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08/06/17 9:45 PM

#111818 RE: WHELANer #111817

Have to be brutally honest here stick, I don't know. I thought FDA would have created the synergy inside necessary to fast-track ActiPatch in 2011, 2012 at the very, very latest. Who could ever have predicted the snail's pace of getting the foot and knee cleared last February? Certainly not me, not in a million years.

Was management responsible for a portion of the delay? Yes, through inexperience and monetary struggles, but management was correct; it works and it's totally safe and the FDA has endorsed those two issues and is that not the real issue? A bigger issue, in my mind, is that FDA is to a great degree impervious to hurry-up and sense of urgency. They know and have stated it works and is safe. Sloth is one of the 7 sins! World War II lasted almost 6 years, start to finish. Getting ActiPatch fully cleared should take a week, no more, by comparison, now that the FDA has already endorsed it by RX approval and OTC clearance for 3 indications!

It is solely on the FDA to go the next step to help tens of millions of Americans in pain. Shameful that it was not yesterday! What's to lose? What's the downside? What's the exposure? Sit back quietly, close your eyes, imagine for 5 minutes what the headlines above the fold would scream if FDA were to take the initiative and say to the country that it has taken the biggest single step it could imagine in enabling a single and wonderful solution to a significant portion of the pain drug abuse epidemic . . . . . drug-free, side-effect free pain management in every pharmacy in America OTC. THAT is what BIEL is poised to deliver to the American people . . . . nothing more and nothing less.

How do I know? I've used ActiPatch a number of times, over the past 9 years! Specifically when? General clearance and a deal? Don't know stick, but it would sure help millions in in acute and chronic pain sooner,if it happens now. Further delay is a form of institutional cruelty and there is just no excuse for it! And don't forget about the money! Never forget about the money . . . .less Doctor appointments, less travel, less time, less prescriptions, less expensive drugs, less addiction, less, less, less . . . .and pain better managed. Follow the money and follow the sloth stick. Hope this helps . . . .