My bad. I had habusa on ignore but for some reason thought he was rehabiltiated.

The point is still that MNKD really feels they had a clear agreement with the FDA on the in vitro testing for the Gen2 inhaler, as you say Matt confirmed. As I understand it in vitro testing is allowed for substantially similar devices, so that is really the crux. I can't see how anyone could die or even be seriously injured with this therapy, even Exubera didn't run into that kind of problem. Maybe they could swallow the inhaler and choke? I think the issue really is that the FDA has screwed up so many times recently (including allowing an unproven substantially similar metal on metal Depuy hip replacement which was a disaster for example) that risk aversion is the driving concern. No one is going to be able to say someone died because they didn't approve a device.

I noticed that the Type 2 study has 328 patients in 2 arms. The Type 1 study has 3 arms and 471 patients, so actually just about 800 patients. And on the clinicaltrial.gov site the the Type 1 trial was not updated and still says completion by July 2012. On the other hand the site also says both studies are still recruiting which is probably the case.

I would just like to hear this week that any milestone was met.