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http://www.fda.gov/AdvisoryCommittees/Calendar/ucm346715.htm
Should have started over an hour ago.
Whoa, those were some sizable sells.
I don't know much about the market or the effectiveness on animals, which is why I haven't really stated an opinion on the vet market previously. You could be right and it could be a huge untapped market. I know people go out of their way to care for their pets, but I simply think that there needs to be broader awareness and acceptance of the technology among the population before a small company like BIEL can make much of an impact in that space.
On the other hand, people will buy anything off of QVC (like shock belts that are supposed to give you abs of steel) so who knows?
Well, aside from my personal opinion that the pet avenue is a dead end, Mary only has an exclusive distributor agreement for specific countries OUTSIDE of the U.S. And, according to BIEL's filing that agreement expired in February of 2012. Mary isn't the problem here. If you honestly believe that the pet patch is a viable product then the blame falls squarely on the shoulders of one Andrew Whelan. He is free to negotiate distribution agreements with any of the various pet product distributors in the U.S.
In addition to the related party transactions disclosed in Note 6, BioElectronics signed a distribution agreement on February 9, 2009 with eMarkets Group, LLC (eMarkets) a company owned and controlled by a member of the Board of Directors and sister of the company's President. The agreement provides for eMarkets to be the exclusive distributor of the veterinary products of the Company to customers in certain countries outside of the United States for a period of three years. The distribution agreement lists the prices to be paid for the company's products by eMarkets and provides for the company to provide training and customer support at its own cost to support the distributor’s sales function.
That was their initial rulemaking notice, but if you read further into the document you're looking at you'll find their new recommendation:
Summary
SWD devices are currently classified in Class III. In light of the information available now, the Panel will be asked to comment on whether SWD fulfills the statutory definition associated with a Class III device designation. FDA believes that these devices may be more appropriately regulated as:
? Class II, meaning general and special controls are sufficient to provide reasonable assurance of its safety and effectiveness
As opposed to:
? Class III, meaning
o insufficient information exists to determine that general and special controls are sufficient to provide reasonable assurance of its safety and effectiveness, and
o the device is life-supporting or life-sustaining, or for a use which is of substantial importance in preventing impairment of human health, or if the device presents a potential unreasonable risk of illness or injury.
There is no code or class for OTC. Currently there are no diathermy devices, be they ILX or IMJ, approved for OTC sales. If BIEL wants to be the first they are going to have to provide very conclusive data regarding safety and effectiveness which will likely mean multiple clinical trials with large sample sizes.
Ignoring their appeals requesting to be moved to the IMJ category, since we don't know where those stand, the most likely result of tomorrow's meeting is that the FDA recommends ALL ILX devices be classified as Class II with extensive special controls including additional clinical studies. I expect, although this is unclear, that even the devices previously approved via 510K will be required to re-apply for pre-marketing clearance since the FDA was very critical of the current reseach available to support safety and effectiveness of the products. Regarding postoperative edema, for which BIEL is currently approved, they stated:
Effectiveness for Postoperative Edema
There are only two RCTs, which assessed postoperative edema [9, 17]. Neither study used a validated endpoint for edema. The RCT for patients undergoing blepharoplasty [9] did not show a statistically significant reduction of edema in the eye. The RCT for patients undergoing foot surgery [17], showed no benefit for edema in the first 3 days following surgery, but a statistically significant change of edema when patients returned for suture removal. The absence of benefit in the first 3 days makes the reported benefit at suture removal of questionable clinical relevance.
Overall Conclusion
The body of valid scientific evidence is limited and the results of the available studies are inconsistent. Major findings include the following:
? The data reviewed are not adequate to demonstrate a reasonable assurance of effectiveness of nonthermal SWD for the broad indication of postoperative pain or edema.
? There is evidence that randomized controlled trials of a specific device for pain following a specific procedure such as post-breast surgery pain are feasible and can demonstrate a clinically relevant benefit.
