well..without knowing what's really going on internally, we simply can't say if it had to be this way or not.
From an investors POV..those of us that actually saw the product (or bought it) should be the most dissapointed with the way things are. I've never minded 'investing' in something that was losing a bit of $ while the company built itself up, as long as everything was out in the open. Plenty of great companies start out with losses.
as much as the lack of FDA approval (for INTENDED USE) is part of the problem here, there ARE plenty of other places where the product is doing well, is approved by regulatory agencies, etc. TO ME, it's very simple..the LACK of regular, quarterly filing and financials and the lack of information is what has driven this stock to these depths.