Saturday, August 20, 2016 11:02:17 PM
FDA CLEARANCE IS NOT JUST POSSIBLE, BUT ASSURED SOON. . . since they were told by the FDA they were on a path they could/would clear following the FDA acceptance of the 510(k) pathway to clearance. So we are all waiting on something that is almost here. They will celebrate, and I repeat CELEBRATE the 510(K)OTC Clearance which has NOT been denied, in fact BIEL's legal counsel advised it has been accepted as the path to Clearance. Pay attention to clearance developments in the next short while. They are also waiting for the University of Oxford back pain trial, repeat trial, not a study, as suggested. The FDA was very clear they have accepted the BIEL trials and studies AND most recently the UK Registry data on back pain as the third component qualifying as the new FDA RWD - Real World Data. Many readers here are convinced that something phenomenal is about to break open based on the truth and recent developments all a result of FDA leadership in the OTC pain space currently.
BIEL is not on the FDA's radar at this current time, the FDA radar is off because FA and BIEL are working closely, hand-in-hand to provide Americans with a drug-free, side-effect free alternative to getting high, stoned, dumbed down and harmed by Big Pharma and the abuse and over-prescribing of Rx and abuse of OTC drugs.
What will everyone do when they see BIEL shares in their portfolio after clearance? Simple, celebrate as the share price doubles over and over and over. . . . .
Hundreds of millions of shares trading daily while many try to get in on the next disruptive technology to break in America to help the >140Million of our citizens suffering from chronic and acute pain and the devastation of harmful analgesics every day.
Keep in mind BIEL has run twice before on FDA speculation - those days are gone, this is the real deal as the OTC play of a lifetime after FDA has invested many, many, millions and thousands of man-hours in bring this breakthrough into our country. Safe, efficacious, affordable, drug-free, side-effect free pain management OTC? Sound too good to be true? You judge who is telling the truth, who is making more sense. The truth is usually much more simple because it is logical, so do the DD, find what information leaves you saying to yourself, "this makes sense. . . . and ride the pending double tsunami. . . . soon
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