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What's the case about? The link is there, why are you asking me? I clearly stated I haven't paid to get more info off the clerk's site?
https://www.clerk-17th-flcourts.org/Clerkwebsite/BCCOC2/OdysseyPA/CaseSummary.aspx?CaseID=7155410&hidSearchType=party_case&DisplayCitation=no&CaseNumber=CACE13024037&SearchType=
Call the clerk of the court or look up the plaintiff law firm and call them personally- their name is listed in plain English.
What's it about? It says on the clerk site, "Case Type: Contract and Indebtedness". You have a post on here who said, "they have read it" so ask them. How, or when they "read it" and even did that- who knows?
What's it about? I don't know? Read the information, make phone calls or send emails if you want to know? It's posted on a public, duly elected, clerk of a Florida court site, the 17th circuit of Florida and that's a simpleton fact. Others on here want to attack based on that, want to imply based on that, want to accuse based on that- but it's listed there, and that's a simpleton fact.
What else is there to know? I don't know? Figure it out? I'm not some legal source of info?
"you have an individual such as Dr. Samuel Ahn, distinguished practicing cardiologist, who keeps buying more shares in this company."?? Where, when? Prove it? It's the opposite- he's getting granted options all the time. Options are GIVEN to you, you don't "buy" them. He's also getting paid back at interest and also via share grant blocks. What "buying" of shares - prove it.
Why does someone stick around? How bout they just more than tripled their own salaries- one of them to a total compensation of nearly $1 MILLION per yr. You think a "couple of phone calls" lands that kind of coin? The other boosted to over $300K a yr- with a masters degree from an average school and under age 50. Again, you think a "couple of phone calls" generates that?
Further, cite a single post that said "scam" as you stated? Posting that they are low on cash, which is pure REALITY is not saying it's a "scam". Posting that MIRROR appears to be going nowhere and that a "blog" added nothing to a 10-K is not saying anything is a "scam"- prove otherwise using facts.
The only site I'd rely on 100% per that alleged suit, is the clerk of the court site, run and maintained by official govt. agency of the court system.
Here is the link:
https://www.clerk-17th-flcourts.org/Clerkwebsite/BCCOC2/OdysseyPA/CaseSummary.aspx?CaseID=7155410&hidSearchType=party_case&DisplayCitation=no&CaseNumber=CACE13024037&SearchType=
Broward County Case Number: CACE13024037
Case Type: Contract and Indebtedness
Incident Date: N/A Filing Date: 10/28/2013
Court Location: Central Courthouse Case Status: Pending
Magistrate ID / Name: N/A Judge ID / Name: 13 Haury, William W., Jr.
Sharon McQuillan, et al Plaintiff vs. Kristin Comella Defendant
It's listed as a 100% real suit, has a judge assigned, a case number, etc. The speculation on the video linked in the post, is that it's a scan of the initial filing probably. The Broward county clerk of court site, appears to have a service in which you can pay a fee and probably see the documents if they are on file there. I haven't paid or care to pay- I think it will update in due time. The plaintiff named attorney who is listed as retained is the real deal- you can look um up and their web site, they're a serious firm with a serious track record and are located in Florida as would be expected.
Where that will go- who knows? But, she's an officer of the company and those companies named on the Broward clerk site as plaintiffs indeed are all related to places she works/worked and also have deals, I believe in some form or another with BHRT. Certainly Stemlogix does- that was in prior PR and I believe 10-Q's, as well as, Ageless I believe.
Have to wait and see- it's civil litigation which can take a long time to move along (filed 10/28/13 is only 5 months or so). I found it interesting in the 10-K that they didn't mention anything under the litigation area? Although from that clerk site, she appears named as an individual- so maybe that's why? But usually, when you're an officer of the company- I'd think that'd fall under the 10-K or similar "litigation" section?
Who knows- that's just my opinions from reading the Broward clerk site. But that's an official, govt run site of the court- so to me, it must be legit to one degree or another. Wait and see I guess.
What's interesting too- is the verbiage above the compensation table isn't even correct as far as I can tell- which makes me wonder who edits/reads the 10-K before they put it out?