? The absence of a benefit in studies of pain following procedures other than breast surgery is consistent with the expectation that each device and each procedure represent a unique clinical situation for which effectiveness would have to be supported by clinical performance data.
? There are no commonly used or validated measures of postoperative edema.
? Although the clinical studies were not designed to systematically capture adverse event information, the limited safety data do suggest that even low power SWD devices may cause injury if not used properly. The available studies are not adequate to establish a reasonable assurance of safety of SWD for the cleared indications.
Well, technically they fit into the category to which they are currently assigned, ILX. Based on the way the FDA has defined the categories any diathermy device that doesn't provide "therapeutic deep heat" belongs in the ILX category. No matter where they land they're going to have to complete some additional clinical trials I think.
Here come the buys...
Be interesting to see how it trades today and tomorrow. Although most should be aware that tomorrow's meeting does not directly impact BIEL's current filings, I'm certain there are some who are still holding on for the typical FDA PPS bump that BIEL receives any time something PEMF related happens. Looks like any run that might have occurred was effectively stifled by addtional debt conversions (my hypothesis, not known until Q2 financials are released). There were some nice buys at the open, but the selling pressure has mounted since then.
The shares were converted at the prices described in the financial statements and then sold into the market. Unfortunately there is no way to know who was buying them unless they show up on a form 13F for an institutional investor at some point, though that seems unlikely.
If you read the executive summary for the meeting tomorrow you'll see that the FDA doesn't feel there is enough clinical evidence to support safety and effectiveness, even for the indications already approved. I am talking about the ILX category here, which is where BIEL stands today. That document gives the first real insight we've had into the FDA's line of thought on these products, even if we've been pretty accurate in our guesses previously.
Also, if you read the introduction where it describes the difference between IMJ and ILX devices you'll see that BIEL is going to have a very hard time getting their device recategorized. Typical IMJ devices provide "Therapeutic Heat", which is defined by the FDA as:
Therapeutic deep heat is considered as a sustained temperature increase to 41 – 45°C [1] [2], which triggers blood flow to the heated area.
•The power, pulse duration and pulse rate of the device generates sufficient energy to raise tissue temperatures up to 1 degrees C in muscle tissue 3-5 cm below the skin surface This level of heating (greater than 0.3 degrees C) is physiologically significant. This clearly shows that the device produces an effective heat level.
It is physically impossible for the Allay device to heat any body tissue above 3 degrees C or to heat tissue more than 5cm below the skin surface.
That appears to be the case. I think best case short term is they get switched to IMJ and approved for prescription use. No matter what category they're in they'll likely need additional clinical trials for OTC.
I'm on my phone so I'm going to keep it short. Their device is not considered thermal right now. It's still ILX but their petition tried to argue it should be IMJ and OTC. My point is that they should have been arguing for class II for ILX devices since they don't know if their IMJ reclass appeal will be approved or not. They missed an opportunity is all.
Also I think you misread the summary as the FDA is recommending class II with special controls for all ILX devices. Whether or not the panel agrees is yet to be seen.
No. It means that every IMJ device currently on the market is available by prescription only. BIEL has to convince the FDA to change their category and then blaze a trail by being the first device approved for OTC sales. A daunting task.
I understand that. My point was that their reclass request to IMJ isn't in the bag so they should have put forth an argument for their current category to be changed to class II. Unfortunately they are so inept they embarrassed themselves and got scolded by the FDA like a child.
Well, that's why I've been saying this is an FDA or bust play and should be traded as such. If you think that BIEL management is ever going to be succesful with a global marketing campaign then you're hanging around for something much less likely than a short term run on FDA approval in my opinion.
Yes, we knew this meeting wasn't specifically about BIEL's approval request, however the classification of their current category (ILX) is obviously important to the company in the event their attempt to get it recategorized to IMJ fails.
