I wonder if the CEO will tell investor's of the FDA rejection?
Like the last time BIEL was rejected?
BioElectronics Product Status with the FDA
- Last FDA status update: 5-22-14
The comment period for the FDA proposed rule (Docket No. FDA-2012-N-0378) closed on Wednesday, May 21. BioElectronics Corporation has submitted its official response supporting the reclassification to Class II and additionally presenting arguments for OTC allowance as part of that comment. The FDA will now review the comments. We continue to focus on our efforts on completing our clinical trials and assembling the data we will file as soon as the FDA announces the new rules.
We continue to develop our markets outside the US and educate consumers and the medical community inside the US. As part of our ongoing outreach and education program, an interview with a member of our medical advisory board, Dr. William Van der Reis, is appearing in an upcoming issue of Becker’s Review, a leading orthopedic journal and on last Saturday he was interviewed about how he’s using BioElectronics products on sports injuries in his practice on an ESPN radio show, WeekEnd Warriors, which you can hear here starting at 19:26 into the program. The show is hosted by another orthopedic surgeon, Dr. Robert Klapper, who has invited Dr. van der Reis back to continue the discussion.
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PEMFs and the FDA
PEMF FDA Registration
The FDA registers items, and the FDA approves items. Do not confuse registration with approval. Often, companies tout their system as FDA registered, hoping that the customer will assume that means the same thing as FDA-approved. Truthfully, if a system is FDA registered, that means only that the FDA knows the item is being imported into the US. It is in no way a guarantee of safety. All PEMF devices imported into the United States have to have FDA registration. So, no single device is better than another relative to FDA registration. FDA approval and oversight is not necessarily a guarantee of value or safety, either. The FDA approves many drugs that subsequently have to be withdrawn for safety reasons. That being said, there are some FDA-approved PEMF devices, so we know that the FDA does approve of the use of electromagnetic fields for therapeutic use.
Furthermore, most manufacturers do not want to be FDA approved. You read that correctly; they are not seeking FDA approval. There are many reasons for this, including the high price tag associated with seeking FDA approval. FDA approval also comes with the stipulation that the product be condition-specific. Because PEMF devices treat us at such a basic, cellular level, choosing only one health condition would be a disservice to both the brand and the consumer. Additionally, PEMF systems are, first and foremost, wellness devices. It is not medication – a magnetic field does not change the chemistry of your body. A magnetic field acts on the most basic of biological functions – the cellular level. It’s more physics than medicine.
So, what we have here are people spinning BIEL into something positive and grandiose.
But, the PPS and sales in those 40k countries are weak at best.
Some investor's are a chip (no pun intended) off the old "BIEL Block".
In summery, the FDA is a non event in BIEL'S case.
