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ddls

02/19/15 10:19 AM

#46414 RE: Simpsonly #46413

The BIEL PPS and Volume Indicate PRE-FAILURE!!!

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 The FDA approves many drugs that subsequently have to be withdrawn for safety reasons.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.

seven-up

02/19/15 10:42 AM

#46417 RE: Simpsonly #46413

Hey Simpsonly, I was surprised that the FDA re-open the docket. Must be something coming soon, the MM's are working the same amount of shares roughly 35-50 million passing them around. We are receiving a lot post with the advise to sell, so they can make their click or two.

I am not sure that Andy is diluting shares, I think it is the Market Manipulators doing what they always do on pink sheet companies, that have a potential uptick. Scare people into selling their shares and buying at low prices. My opinion

Great to hear from you and hope all is will.



NoPinkScams

02/19/15 11:09 AM

#46419 RE: Simpsonly #46413

The comments also lead one to the obvious conclusion that such devices warrant immediate OTC designation.



Wow, that's a pretty amazing leap in logic. Regenesis neither mentions, nor requests OTC clearance in their letter. This is a well written response, but I don't think the FDA is going to change their stance on clinical data requirements. The panel was clearly skeptical of the effectiveness of these devices and highly critical of the studies currently available.

JustGarden

02/19/15 11:56 AM

#46426 RE: Simpsonly #46413

Right on, Simpsonly. GO BIEL!!!!