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That's why it's called an assumption, and an opinion.
Kelly Whelan owns Ibex, St. Johns, and Jarenz, all of BIEL's major lenders. What's the purpose of setting up all of these entities when one would have done just fine? To make it a little less obvious that BIEL was setting up her trust fund, IMO.
True, but IMO it's a pretty safe assumption to make.
Well, in truth his family made a small fortune during the dilution fiasco of 2009, giving hundreds of millions of shares to his daughter at a 90% discount to market value.
My question is why does he keep putting science in quotation marks? I'm assuming it's because he thinks that he and Andy are more intelligent on scientific issues than senior FDA management.
My guess is the FDA put the RecoveryRX 510k on hold until the rulemaking is made final. Simply put, if the rulemaking is finalized it would render the 510k approval for RecoveryRX moot anyways, as they would still be required to file a PMA.
Well, I think fundamentals always matter, but when the information is being so badly misinterpreted and misunderstood it's useless.
Also, if they have contracts in place for distribution with Walgreens and CVS upon FDA approval then that is most definitely NOT public information and should be disclosed through a PR. I would imagine that such talks would be conducted under a confidentiality agreement with those companies and they probably wouldn't be too happy about Andy talking about those discussions with individual investors. All IMO of course.
I think the point on the rejections depends on the exact question asked and the word-for-word response. If the question was whether or not the appeals have been rejected, well then the answer is probably no. But if the question was if their applications have been rejected, the answer is obviously yes for both 510K and at a minimum Allay's De Novo app.
While I agree that it is possible for BIEL to become profitable if demand for their product grows, I think it's incorrect to claim that the company is ignoring Canada. They have tried several times to reach the Canadian market, most recently via Greenwood, and have simply been unsuccessful. Whether that's due to poor marketing or simply a lack of interest in their products is up for debate, but they have definitely attempted to reach Canadian consumers.
Well, like I said this is their last chance IMO, for OTC approval. I have no idea whether they will or won't succeed, but I think they're fighting an uphill battle. GL.
Well, all I can say is that they've been meeting with the FDA on and off since at least 2009, and all prior requests have been rejected. Past results do not indicate future performance, but I have yet to see BIEL come out of a meeting with the FDA and state anything but great progress.
No, I never said they don't emit heat, that's not up for debate. What is up for debate is whether or not the heat emitted is the source of the beneficial effects. The part below is the key point from Walker's post
Yeah, I saw that, and BIEL's job is to covince them otherwise.
It simply isn't an option. They are diathermy devices and are regulated by the FDA. There's no way to backdoor their way onto the shelves unless they make fundamental changes to the technology, such as turning it into a TENS device.
Well, that may be their stance today, but it goes counter to all arguments regarding the benefits of PEMF in the past. It's always been stated that the EMF does something at a cellular level that facilitates healing. Maybe the changes they made addressed the issue.
Well, this is what was stated in the proposed rulemaking:
Thanks for the catch on the Allay/Acti switch. I corrected it in the post. I'll defer to you on the difference being the power output, but I will say that I went back and read several of BIEL's clinical studies and none of them mention heat as the possible mechanism of action. To me, this is kind of a hail mary on their part to get it re-categorized, but you probably know more about it than I do.
For medical devices the FDA usually only posts approvals. However in this case, due to the requirments of posting a response to the reclass requests in the federal register I think they'll be forced to post the decision quickly.
Here are the FDA facts as I understand them today.
The FDA denied the 510k applications for both Actipatch and Allay.
The FDA denied the De Novo application for Allay, which in turn means the Actipatch patch has been or will be denied as well since the technology is the same.
BIEL is appealing the De Novo rejection(s) based on the idea that the product should be in the Thermal diathermy category (IMJ) as opposed to the non-thermal diatermy category (ILX), which they've been categorized as for over a decade. This argument, IMO, is their last hope of getting it approved for OTC sales, and they're fighting an uphill battle.
Additionally they have a 510K application pending for additional Class III indications. This application is now a moot point due to the recent FDA proposed rulemaking requiring a PMA for all non-thermal diathermy devices. They likely aren't even looking at that filing.
As a result of the FDA proposed rule, BIEL filed a separate reclassification application that the FDA should rule on by the end of this month. It is likely putting forth the same heat mechanism of action argument as their De Novo appeal.
