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2Relax

07/21/16 11:24 AM

#80334 RE: Daytime_Lantern #80331

Big Pharma interference? With the opiod epidemic just now being dealt with, I think big pharma already sees its days numbered.

PATIENCE ...

Great things like what's about to unfold take time to strategically roll out, to maximize the potent end result. NO MORE PILLS needed to deal with pain/healing, just a loop!

With no side effects, when switching from pain pills to the loop, this will not take long before this loop goes viral - - - >

Just my 2 cents!

Long and Strong - Go Biel
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GetSeriousOK

07/21/16 3:24 PM

#80364 RE: Daytime_Lantern #80331

the FDA will give them OTC clearance someday. But they have to follow their rules. The ActiPatch doesn't have a predicate device that's cleared for OTC pain so the FDA can't clear the 510(k).

The FDA will probably clear a de novo but that's a year down the road.