Good question dolby and, naturally, the answers are all speculative, but it's interesting to assess the possibilities. Some thoughts.
- Shares in 09 were something like 1.2 or 1.3Billion, now north of 5.5Billion, but big deal, look at the market cap, it's peanuts.
- Who's to say that 12 cents was the appropriate high for the 09 run, that was more based on short-term hype by a promoter than the current solid reality of the FDA authoring and leading the new Class II initiative? Would BIEL have run to 25 cents, 50 cents, much higher?
- It is evident BIEL was ill-prepared, even stumbling, to enter the regulatory process in 09 and the FDA declared itself seriously lacking in knowledge and horsepower to regulate in the PEMF/SWT space. It seems both parties have resolved those issues, the FDA with total transparency as to it's previous inadequacies, and the doors are being thrown wide open.
- The scourge on American society of Rx and OTC legal drug abuse was not as pervasive and had not been exposed much in comparison to now in 09, it's now a top priority for media, government, the AMA and our citizens.
- 5 years later, the muti-billion $ pain management market awaits a substantial socio-economic, public solution.
- timing is becoming interesting at the FDA. We're just past the 180 day term they self-mandated, it's Labor Day weekend, so we have vacations ending, back to school and summer's over in DC, so, it's back to work everywhere with the media hanging on every word and the political optics are huge.
- Whelan pushed too hard when he got an FDA no, ruffled some feathers there, didn't quit, which is to his credit, served his penance, kept the company alive, probably by dilution, strengthened his scientific and management team significantly, we Americans love to and should forgive, and this just might become a great story of the little American company, led by an ex-marine, that could.
I'm interested in your opinion on share price and timing: (a) when the new Class II final Order is published in the Federal Register; (b) based upon what might that actually look like; (c) how will the market behave when BIEL files its 510(k) application seeking approval under whatever the new Class II requirements are, including Special Controls and labeling for small children, pregnancy and implanted electrical devices (pacemakers) and the OTC application component; and, (d) what will the stock run to on potential FDA OTC approval, the current realistic goal, given the satisfactory status of these devices in areas of efficacy, public safety and not one negative side-effect, other than indigestion if you eat an ActPatch.
