Bioelectronics Corp (BIEL)

[DewmBoom]

The FDA never intended to clear Actipatch but as a prescription. Don't forget that part. There is nothing mentioned in the SWT federal register about OTC other than a vague line, based on a response to a comment. The entire new ruling was intended for Prescription Only.

For Biel to make a case for OTC and entice the FDA to create a new pathway for its clearance is historical and never been done before for a company. That is not only an A+ but also an outstanding achievement, with a historical legacy.