Bioelectronics Corp (BIEL)

[GetSeriousOK]

The Oxford study is good for BIEL because:

After the FDA rejects the latest 510(k) they will probably come to the realization that they need to do a PMA, not a 510(k), because there are no predicate devices cleared for OTC pain.

For a PMA, more clinical data will be necessary because most of BIEL's current "clinical data" consists of surveys and testimonials which do NOT impress the FDA. A placebo-controlled double-blind clinical study would do a LOT towards getting this gizmo cleared by the FDA.

The CEO promised the FDA decision by 12/31/2015. I laughed at that "guidance" then and I'm laughing now. This CEO is pretty funny, really.

Regarding the R/S we all know is coming eventually: When a legitimate company does a R/S they also reduce the A/S. When a pinkie scam does a R/S they don't reduce the A/S. Guess which one describes BIEL.