Excellent to read your PDMI post. I'm holding and adding at these levels.
I just want to add that while FDA device approvals don't require the same expense and data collection that drug approvals do, the 3 month approval time for devices is only a guideline. The actual time varies and can take over a year.
That said, the % of device applications that are eventually approved is staggering, so while approval times are longer in 2009, the approval we're waiting for will certainly occur IMO.