If FDA denies the heat argument, they are left with only one course of action for the U.S., and that's submitting a PMA for Class III approval. OTC sales will be out of the question unless something dramatic happens to the FDA's stance on these devices.
In summary, I think BIEL's in a very, very difficult situation with the FDA right now, and I think they know it which is why they are focusing so much attention on overseas business at this point. They have to convince the FDA that all prior PEMF studies are wrong and that the actual mechanism of action for the product is heat. That's a tough sell, IMO.
Well, the orchestrated pump yesterday was moderately successful. Guess what comes next...
Yeah, I saw them, but I'm nowhere near enough of an expert to know which ones, if any, could be used to support a PMA. Maybe all, maybe none.
They have done studies, but I don't know whether or not they meet the requirements for a PMA submission. I have read a few of them, and they generally involved a small sample size. According to the proposed rulemaking:
You said it better than I did, and in less words. Thanks!
Also, I think it's important to note that BIEL does not have to prove that the Actipatch produces heat, they need to prove that the heat produced is actually the cause of the beneficial effects. A lightbulb produces heat, but nobody is going to argue that it will heal a muscle pull. I have no doubt that they successfully proved that the temperature of the area was increased by the application of the patch, but does that actually provide the benefits or is it simply a byproduct? That's the challenge BIEL is facing. If you do a google search for PEMF and Mechanism of Action, you won't find any study that tries to argue that heat is the primary source of healing.
Well, if the FDA denies the heat argument, then the PMA would be required just to be approved as a Class III device again. I think it would be difficult for BIEL to get OTC clearance if that occurred as they have already been denied via the De Novo reclass request. I think any OTC approval hinges on BIEL successfully convincing the FDA that heat is the actual mechanism of action, something that PEMF manufacturers have argued not to be the case for years.
An orchestrated pump and dump campaign. At least they're including disclaimers these days.
Momentum already gone. Closing red today.
I agree. That's why I said that BIEL needed to be successful in their attempt to convince the FDA that heat was the mechanism of action otherwise they would be required to file a PMA.
They can today, but if the rulemaking I linked to previously is made final then all PEMF devices approved via 510k, like the Actiband would need to submit a PMA in order to continue marketing the device.
Here is the FDA's acknowledgment of BIEL's reclassification request.
http://www.regulations.gov/#!documentDetail;D=FDA-2012-N-0378-0004
It was filed right at the deadline, so hopefull they will get a response by the end of the month. Unfortunatley the filing itself is blocked for the public, but all other docs in regards to this proposed rulemaking can be found here:
http://www.regulations.gov/#!docketDetail;dct=FR%252BPR%252BN%252BO%252BSR;rpp=25;po=0;D=FDA-2012-N-0378
He's probably talking about the U.S. site, which was pulled after receiving the letter from the FDA.
Those are the top rated products, not top selling. Given that there hasn't been a new rating since July, I'd wager it's very likely the majority of those ratings were posted by investors, not users.
IMO, this reclass application in response to the FDA's proposed rulemaking is BIEL's last shot at FDA approval. If they are denied then it's down to a PMA which is an expensive and time consuming process. At some point it would be best for Whelan to sell the patents and stop wasting shareholder money. I do not think they will thrive overseas without the FDA stamp of approval, personally.
He clearly stated that recent 510K approvals made him feel that BIEL was close to achieving their goal, and provided a link to a non-comparable technology as proof. If I misunderstoond his intent then my bad, but I'm not sure how else to interpret his post other than to say an approved TENS device somehow means BIEL is getting closer to approval.
Well, here's the list of approved devices. I don't see any big names on the applicant list, but that doesn't mean some of these products weren't subsequently sold to big pharma companies.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
That's a TENS device, it's not comparable to PEMF.
Well, the filing says 60 days, which generally means calendar days unless they specifically state business days. This is the government however, so...
It looks like the FDA expects this proposed rulemaking to effectively kill the PEMF market in the U.S. altogether.
This rule would apply to all non-thermal diathermy (PEMF) devices, so any device currently on the market would need to file a PMA. Looks like, at this point, the FDA has determined that BIEL's devices are in fact non-thermal diathermy devices and would need to go through the PMA process. They do, however, allow for the company to attempt reclassification as described below: