Bioelectronics Corp (BIEL)

[challengemyknowledge]

I haven't seen ANY information that would suggest

BIEL will receive ANY OTC approval in the U.S, NONE!!!!!!!

(CORRECTION)

Review the following facts, and maybe I'll hear why by belief is wrong?

Given THE FACT that ALL BIEL "brands" ARE REALLY just ONE/THE SAME product, because THEY ALL contain THE EXACT SAME technology, WHY would there be ANY FDA approval for the company?

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=77155687

"The Company was granted its first approval from the FDA under a 510k in August 2002. Prior to FDA approval and the establishment of its research and development group, PAW, LLC (Andrew Whelan's wife and children) paid and expensed the cost of development". In 2003, BioElectronics redesigned the ActiPatch product to reduce its size and costs to manufacture and developed several new products."

http://bielcorp.com/about.html

(I DIDN'T INCLUDE THAT LINK IN THE PREVIOUS VERSION OF THIS POST. I APOLOGIZE, SINCE I LIKE TO BE THOROUGH WITH THE INFO. I PASS ALONG)

The product that was given FDA approval was their ActiBand device.

http://www.510kdecisions.com/applications/index.cfm/id/K022404/index.cfm

It appears that when they redesigned that product, they must have changed the technology, also. Because "if" Allay Patch had the same tech. as their FDA approved ActiBand has/had, Allay would not have been denied OTC clearance in the U.S. As BIEL CEO confirmed 4 different times in the first link, ALL CURRENT BRANDS ARE REALLY JUST ONE/THE SAME PRODUCT!!!

Dear Mr. Whelan:

The Food and Drug Administration (FDA) has learned that your firm is marketing the ActiPatch, RecoveryRx, and Allay products in the United States (U.S.) without marketing authorization, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).

Your firm currently has an FDA-cleared premarket notification (510(k)) for the ActiBand device, K022404, which was cleared on August 8, 2002. The indication for use (IFU) statement for your ActiBand device is, “for the treatment of edema following Blepharoplasty.”

Your websites and device labeling for the ActiPatch, RecoveryRx, and Allay products include the following claims that FDA considers to be outside of the IFU for your 510(k)-cleared ActiBand device. These claims represent major changes or modifications in the cleared intended use of the ActiBand device, under 21 CFR 807.81(a)(3)(ii).

A review of our records reveals that you have not obtained marketing authorization before you began offering the above-noted devices for sale. You submitted premarket notifications for the Allay device on April 30, 2010, for the ActiPatch device on July 22, 2010, and for the RecoveryRx device on April 6, 2011. CDRH determined that the ActiPatch, (b)(4) are “not substantially equivalent” (NSE) to any legally-marketed devices. In (b)(4) CDRH’s NSE decision letters, CDRH stated that, “Any commercial distribution of this device prior to approval of a PMA, or the effective date of any order by the Food and Drug Administration re-classifying this device into class I or II, would be a violation of the Act.”

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm292029.htm

Hence, given THE FACT that ALL BIEL "brands" ARE REALLY just ONE/THE SAME product, because THEY ALL contain THE EXACT SAME technology, WHY would there be ANY FDA approval for the company?

They can come out with just one product for ANIMALS, that do the work OF ALL BRANDS. But can't do the same for HUMANS?

http://www.marketwire.com/press-release/bioelectronics-introduces-its-new-disposable-device-to-the-us-market-1366532.htm

Just think of how many female HealFast purchasers, could have purchased Acti/Allay Patch/Recovery Rx, also? And it's STILL just over $5 mil. in sales since inception.

Keep BIELeving:)