Bioelectronics Corp (BIEL)

[kidnova]

The studies BIEL has conducted to date wouldn't cut the mustard in a PMA application. Maybe some of the new studies they've announced:
http://finance.yahoo.com/news/bioelectronics-expands-clinical-research-140000780.html
will be more scientifically rigid, but I haven't heard much on the studies they announced last year either.

They are, of course, hoping that they won't be forced to go the PMA route, but that seems to be the direction the FDA is leaning. There still is the question on whether or not they will be successful in getting it moved into another category altogether, but the FDA doesn't seem to be in a rush to consider that request.