good post, and that makes sense - frankly, that anything takes a long time with the FDA - including lifting a hold.

my broken record message is that if we can name a CEO (soon) with some experience and relationships with our regulators and BP, etc. - and with a business focus here (maximizing shareholder value), it would re-energize things with the company. I've mentioned before - but i've been watching another company in the biotech space - they have had some success with the FDA - but it seems to be because they have a solid relationship with the reviewer. The reviewer has seen the way they handle things, do what they say they're going to do, etc. - and he seems inclined to work with them and to (somewhat) expedite the process. In other words, the FDA is just a group of individuals - and if you don't have a relationship with someone who has a vested interest and can shepherd you a bit, you're just a name & number - and will likely fall to the bottom of the pile along with the thousands of other applicants.

I am really hoping that this week or next we get a PR about a new CEO - and it's someone who is connected, business minded (maximize value for shareholders), and a great communicator. i know that's a lot - but a guy can wish....