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Sunday, May 06, 2018 11:21:46 AM
Can anyone name one positive thing that has been accomplished during the regulatory process with FDA in the intervening time period between September 2009, when the BIEL shares were trading at 12.9 cents, and today?
Sad part is over 140 Million chronic and acute pain sufferers in the U.S. would have had the option, every day for 9 long years, to buy ActiPatch OTC, thereby having a now-proven - and FDA endorsed - and FDA OTC cleared option for drug-side-effect free efficacious and safe as compared to being limited to harmful drug pain medications.
There has not been one change to ActiPatch, not one, that would not have occurred had FDA general clearance been issued 9 years ago and that's sad for all pain sufferers, including tens of millions of women who could have been using Allay for , hmmmm, 108 months . . . for dysmenorrhea, severe menstrual cramping and pain. And arthritis, and migraines, and C-Sections, and pre and post-op, and, and, and. Sad . . . how a better quality of life opportunity for so many millions of Americans has been held up.
The rarely surfacing revengeful part of me hopes that those responsible will feel some form of guilt deep in their conscience, although they will never admit it.. . . . . Never seen a politician or regulator yet who says, "we blew it", instead of "they blew it". FDA was hugely responsible when it declared it didn't have the scientific expertise in-house to assess ActiPatch, promised to hire such talent and did! FDA and BIEL have invested millions in the ActiPatch clearance but overall, on the ActiPatch general clearance, "We all blew it!" . . . . because I've been using it for 10 years, whenever I've needed to along with many thousands of others . . . . imminent
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