PAGE 71, 10-K above the compensation table says, "The following table sets forth, for the fiscal years ended December 31, 2012 and 2011, the aggregate compensation awarded to, earned by or paid to our Chief Executive Officer and our two most highly compensated officers (other than the Chief Executive Officer), who were serving as executive officers as of December 31, 2013, or the Named Executive Officers."
BUT, then the table goes on to list the 2012, 2013 compensation? The verbiage above looks old- as it says 2012, 2011? Doesn't make any sense to me?
Oh well, not surprising to me. IMO I think the table and verbiage are mis-matched. Like they updated the table to show the bonuses and new base salaries given in 2013, which as far as I know is fiscal yr 2013, but the verbiage says 2011, 2012? I've found other areas in the 10-K just like this- old language carried over going back clear to the prior 10-K, lines with verbiage that seems to make no sense or reference things incorrectly, etc. It seems like a pretty important document to have errors in it. A typo of a word I can see- but mismatching the header of a table to what's in the table? Oh well- again, that's my opinion and take on that page 71 compensation table. Read it yourself- maybe I'm wrong.
Any way I slice it- it comes up BIG SALARY INCREASES and BONUSES to me- which rubs me wrong when cash is tight and we were just told that thee major trial is probably held up due to "funding". That's my take and mine only.
10-K, PAGE 71, "Item 11.
Executive Compensation.
Summary Compensation Table
The following table sets forth, for the fiscal years ended December 31, 2012 and 2011, the aggregate compensation awarded to, earned by or paid to our Chief Executive Officer and our two most highly compensated officers (other than the Chief Executive Officer), who were serving as executive officers as of December 31, 2013, or the Named Executive Officers."
Then read the table- it lists Tomas total compensation as follows:
2012 was $247K base salary + ZERO bonus + $100,000 option = $347K
2013 was $391K base + $375K BONUS + $170K options = $936K TA DA !!!
Almost a TRIPLE in compensation- not bad, eh?
Comella was:
$159K base + $125K bonus + $82K options = $366K for 2013.
Her 2012 total was about $105K.
So that's a nice TRIPLE or so for her too.
(1)
On August 1, 2013, Mr. Tomas and Ms. Comella received $375,000 and $125,000, respectively, promissory notes for bonuses awarded. The promissory notes bear 5% interest per annum, unsecured and are due on demand.
(2)
On August 1, 2013, Mr. Tomas and Ms. Comella were granted 10,000,000 and 5,000,000, respectively, options to purchase the Company’s common stock at $0.01576 per share for ten years, vesting annually over four years.
(3)
On September 1, 2013, Mr. Tomas, as a member of the Company’s Board of Directors, was granted 400,000 options to purchase the Company’s common stock at $0.01654 for ten years, vesting immediately.
NOT A BAD GIG when you're bleeding cash and using ASHER and just doubled the outstanding shares in less than a yr, and can't give an update on MIRROR, your flagship product/phase III trial due to apparently "funding issues", eh? That's my opinions of course- but it's all there in black n white in the ole 10-K just released. Didn't rub me the ole right way. But hey, that's just me. Like it, buy, sell, hold - all per your own due diligence and again, good luck to all.
And as fast as it went to .08 it went back to about .04, then below that, then pumped to about .06 again, it then back to .035 yesterday and today. You think this is "normal" trading? It has all the hallmarks of a classic, pump n dump IMO.
The run to .08 was based on nothing - no real news of any substance IMO. Yet the chat boards lit up like Christmas trees preceding it, as did Twitter and PR and other outlets. Have you ever read details of how someone like "ASHER" does what they do? Ever read a classic, pump n dump described by credible investing sites or people who have worked the inside of these places that do um? Did you see how the spread opened up on "buy" orders, small $100 or so orders taking 5% or more spread to fill, as it began to move up sharply? Then, once the peak was reached for about a split second, it was tanked hard to the downside, so fast you couldn't blink and if you had sell orders in, they'd never get a fill at .08 as you tried to catch a falling knife.
To say this is all "cool" and no biggie and all is naive IMO. Look at about a 2 yr chart, you can plot the pump n dump cycles like ducks to water. Don't think Asher and others will unload this coming up? Well good luck to you. My 2 cents, it's gonna drop so hard, so fast one day (when, I don't have a crystal ball?) but if the past "cycles" are any indication, it hangs here a few weeks or so, then it starts the downward track back to penny-ville.
