Sunday, January 15, 2017 8:21:09 AM
A few thousand feedback responses in the back portion of the UK register, they were culled out for the FDA from the others. . . .
Say 5,000 back responses in all . . .
10 people who can read . . .
All looking for the slightest hint of anything negative . . .
50 per hour each - 500 per hour total - 1 day 5,000 reviewed.
The negatives on this table, the positives on that one, to be ignored forever, . . . . because . . . we are looking for negative data only . . . git 'er done boys.
>140Million Americans in chronic and acute pain deserve a drug-free, side-effect free break ASAP. And, perhaps even more important; all y'all up there in FDA land and DC - explain to your wives, sisters and daughters and lady friends and America why women do not deserve the break of having a non-drug, non side-effect, efficacious solution for severe monthly menstrual pain and cramping much of their adult lives . . . . good luck with that explanation, you guys are playing with serious fire . . . . "uhhhh, well, you see, it works thisaway, I know Allay is drug-free and side-effect free and would make you feel a lot better, but we need more time??" Right, that should make sense! About as much sense as the $20 Trillion buffoonery hole we're all in together . . .
Now, a couple of months to write, circulate and approve the clearance letter and publish the new verbiage making clearance of SWT OTC approved devices OK. Remember, first clearance for OTC, then approval for the devices as submissions are received and assessed . . . . Anyone who doesn't think BIEL is ahead of the game is still hoping to make buggy whips, land line telephones and handheld calculators forever. That's the cool thing about patented, miniaturized, medical devices - they are an emerging phenomenon, and like any disruptive technology, like the car and the light bulb and the computer, take a while to get going . . . FDA OTC Clearance ActiPatch AND Allay USA . . . . you know when
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