Bioelectronics Corp (BIEL)

[Simpsonly]

Hello shado - I submit FDA had the necessary juice to create the new category for Class II and re-name it SWT - the Final Order.

I'm not really interested whether physicians could then Rx an ActPatch (not a Recovery RX, but an ActiPatch) device under the new Class II for a patient suffering from pain, thus making it a legal RX on-label fill, perhaps covered by insurance, as opposed to an off-label RX fill, which, of course, would not be. I'm only interested in OTC.

The 510(k) application for OTC Clearance - going the extra mile, as it were, is another issue. I also submit there is always much more work to be done than bashers and readers ever understand - Special Controls, label issues, a thousand things to be considered.

Until one has been through the process on an intimate and detailed basis, and paid for it, as I certainly have as a corporate director, one cannot fully appreciate the complexities involved, or the care taken by FDA. The mantras, 'patience' and 'soon' I have tried to espouse truly are most appropriate, though the tick tock can be frustrating - they will get it right and thank God the FDA is there - charlatans would inundate our markets with untested drugs and do much more damage than big pharma currently does with cleared drugs. . . . . . . just for the $$$$$ - melamine in baby formula???