There is nothing new in that 10-K to indicate anything different IMO. Mirror is stalled by all facts/reports, versus hype. Cash is low and desperate as always, they doubled the outstanding shares from 200 million to 420 million or so in less than a 1 yr period (if they can't dump shares anymore, if that day comes, it's lights out- and always remember, they already defaulted on a key loan once which created "Northstar"), the sales being boasted about were noise level of about $5K a month- not even a micro dent in their cash burn, the CEO just boosted his salary/compensation package to near $1 MILLION annually and Comella also got a big boost and bonus awarded- all as they're bleeding cash and not even moving their flagship trial forward or progressing on the key items they boasted about in past PR- and that's not a problem?
To me, it smells of a huge problem. Boosting compensation as they're bleeding out cash and using the worst financing a company can survive on? AND getting "bonuses" too boot? Bonuses for WHAT? For having the main trial appear to go nowhere, for the stock spending most of the yr in the 1 to 2 PENNY range, etc?
Now another "study" being announced today- I googled for that "doctor" and all I get is references to his office location and practice. Not that he's even got a web site, or has any expertise at running clinical studies, or is published, etc- just a big google goose egg. AND it's being done outside FDA and is, in typical fashion, IMO so carefully "worded" you have to parse it down- as in, " The study will enroll up to 100 patients". You see that wording "up to"? You know what that means? That means between ONE and 100. If they enroll ONE patient- then they've met the terms of the PR, stating UP TO 100. Very carefully worded. A more typical wording, IMO would be, "The study will enroll a MINIMUM of 25 patients and may enroll up to 100 if needed". See the difference? They've made it so that if ONE patient is enrolled- then the PR is truthful. As posted earlier- it's "word-smithing" IMO. Further, it says it "study has been reviewed and approved by the Institutional Review Board (IRB) of the International Cellular Medicine Society (ICMS)." Well, look that group up, they, per their own wording on their web page are for "outside the FDA" or something to that effect. They also were FDA audited not to long ago, and written up on a bunch of stuff.
http://www.cellmedicinesociety.org/physicians/irb/415-fda-audit-findings
http://www.cellmedicinesociety.org/attachments/415_FDA%20483%20-%20ICMS%20IRB%20-%2019%20June%202012%20(redacted).pdf
It appears to be nothing more than some self organized "group" as I see it- and largely, again, seems to be designed to work outside the U.S. or outside the rigorous requirements of the FDA, again IMO from reading their own info.
From their site:
"Audley went on to express concerns over the FDA’s recent activities with regard to point of care treatments, stating, “While we do not dispute their regulatory role, we are concerned that FDA is trying to exert an influence over the practice of medicine by establishing authority over what studies an IRB can approve. "
So, again, another PR about another "undertaking" and as usual it's "vague" at best in my opinion. Some doctor is going to do a clinical "study" of degenerative disc now, and "enroll" "up to" 100 blah, blah, blah. And this will lead to what? When? How? It's going to be funded how? Expected results when? The doctor they named has what published background in clinical research, etc? Just vague as can be IMHO, and typical "PR".
Look at the financials on Cardio3. Their R%D to SG&A is about 1 to 1 or better. BHRT spent almost 4X their R&D budget on paying themselves + the rented suite and whatever else you pay for in a 4 or 5 person company- most going to TWO people (25% of the general SG&A went to Comella and CEO from what the 10-K indicated, anyone can do their own math, crunch the numbers, but that's my take from looking at it). $600K lousy bucks went to "R&D". The cost structure, especially if you're in cash-tight, tough times to me is totally lopsided. Most CEO's and other Sr Mgt take pay cuts, or forego pay for a while if the company is bleeding cash and in tight straights. Read the compensation section of the 10-K for a good hoot.
My opinion like others, and it's mine only, is it smells bad. That blog today, was a, "You gotta be kidding me" type event. All this, "email the CEO, he'll tell you" and then, "There's gonna be a blog update, it will all be in there" and then poof, the big blog comes out and we get the War and Peace Vol II version of the happy story about BHRT, with MIRROR buried deep, somewhere in there, so hard to find, it took a couple of reads to even find it. A lot, I think are insulted by the whole thing. Another post stated continually emailing asking for specific clarification of financial questions-vagaries, and those somehow always go un-answered according to that poster.
