Bioelectronics Corp (BIEL)

[GetSeriousOK]

The BIEL company updates from Grace Holdings clearly show that a month after the FDA agreed to "review" the "Real World Data" that BIEL submitted, the FDA asked for a controlled double-blinded clinical trial for back pain.

That tells us what the FDA thinks of that RWD.

Geez, indeed.

Note that the FDA won't tell us anything about a 510(k) that wasn't cleared and they won't tell us anything about active current applications. Also note that BIEL doesn't HAVE to tell us the status of their FDA application.

BIEL chooses to make only Safe Harbor statements like "WE submitted a 510(k)" (which is true) and "we believe the ActiPatch will get OTC clearance" (probably true, who knows if they really believe it). If the application changed to a de novo as I believe, none of their Safe Harbor statements are lies -- notice how carefully they were worded.

They SHOULD tell us but they don't HAVE to.