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I hope it does for those holding.
What they state and reality don't always coincide. More than likely it's a loan up to $500K, with less available currently based on their current metrics. Like I said, I'll wait to see if they provide details in the notes to their financials.
Hmmm...looks like this one might be different afterall. The EX-IM bank started a pilot program in March of last year for small business lines of credit:
http://208.68.149.50/products/GCEFacSheet.pdf
However, I'm not sure how much they actually have available under the line since it's capped based on a % of their exports from the previous year, or a % of their net current assets as of their last financial statements.
http://www.ibt-articles.com/absnet/templates/trade_article.aspx?articleid=485&zoneid=2
http://www.exim.gov/smallbusiness/smallbusprod/Global-Credit-Express.cfm
The maximum loan amount is $500,000, and the maximum term is 12 months. The maximum loan amount is calculated as the lesser of: 50% of the borrower's direct and indirect exports in the previous year; 90% of the borrower's net current assets as per their most recent financial statement; or $500,000. The loan amount can be drawn in full or in part at any time during the term of the loan, with a minimum drawing of $10,000. The loan can be renewed annually, but the borrower must again meet the approval criteria at the time of renewal, including the small business requirement.
I'm pretty sure this is a renewal of the same line they've had in place since 2009, but it's good that they got it renewed I suppose.
I think Class II with special controls is a given at this point, although I suppose there could have been arguments made for Class III. However, if they impose the special controls that were recommended in that summary then it's not going to be a whole lot different than what is required for Class III. They will be required to present clinical studies for each indication.
Also, I don't think BIEL is at all confident that they have the necessary data to support an approval at this time. They stated in their PR that if they are required to submit additional clinical trials that they believe their molar extraction study will meet the criteria, however that study isn't even completed yet. If they thought their existing studies would be adequate for the FDA to approve the device then I'm sure they would have indicated that in their PR. Again though, if the FDA goes the direction they were leaning then that approval would be specifically for that procedure, and they would still need more data for additional approvals.
I am looking forward to reviewing the transcripts as well to see if there was anything extraordinary presented that might have persuaded the FDA to impose less restrictive special controls. I'm also hoping that the transcript is phonetic so that I can read Whelan's speech:
FDA: "Mr. Whelan, please present your case."
Whelan: "Uhh.....what? Oh, yeah, uhhhhhh, does that mean we are approved for over the counter sales now?
FDA: "That's not the topic up for discussion today. Do you have something to support the argument for ILX devices being moved to Class II?"
Whelan: "zzzzzzzzzzzzzz"
FDA: "Mr. Whelan!"
Whelan: "Huh? Ummmm...heat. Our device produces heat...ummmm wait...I think it does, right? Wait, that was yesterday...<mumble, mumble>ummm, something about nerves and stoking a resonator or something."
FDA: "Again Mr. Whelan, that topic is not appropriate for this panel. Do you have anything else to present that is on-topic?"
Whelan: "zzzzzzzzzzzzz"
FDA: "Okay, next up is the CEO for Ivivi Technologies..."
If you look at the financials you'll see a lot of debt is coming due this year. Last year they extended some of the maturity dates, but it looks like they're cashing out this year so I don't think much of this dilution is generating cash for the company. How much would it cost to do a legitimate marketing and distribution campaign in a foreign country? I have no idea, but it's likely dependent on their distributor and how the costs would be split between the two companies.
Yeah, 20 million shares sold at or below $.0018 today. Not a whole lot to hold onto in the near term. Of course unexpected events are what cause the big runs for which gamblers are hoping.
He's been talking about audits for 4 years and not one 3rd party has gotten a look at those financials yet. It's his responsibility to prove that he's sincere this time. Until that point there's no reason to believe this time is any different than the others.
Not true at all. There are lots of small business lines of credit available to non-audited companies. You do, however, have to be willing to open up your books to the bank and we know that's not something BW is going to allow.
Also, the company has to have assets on which the Bank can put a lien. BBDA has none.
Stick a fork in this stock. The P&D has run its course.
Well, the doctors conducting the Allay study were a plastic surgeon and Joe Noel's old girlfriend, so a shoddy study wouldn't surprise me. The Plantar Fasciitis study was much better designed and reported, but the shortcomings of the study were described in the conclusion and while being a good pilot study it wasn't conclusive. Plantar fasciitis could be a very strong market for these products if they can get it approved and accepted by athletes. The only feasible treatment for PF currently is rest or pain killers and athletes would kill to have an alternative.
I've read through the Allay study and I can't find anywhere in the study that they assessed Analgesic use. It states:
Patients are to take, if needed, any medications that they might normally take for pain relief during a normal menstrual cycle.
Possible, but there's likely a lot of dilution between now and then. GL.
There is a difference between negative and realistic. Read the docs.
There is absolutely zero percent chance that the final decision issued by the FDA will include OTC clearance for any of these products. Can it happen one day? Sure, but not until they conduct additional clinical trials, and lots of them.
You're correct that limiting the choice to one of the two was unfair. He's clearly both.
He's either lying or stupid, you pick which one you prefer.
“I expected to end capitalization at around 2 billion shares; we went a little over due to difficult market conditions but we are now at a point that revenues and profits will fund our operations from this point forward,” said BeBevCo CEO Brian Weber. “Additionally as detailed in my video conference back in March, we will begin a systematic buyback of our stock later this year or early next year which will increase the value of the stock for our shareholders. We are grateful to our loyal shareholders for staying with us through the capitalization process. Between the deals we have in the works and the growth we have achieved and expect to sustain well into the future, the stock will no longer be a necessary capitalization tool,” said Weber.
We have a self-imposed cap of 2.4 billion shares outstanding and a total authorized limit of 2.5 billion shares.
