I'm wating to see what happens when the FDA sdets a "date certain" for the meeting to discuss the 514 submission. I'm also trying to figure out if progress has or has not been made with respect to the 514 stability data to date.
That will be of major importance for investors that hold long. A HUGE unknown is how much, if anything, they have done on 514. Will it come out in the FDA meeting that additional trials are needed? New formulations? Or are we just being extra careful and making sure we punch the holes in the reports in the right spots? From the time of the meeting we are looking at 1 quarter to 5 years before the NDA is submitted. (Ya, I had a lot more faith last week...)
This question, or rather the answer to that question, could go a long way in explaining recent actions. Who knows. I still agree that BMC is an intelligent man - I would want a LOT more transparency before I take another position here though.