So, big deal they blew it to .08 for a micro second and then dumped it just as fast. They took it to .06 not that long ago, and it was back at a penny not long after that. It's a "trade" at best IMHO, it's no longer an investment. It's looking more and more like classic penny-ville IMHO. Just classic. Just the salary/pay package boost to near a Million a yr, that alone pretty much does it for me. All I need to see and know. The "smell test" is no longer passing per my standards. My opinions only - anyone else, fall in love with it as you like, buy a ton, hold, sell- whatever, it's a free country and a free market. Good luck to you all.
"wordsmith-ing". That's one of the best "terms" that comes to mind. Yes. IMO that is the "word" I was looking for too. That's the "smell test" I'm getting. Again, just my humble opinion.
But man, what a long winded, long worded, seemingly "crafted" statement about a shmattering of stuff, while seemingly dodging what everyone appeared to think would be a simple, MIRROR update? It was like the 7 plus yr re-hash since time began of BHRT? Made no sense to me whatsoever. I used the search function in my browser to FIND the word MIRROR. Honestly. That's how buried it was in that long read.
Oh well. Didn't excite me or answer anything I was looking for. But that's me. Others appear "excited" about it, I guess. "A blog"? Oh well.
Thoughts? It says NOTHING different about MIRROR than what was just in the 10-K. In other words, there is NOTHING known about an "update" on MIRROR at this point IMO. Nothing.
Last "update" then was July last yr, and ONE patient was "enrolled". It appears to be going nowhere. That is all that is known at this point, again, my opinion but the 10-K and now this "blog" of all things, seems to back that up. If there was more information and important progress, it'd be blasted out in 2 seconds in Pr's all over the place, again IMO.
Other than that, "blogging" about stuff going clear back to Marvel and what not? 4 to even 7 years ago in some long written "re-cap"? Why, for what purpose? After the 10-K just gave the financial realities and what is going on TODAY or in the last few months? It's like a big sales pitch/re-hash to me, and MIRROR is just buried in the clutter of it and then gets a line or two, saying something about, "it will depend on funding"?? Doesn't mean much to me, IMO.
All the other "new" stuff, essentially says to me, "we're going back to square one stuff all over the map- in fields that are not the "heart" and just tossing stuff all over the place"? Why? Is this a grand new business plan? If you can't fund your flagship product to completion, then WHY start up more and more, what, a dozen things (I'd have to read and count each one) that will all cost money IF they ever even move from some doctors office "investigational" level at all? Why? What money is going to pay for all that "stuff" as your flagship product, just as it did with Marvel, sits parked on the side-lines?
It makes no sense to me. How can a few people possibly be doing all this "stuff" spread all across many continents now and with very little money? How? It smells of "no plan" or just "toss stuff out there" to me- and that is only my opinion. But it all seems vague again, scattered, no focuses plan, more and more "medical tourism" and "off-shore outside the FDA" type stuff.
I just don't get it or see where it's all supposed to be going anymore at this point? When you have very little resources- as in money and people, my opinion and experience at watching successful business is, is you FOCUS and NARROW down to your core competencies, not scatter broad and shot-gun into everything under the sun? That's my opinion and 2 cents on it. I got nothing from the "blog". The 10-K says the real story IMO. It's all about cash/money and eeking out enough to limp along IMO. That's all I got. Mirror seems to be a "barely mention" now, and MIRROR IMO was supposed to be "it", the end game. Oh well, some may find a "blog" to be exciting or whatever, I see it as similar to a "PR" but even a notch below it. It's not binding as far as I know, it doesn't even contain a SEC disclaimer at the bottom as a PR would/does. It's just someone "blogging" IMO- something to read and take what you will from it. Doesn't excite or interest me in the slightest. I'm not aware of most, if any, listed companies using "blogs" as a way to send out official company or corporate communications? I could be wrong, but not used to seeing it at all? My normal experience, is official CEO or CFO or other company official communication comes through press releases, SEC doc filings, or in formal "talks" where someone, say, like Apple invites the press to reveal/release a new product- but I believe in those events they are very careful to not make financial claims or disclose info other than "revealing" the new product. All other items like sales projections or revenues, as far as I know, are typically done on the formal conference call after say the 10-K is released, where investment and financial press are allowed a Q/A session with Sr. Mgt and it's "on the record" and even then, they often refuse or do not answer particular questions, other than in generic form.
