BUT - FDA is also a leader in a small group of, collectively, the most intelligent folks on earth. Yes, they are essentially in the scientific/Regulatory community, which does not intrinsically embody wisdom, as a natural by-product, as in commercial enterprises, but they are still very, very bright.
I have long felt and said the FDA is made up of decent, law-abiding people and is not deliberately delaying anything one day longer than necessary. They are certainly not stupid enough to risk any accusations from any quarter of playing favorites or yielding to the persuasions, romancing, wining or dining of pharma lobbyists. I would say that Big Pharma would see every day of delay of the 510(K) Clearance of ActiPatch for OTC sales in the US as a gift of a day of maintaining current market-share and sales of their poisonous drugs or another gift catch-up day while they scurry around seeking wannabe SWT imitation devices.
Nope, FDA is leading the SWT project they designed and they named and the reclassification they implemented which will evolve to the rollout to market of devices for pain management rather than poisonous drugs. I would also assume they fully 'get' the magnitude of the BIEL patented disruptive technology. The need is there what with >140Million Americans suffering from chronic and acute pain every day of their lives and don't think for one second they don't 'get' that too. Why else would they invest thousands of man-hours and tens of millions of dollars? . . . . . Tsunami.
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