Replies to post #40031 on Bioelectronics Corp (BIEL)

[Dubb10]

As another sidenote: Was everyone aware that Biel was (illegally) selling their devices w/o a prescription and proper labeling in the US before the FDA issued a warning letter on 1/31/12? Sales spiked after the Dr. Oz showed aired. Did everyone already know that NSE letters were sent prior to the FDA warning? Was I the only one who didn't know? Or were we led to believe that the FDA is still evaluating the applications?

An NSE decision shuts off the review clock,marks the end of FDA review, and is considered a final action.
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089738.pdf

Biel (and Andy) may have put all shareholders as well as consumers at risk with these actions, whether you side with the FDA or Andy. IMO, Biel was aware of the law, but tried to find a back-channel to sell their products OTC in the US. Lucky for all of us, they got a warning.

If Andy told investors about this stuff prior to the letter, then I will have to admit I missed it. Otherwise (like I said), desperation but also red flags.

The Office of Compliance, in the Center for Devices and Radiological Health (CDRH), reviewed your firm’s websites at www.actipatchstore.com, www.allaystore.com, www.actipatch.ca, and www.bielcorp.com. Under section 201(h) of the Act, 21 U.S.C. § 321(h), the products noted above, which are sold on these sites, are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.

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.”

Furthermore, the ActiPatch and Allay devices are misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1), in that the labeling for these devices fails to bear adequate directions for use for the purpose for which they are intended. Your cleared ActiBand device, K022404, is a prescription device, as described in 21 CFR 801.109. As a prescription device, the ActiBand “is to be sold only to or on the prescription or other order of such practitioner for use in the course of his professional practice.” 21 CFR 801.109(a)(2). In addition, as a prescription device, the label of the ActiBand must bear the statement: "Caution: Federal law restricts this device to sale by or on the order of a ____" – the blank to be filled with the word "physician," "dentist," "veterinarian," or with the descriptive designation of any other practitioner licensed by the law of the state in which he practices to use or order the use of the device. 21 CFR 801.109(b)(1). The ActiPatch and Allay devices, were they cleared, would likewise be required to be sold as prescription devices with required cautionary statements. However, these products are being sold on your firm’s websites, www.actipatchstore.com and www.allaystore.com, without requiring a prescription or other order of a practitioner. CDRH was able to order the ActiPatch BACK PAIN THERAPY device from www.actipatchstore.com and the Allay device from www.allaystore.com, without your firm requiring a prescription or other order from a licensed practitioner. Moreover, the labels of these devices fail to bear the above-quoted cautionary statement.

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

[Dubb10]

I'd also like some examples of publicly-traded OTC companies that initiated a multi-billion share buyback after FDA clearance/approval and subsequent licensing agreement for my own future reference.

[ghost42]

Tell me, why is openly questioning about speculation of M&A's off limits esp when we've seen Groundhog's Day documented in the links I've provided? If you follow the discussions in the links I have provided, the talk is eerily familiar over the past 5 years now. I do have experience with OTC and FDA-based stocks and know that some CEO's don't always tell the full story of what is happening, and investors sympathize with them - whether they're wrong or right. Too many CEOs (not all) are just trying to win the argument with angry shareholders. That is why I take precaution (and advise others to do so too). The red flags are raised especially when I hear the same conversation come up over and over again with a particular CEO and company, all while shareholders are left dangling. I've criticized Andy on some topics, but I've also give him the benefit of the doubt b/c I think he's a bit desperate at this point and trying to do what he can.

I repeatedly see that the default argument on many of these types of boards is usually, the FDA is in the pocket of Big Pharma when the process doesn't go as quickly as many hope. I also see the scam arguments. Between the "pumpers" and "bashers" on a messageboard, (the saying is) the real truth is somewhere in the middle. Mostly the FDA is a hard working organization, trying very hard to see if a product or drug is safe and shows efficacy. But there has been a long time prejudice in that system for this type of therapy, mainly streaming from one doctor in the past that had enough influence to guide the FDA's thinking. So, there was is still is, albeit lessening every year, a bias. Certain pharma's are really good about playing up lingering doubts.

