Replies to post #135041 on Bioelectronics Corp (BIEL)

[Simpsonly]

Here's a question for you Investor100, and everyone else on this board, at least those who also exude common sense, as you do . . . .

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

[Investor100]

Looking forward to more news @ BIEL

Been around this company since 2009 and without a doubt I have seen lots of changes with the management team and its products. The products work for me ( lower back and shoulder) thus I continue to own and add shares when possible ( 12M ). As we know Rome was not built over-night and BIEL is just getting started to a much bigger and brighter future.


https://www.marketwatch.com/story/bioelectronics-to-meet-with-fda-to-seek-expanded-otc-clearances-2018-05-02

May 9th, 2018.
The first meeting will take place on May 9th, 2018 to seek expanded indications for OTC treatment of all musculoskeletal pain for its ActiPatch(R) medical device. BioElectronics currently has OTC clearances for adjunctive treatment of two types of musculoskeletal pain: 1) Knee osteoarthritis 2) Plantar Fasciitis. Per the FDA's requirement to obtain clearance for all musculoskeletal pain, the company submitted the results of a low back pain clinical study, via a Pre-Submission in April 2018. Full details about the study can be found at the NIH's clinical trials listing page.

May 29th, 208
The second meeting will take place on May 29th, 2018 to seek expanded indications for OTC treatment of pain and edema following surgical procedures for its RecoveryRx(R) medical device. BioElectronics currently has a prescription-only clearance for the treatment of edema following blepharoplasty (eye-lid corrective surgery). The company has submitted clinical evidence to the FDA from a breast augmentation study and C-section study, via a Pre-Submission in April 2018.

https://clinicaltrials.gov/ct2/show/record/NCT03240146?term=actipatch&rank=10

Sree Koneru, Ph.D., VP of Product Development at BioElectronics
expressed confidence in the upcoming meetings and in the strength of the clinical evidence. "The clinical studies that were submitted have been conducted in an independent and rigorous manner, so we are looking forward to working with the FDA and seek their guidance to obtain expanded market clearances in a timely manner," Mr. Whelan said.

No luck needed just some patience!

Investor 100