Bioelectronics Corp (BIEL)

[Daytime_Lantern]

Well, BIEL still may have a consolation opportunity, after that monumental failure at the hands of the FDA. The opportunity of which I'm referring is the resubmission of a 510(k), with a women's bias. Apparently, the clinical trial metrics were gender bifurcated, which gave the FDA the opening to deny in the first place. So, why can't BIEL use the women's prong of that clinical trial data for an expedient 510(k) resubmission? Thus, such an exercise shouldn't take an exorbitant amount of time. They should be able to do that within a few months, are so. Also, what about the Allay product, the trials for it is complete, correct? So, what if BIEL submitted a 510(k) for it early next year? Thus, the results of that submission should be available before the summer of next year. Now, I'm not saying put all your Actipatch eggs in that "All Important" FDA clearance basket, BIEL. You should be able to chew gum, and skip at the same time. Yes, work on your sales and branding responsibilities, as a primary focus. But also dedicate a cadre of BIEL technical folks to concentrate on securing FDA clearances, as a plenum group, if you will. I can imagine this happening all within one calendar year, why not? Hey! Maybe I'm missing something, and maybe I'm all wet on this, but it's a plan, right? All as MHO, of course!!

GLTA!!!