Hello investors , I have been now looking very closely at BIEL. The last time it was supposed to get FDA approval was in 2008-2009 time frame but was under wrong classification. In Feb 2014 it was reclassified and usually 18 months to 2 years later a decision comes. It has a huge potential because any device that goes for FDA approval has 50/50 percent chance better than lotto that has 0 percent chance. Few devices /kits in past that standout are INOL for plavix blood levels that was sub penny on FDA approval went several thousand percent up. VRML ovarian cancer detection kit went from 1 cent and chapter 11 to 32 dollars on FDA approval, NEPH renal catheter company went also from few cents to 2.50 dollars on FDA positive decision. BIEL already in past has FDA approval after eye surgery to decrease inflammation, but most patients after Blepharoplasty get significant decrease in eye swelling without specific treatment so was not a big FDA win. A lot of plastic surgeons have endorsed BIEL, the popular TV DOCTORS show endorsed Allay Patch for cramps during periods. The most important breakthrough was when tylenol 500 got FDA warning and so Vicodin which had 500 tylenol is now nearly completely replaced by NORCO that has 325 mg tylenol. BIEL management is basically trying to project that it is better to use ACTI Patch then take OTC meds. The Elite Northwestern Hospital Surgery professor are also now in the board advisor. In Planter fasciitis BIEL products have shown great efficacy.
Initially in 2008 BIEL had 120 million shares which has progressed to over 4 billion shares. This all has some shady aspect but I think BIEL management are confident they will get the approval, although CEO in August stated that FDA approval is great but not a must ( that is not true in my opinion). I know patient used ACTI patch with knee pain resolution.
Overall no matter what happens YES or NO by FDA it is in the Docket / pending decisions
Only time will tell. Thanks