The FDA is recommending reclassification to Class II with a bunch of special controls, including:
Clinical Testing – clinical testing must demonstrate a reasonable assurance of safety and effectiveness. Studies should include the following basic study design elements:
o Randomization
o Sham control group
Well-defined patient population, e.g. patients having a specific surgical procedure
o Well-defined SWD treatment parameters and device settings
o Clinically relevant validated measures of effectiveness
o Adequate power and sample size
o Appropriate statistical methods
o Predefined success criteria
o Systematic collection of adverse events
FDA believes clinical data are necessary for the following reasons:
? Existing literature do not conclusively demonstrate safety and effectiveness of the nonthermal SWD.
? The nonthermal SWD devices have a wide range of output parameters and treatment regimens (noted in Table 2) and the correlation with device performance is not clear.
? Given the subjective nature of the indications for use (postoperative pain & edema), there are not adequate animal models to be used in lieu of collection of clinical data.
FDA believes that clinical data are necessary to demonstrate reasonable assurance of effectiveness for all new devices.
Well, I knew that as well, but thought that BIEL might at least file something relevant to the topic to try and support the ILX devices being reclassed to class II in case their other petitions were denied. I was wrong.
Did you read the section where they describe the current scientific studies available to support effectiveness? They were very critical. It does look like the FDA thinks that the category should be moved to class II, but it looks like there will be quite a bit of additional data required to prove effectiveness, particularly for edema which is what BIEL is currently approved for.
Another interesting item from the summary:
Currently, thermal SWD devices are regulated as Class II devices, and have only been cleared for prescription use (product code: IMJ).
For those interested the FDA has now updated their website with the materials for Tuesday's meeting.
http://www.fda.gov/AdvisoryCommittees/Calendar/ucm346715.htm
The amateur nature of BIEL's management is on full display in the Executive Summary of Tuesday's meeting. Their arguments have been summarily dismissed.
Submission from BioElectronics Corporation
The request seeking a change in classification from Class III to II from BioElectronics Corporation propose that all SWD devices are thermal. They are proposing that their devices should be available with an over-the-counter (OTC) designation. Currently, thermal SWD devices are regulated as Class II devices, and have only been cleared for prescription use (product code: IMJ). BioElectronics is specifically interested in the OTC change as well as a change in classification to Class II for their devices for the indications of treatment of “relief of menstrual pain and discomfort and relief of musculoskeletal pain.”
The purpose of this meeting is not to determine what qualifies as thermal or nonthermal SWD, nor to recommend whether the existing prescription use devices can appropriately be used as OTC devices. OTC use of nonthermal SWD or thermal SWD has not been classified by FDA. These discussions are not applicable to the overall classification of the SWD device. Furthermore, the indications for use included within this request are outside the currently cleared indications for use; hence, they are beyond the scope of this classification proceeding.
I don't need to make up justification. History indicates an ever increasing share count. Looking at a 6 or 9 month period and ignoring the previous 3-4 years is biased sampling at its worst.
One more thing to keep in mind, the attorney approved financial report will come out next week on Tuesday the 21st. It will contain share counts. If everyone sees that share counts haven't changed, and they still believe its a scam and there is dilution, then I would suggest they file their claim with the SEC.
That's a ridiculous excuse and you know it. According to their financials they are making millions of dollars a year in net profits. For a company this small with effectively one product it wouldn't cost more than $25k - $50K for an audit.
And somebody just bought 1000 ($2) shares to raise it back up to $.002. Could be MMs completing larger orders that were only partially filled? I really don't know what prompts those tiny trades as I've seen them in a lot of pinksheets.
Lol. Not one can removed. Why is that not a surprise? Looks like they dropped off a few cases for the store to give a test run.
Unfortunately being a non-reporting pinksheet company means that substantiation isn't coming any time soon. You'll have to draw your own conclusion from the facts available. To me, it's crystal clear, but others will obviously interpret the information differently.
The product will be dropped after the pilot proves unsuccessful, just like the CEFCO stores in your avatar.
LOL. Yeah, I'm sure the manager was standing by to take questions on this pilot product.
