Bioelectronics Corp (BIEL)

[Gramps]

I, of course, disagree with that entire statement. The labeling requirements were something that came up from their meetings, after the FDA opened the door to the new possibility of a 510(k) after all. If that is indeed the case, as I believe and you don't, then they would then move and only then--on what was needed for labeling. The FDA wasn't even thinking about clearing the product before and wouldn't spend a minute of time in that phase of the process. Period.