drug delivery device would take 8 years and cost over a billion dollars.
I've been reading the daily docket update over at ECF, and I think that's where I read it. I can't find it again, as the thread is over 60 pages long.
From what I've read, it doesn't look good for us... |