Bioelectronics Corp (BIEL)

[Simpsonly]

Hey diarch:
A number of possibilities. . .

The FDA now understands the complete safety and efficacy of PEMF/SWT and is revising the Proposed Rule significantly to illustrate this. It's possible they could rate ActiPatch as dangerous as chewing gum, but the device would be difficult to swallow, so that rules out choking on it. Makes sense there should be cautions re use with a pacemaker on board, but folks with pacemakers are educated to be careful, or infants, okay, but otherwise, no one has illustrated any risks.;

Caution in preparing Special Controls and label requirements for manufacturers;

FDA workload and order of handling, which was referred to in one e-mail; and

The significant amount of work involved in 'getting it right', through the entire re-classification process, to the issuance of a Final Rule in the Federal Register. Many of the brightest minds in America are at the FDA, but the process in very involved and it must be right.
Hope this helps