Of course they did. How else do you think that the surges in volume correlate to the conversion of debt? They flat out tell you what they're going to do in the financials:
On June 18, 2009, the Company authorized to increase the number of common shares from 750,000,000 to 1,000,000,000, with further increases to 1,500,000,000 (November 2010), 2,000,000,000 in 2011, 3,000,000,000 in 2012, and finally to 4,000,000,000 in 2013. These increases are a result of the continued requirement to cover the potential issuance of common stock resulting from the conversion of debt to equity, and the vesting of nonvested share awards. The shareholders of the remaining shares to be issued upon conversion or exercise of equity instruments are likely to promptly sell those shares into the public market. The resale of these shares could have a negative impact on the stock price, and these conversions would have a dilutive impact on our shareholders. As a result, our net income per share could decrease for future periods, and the market price of our common stock could decline.
For those interested, the Whelan family and friends converted $231,452.60 worth of debt into 251,018,609 shares in Q1 at an average PPS of $.000922.
Those shares were then sold into the market at prices ranging from $.0015 to $.005. To be conservative let's assume the average sale price was $.002. That means insiders made roughly $250,000 of profit on the shares sold. That's on top of the 8% interest they're earning on those loans. Lending to BIEL is a pretty good gig if you can get it.
If/when they execute a reverse split will be dependent on how the PPS reacts to events over the next few months. If dilution and FDA events force the PPS down to a level that BIEL cannot effectively fund operations through the issuance of shares then they will have no choice but to conduct a reverse split. On the other hand, if FDA news is favorable the and PPS climbs then there will be no reason to conduct one in the near term.
I don't really want to say I told you so, but earlier in the year when the volume was spiking I said it was likely debt conversion and was roundly shouted down by the board's regulars. If they continue to convert debt throughout the year as opposed to issuing shares directly for cash then it will have a much bigger impact on the PPS.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=84787954
During the three months ended March 31, 2013, IBEX converted $58,929 of the Revolver’s outstanding balance and received 78,571,428 shares of the Company’s common stock at a conversion price of $0.00075 per share. There were no debt conversions for the three months ended March 31, 2012.
The balance of the Revolver as of March 31, 2013 and December 31, 2012 was $1,535,981 and $1,325,947, respectively. During the three months ended March 31, 2013, the Company received an additional $251,000 in proceeds through the Revolver to fund operating expenses. If converted, the Revolver debt at March 31, 2013, at the conversion price of $.0012 per share represents 1,279,983,562 shares of common stock.
Even the share numbers shown in the financial reports are suspect. According to the Wyoming SoS there are 5 million preferred shares authorized and yet Item IV of the annual report states there are 500 million preferred shares. Yet you scroll down a bit to Item VI and it says 2.5 billion common shares. None of those match what are registered with the SoS.
http://www.otcmarkets.com/financialReportViewer?symbol=BBDA&id=102494
https://wyobiz.wy.gov/Business/FilingDetails.aspx?eFNum=139156196253141251029028070039008175089079194136
So which is it? 5 million preffered, 500 million preferred or 0 preferred?
Good thing for his racing hobby that he is none of the things you listed.
Not a joke.
FACT: The CEO has issued shares in excess of the authorized amount listed on the Wyoming SoS site in the past.
FACT: VFIN is the primary MM used for penny stock dilution.
Draw your own conclusions.
BW's got some more shares to sell. Must be racing this weekend.
Again, that's the easy part. Check out the following link and take a look from section 3 onwards:
http://nysemanual.nyse.com/LCMTools/PlatformViewer.asp?searched=1&selectednode=chp_1_2_2&CiRestriction=102&manual=/lcm/sections/lcm-sections/
Independent directors, annual meetings, shareholder approval requirments, etc...
Seriously, it's not realistic in any way for this company or the new entity to get themselves listed on a major exchange any time in the foreseeable future.
Sorry, that's just funny. Thanks for the morning laugh.