The lawsuit would get nowhere. The products are not owned by BBDA, thus if he claims that running the shell is no longer viable there's nothing anyone can do about it. Pinksheet companies go belly up all the time.
Breaking your word is not lying? I'd like to hear your definition.
No, the board is pointing out the fact that the CEO has once again proven to be a bold-faced liar.
Generally speaking equity financing is more expensive than debt financing. That's why most analysts like to see a balance between the two. Debt financing for a non-reporting pinksheet company without audited fins is basically unattainable, however, except for the death spiral kind.
More importantly there is no incentive for him to buy back interest in BBDA. If he ever wants to take the company private he simply bankrupts the shell and takes the trademarks and other assets (owned by DLR and other entitites) and walks away.
What's impressive is that they got a shot of both of her fans at the same time.
Plus, why in the world would he need to buy out the company in order to go private? All of the trademarks and assets are owned by other entities under his and Daisy's names. All they have to do is shut down the BBDA shell and all of the stuff that matters is theirs to do with as they see fit.
Wait, isn't this company raking in $500K a quarter in profits? Why would they possibly need to raise the AS when they're swimming in net income? Nothing to see here folks, everything is on the up and up...
Also important to note, although we won't know for sure until the final ruling is published, is the comment from the summary below:
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.
The problem is the efficacy isn't as proven as you guys seem to think, at least not from a scientific perspective. It may be proven to you by personal use, but the clinical studies vary in their reports of effectiveness and are of questionable scientific merit. So, widespread acceptance by doctors or even vets is going to be slow until better clinical data is available.
Looks like it takes a couple of weeks for the FDA to post minutes from one of the advisory committee meetings. I'll be interested to see what was said at the meeting yesterday.
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Pulmonary-AllergyDrugsAdvisoryCommittee/UCM350491.pdf
They got their 510K approval by stating it was substantially equivalent to a device that was approved prior to May 28, 1976. Devices approved prior to that date were basically "grandfathered" in:
http://www.accessdata.fda.gov/cdrh_docs/pdf2/K022404.pdf
A postamendments device is one that was first distributed commercially on or after May 28, 1976. Postamendments devices that FDA determines are substantially equivalent to preamendments Class III devices are subject to the same requirements as the preamendments devices. FDA determines substantial equivalence after reviewing an applicant's premarket notification submitted in accordance with Section 510(k) of the act. Postamendments devices determined by FDA to be not substantially equivalent to either preamendments devices or postamendments devices classified into Class I or II are "new" devices and fall automatically into Class III. Before such devices can be marketed, they must have an approved premarket approval application or be reclassified into Class I (general controls) or Class II (standards).
I'm sorry to say but Andy doesn't care about your anger or your email. He's going to run the company as he sees fit and doesn't give a damn about the common shareholders.
No proof of your claim that Koma is on Walmart shelves since all of the pictures we've seen show that it's only in temporary displays as part of the pilot program.
Marley's has secured permanent shelf space and is available via Walmart.com. Koma has accomplished neither. It will be dropped once this test run in complete.
Next subject?
Or he sold them to his buddy Jared who dumped them on the market. Yes, there's no proof, but if you're going to take the financials at face value then it is obvious those 100 million shares were sold in a private placement, not on the open market.
Looks like we're on the same page, lol.
Definitely possible. Fuente seems to have a good grasp on the FDA and science part, so maybe he will weigh in later. I think the FDA is going to have a hard time taking BIEL seriously if they can't be consistent with their claims.
It's entirely possible that I'm misunderstanding his statements, but it looks to me like he is now describing a non-thermal mechanism of action when mentioning "sensory nerve activation" and "stochastic resonance". Heat may be a byproduct of stochastic resonance, but I don't believe it's the primary source. I am no scientist, but the little bit I've read about SR did not mention theral effects.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2660436/
I am interpreting this as a switch from a thermal mechanism of action to non-thermal. Again, I could be wrong.
If the company was really $500K in the black for the quarter, then why the need to dilute at all? Oh yeah, because the revenue numbers are made up. There is no way this company is making big profits and that's the reason they will NEVER let an independent auditor review their books.
Oh, and the balance sheet still doesn't balance. Still a share selling scam to fund the CEO's racing hobby.
LOL. I haven't checked back here in a while. When is Bieber taking this stock TO THE MOON!?!??!?!?!?
Okay now wait a second here...
Recent studies have demonstrated a clear mechanism of action for pulsed shortwave diathermy. Whelan was assisted in the explanation to the panel by a researcher from the State University of New York in Binghamton, Sree Koneru. Working at the Department of Bioengineering at the Watson School Koneru's experiment demonstrated the activation of motor nerves with non-thermal RF diathermy.
The hierarchy of nerve firing tells us that the initial response to the stimulus is sensory nerves activation. We now know that BioElectronics devices stop pain though well established and understood electrical nerve stimulation. The effect is achieved through a proven physical phenomenon of stochastic resonance. This demonstrated physiological mechanism of action is a major breakthrough for shortwave therapies that are considered non-thermal by the FDA.
Appeals on 510k’s 091817 and 092931 are predicted on classification IMJ not the “non-thermal” ILX code. We are not petitioning for a non-thermal classification. It is our assertion that over 30 years of research has produced no convincing evidence of any non-thermal effects with RF therapy. It is now the scientific community’s widely held consensus and the Agency’s that there are no physiological effects from shortwave RF therapy that are not thermally related; that is, there are no non-thermal effects of RF exposure.
I still don't understand what he's expecting to present. If he's going to try and prove a mechanism of action then he's wasting his time because that's not the purpose of this meeting and hasn't been supported by the research currently available in the FDA's system.
Big volume early today. I hope the family doesn't use today's meeting as an opportunity to convert more debt.