Bioelectronics Corp (BIEL)

[NoPinkScams]

What a ridiculous filing. There is no point in filing this prior to the reclassification because the FDA isn't even going to bother looking at it until that process is complete. The FDA made it very clear in their panel discussion and the proposed rule that only scientifically sound clinical trial data would be considered and only for specific indications so the recently published survey results won't even be a consideration.

The proper course of action would be to wait until the final order is published and then apply for class II approval for Osteoarthritis treatment based on the results of that study. The rest of their studies have already been reviewed and dismissed by the FDA as flawed. During the meantime they could continue their European and Canadian marketing push.

This stinks of a PR stunt and brings back unwelcome memories of the Joe Noel days.