Bioelectronics Corp (BIEL)

[rodman]

RED CARPET will roll out soon enough. FDA amended their rules for soley reviewing clinical trial data thanks to BIELCORP! This is eluded to in many cases specifically their AGREEMENT to rely on data other than the typical De Novo pathway therefore the rules for ALL electroceuticals (and there are many in line with products in the pipeline) J&J etc.

Striking true statements:
It represents a paradigm shift in pain management behavior.

"we previously put out a brief press release noting that last week’s announcement from the FDA was very good news for BIEL. The U.S. Food and Drug Administration’s final rule 890.5290 on nonthermal pulsed shortwave devices will assist our efforts to win clearance to market over-the-counter in the US as it is already allowed in the majority of countries around the world."

The examiners have also agreed to review our UK Registry back pain data to accommodate our broad relief of musculoskeletal pain indication of use request.

We believe the data will be acceptable in lieu of a controlled clinical trial for back pain to support an over-the-counter musculoskeletal pain indication through the premarket notification process.