If general questioning and discussion about everything relating to this stock can only be dependent upon experience, how can any (past/present/future) investors on this board without Electronics knowledge (there are a few with knowledge) freely talk about anything concerning this topic and hence criticize the FDA? Especially about:
-how electronic tech should be approved by the FDA without knowledge of how that stuff works plus general AC/DC hazards, As a person with electronics knowledge, you know just as I know that general AC/DC hazards are well known by the FDA experts.

-how the specific testing works for the devices manufactured,This will be determined by the new guidelines, plus they will find out if additional clinical studies will have to be done

-the manufacturing standards as stated by various agencies/organizations, As far as I know all bench testing was completed, the manufacturing facilities at one time had ISO certification, etc. This does not mean that the FDA could not put additional manufacturing requirements or additional certifications on this. As, electronics guys we know that this is just minor. I have taken one apart and looked inside, have you. I promise that with your knowledge it should not take but a minute to realize this is not new technology inside this device.

-what specific questions the FDA has about the safety/efficacy data or clinical testing in general, Some of this was in the last report out from the FDA, but this is the big question.

-the basic issues raised by various government organizations/agencies (not just the FDA) that revolve around the human tissue's absorption of electromagnetic energy without sufficiently researching the documents of the concerns raised The research around "questions' are down to just a few items, hence the FDA has finally agreed to rethink the classification. They would not have made this move if major concerns about the technology remained. This does not mean that they will automatically get approval or the guidelines will be changed, but I am willing to bet the odds are much better. The science around human tissue assorption of PEMF is well known and FDA approved, including a BIEL device, the question is at the power and frequency of the BIEL device promotes the same effect. Again this overall science is not new to PEMF, what is new was the miniaturizing of the device.

To play devil's advocate a bit: some on this board have said ActiPatch/Allay are perfectly safe from the reviews of customers and themselves. What about those with critical medical devices such as a pacemaker where ElectroMagnetic Interference can be a serious hazard? Other devices that can respond to RF or magnetics is always a concern, but the FDA has many approved devices out there, so the question comes on these type of devices is can box warnings sufficiently expected to be a good enough safety warning. Afterall the magnetic portion of this device is mainly inside the area of the loop. The bigger danger is the RF in my mind and looking at the frequency and the pacemaker already built in filters, my personal opinion is that box warnings will suffice because the chance of this device causing pacemaker disruption is minimal but not zero due the possibilities of defects in either the BIEL device or the pacemaker.

The answer should be: there should be no limitations in civil, respectful discussion. That is where messageboards can be beneficial, b/c there are experts in varying fields with varying experience. At the end of the day, we can agree or we can agree to disagree.

Even with my 18 years of experience of AC & DC Electronics in the classroom and out in the field, this particular subject has taught me some extra things over the years about Electromagnetism. I agree that we learn every day, but so does the people at the FDA.

Here's a secret for all investors who think otherwise: experts don't know everything. I personally know an expert in the field of medicine (PhD from an accredited university in public health and holds a management position with a medically-related global trust), and she will readily admit she doesn't know everything with her years of clinical studies in medicine. They have to be re-educated at times b/c technology and conventional thinking in some areas is always changing. In many instances, they have to learn about other fields of study. They have to be persuaded that conventional thought may have to be altered, but the onus of proof should rely on those making the argument. Otherwise, the FDA is spending countless man-hours trying to figure more things out. As I've tried to show in my previous posts, (IMO) Biel was making things more difficult, and the FDA still didn't agree after all was said and done.

The bottom line is that this technology is not new, the size of the device is. How PEMF works is not new, but the Hz of this device is, the question is not will the FDA approve PEMF devices, they have many out there already approved. To me the question is not how safe but rather can box warnings suffice instead of doctors prescriptions, to me the real question is do they believe the efficacy. I think this movement is the first crack in the FDA armor. The only question now that the crack is there is: has BIEL done enough to penetrate the rest of the way. I like the rest of you are awaiting the first pare' of this new round. Please pardon any spelling/ grammer mistakes as I wrote this on the fly.