My 2 cents.
"but I don't recall announcements of interim enrollment numbers for Angel either."??
It was FIVE PEOPLE? Wow. Announce when 2.5 were enrolled? It was a phase I. What was there to "update" - the time it lasted compared to a phase III, and the complexity of a phase III is totally comparing apples to oranges IMO. Two totally unrelated events, again IMO.
"on the 10k from LAST YEAR!!!!!!!!!!!"??
The 10-K included "updates" that went ALL THE WAY TO MARCH. So that is incorrect. The "financing" updates for example, went right through the end of Feb, 2014 in the 10-K covering LAST YEAR !!!!!!
"blogs"? Don't mean much to me, that's my personal opinion. Look at the "blogs" about MIRROR and now the "reality" of the 10-K? Blogs IMO are just that, "blogs". The 10-K is the legal document and SEC document. Blogs- if some find them exciting or whatever, good luck. I'll stick to the SEC documents for sources of information on what is happening in the company. I prefer a signed, SEC filed, audited document in my opinion. I can't even remember how many "blog" and "PR" statements have been made, that I can never find again, or never amount to vast claims, when I search for them later in the 10-K or 10-Q? The revenue was $5K a month approx. in the 10-K, any other claims about how vast it "will be" is just speculation. Ever read the SEC disclaimers at the bottom of every PR or similar?
"Forward-Looking Statements: Except for historical matters contained herein, statements made in this press release are forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "to," "plan," "expect," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements.
Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Also, forward-looking statements represent our management's beliefs and assumptions only as of the date hereof. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.
The Company is subject to the risks and uncertainties described in its filings with the Securities and Exchange Commission, including the section entitled "Risk Factors" in its Annual Report on Form 10-K for the year ended December 31, 2013, and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2013. "
"Unbelievable. She completely dodged our main question".
YEP. That's exactly all that was in there, IMO too. Couldn't be more vague or scatter-shot IMO. It was almost like a political speech or something, again IMHO- saying almost nothing, in how many words? Wow, is all I can say after reading that. What was the point of releasing all that verbiage after the 10-K? I don't get it at all. Not in the slightest and that's my opinion.
" Now that institutional investors have garnered interest. All of the training and new revenue streams, "??
Where, when, who? What "institutional investors"? The 10-K showed DILUTION shares being sold via the same old avenues such as Asher and the Greystone equity draw-down line.
There was about $5K a month TOTAL in sales listed in the 10-K, from ALL sources- the main one being catheters and very little from anything else.
Anything else is pure speculation at this point. The 10-K included a cash and "financing" update right up through the day before it was filed and there was no "new" anything in it- other than Asher being used right up until as late as Feb 19, 2014.
Pure peculation versus what was just printed in the SEC filed, legally binding, audited 10-K?
My opinion? I'd hardly call Cardio3 BHRT's "closest competitor" or an apples to apples comparison? They're in Europe and listed on the major stock exchange there. They have over $30 million (U.S.) in cash as of about right now. They have a CEO who is a physician and has a long track record at Guidant (think heart stent biz acquired by Abbot and I believe now merged again with Boston Scientific among other things- I haven't followed Guidant in a while, but know them well from back in the day), their VP of R&D is a Ph.D. in molecular biology among other things, etc. Their lead product candidate is linked to research coming out of the Mayo clinic- one of the top heart facilities, top medical facilities on the planet.
They claim in their latest 2013 equivalent of a 10-K to be the world's first and leader: "Initiation of CHART-1, the world’s FIRST Phase III clinical trial in regenerative medicine for the treatment of heart failure"
- THE WORLD'S FIRST, and their phase III is actually moving along with major updates posted all over, via many sources. Mirror? We don't know other than "one enrolled" as of July last yr? Cardio3 also has a couple of pipeline items that are more pharma/drug type products they're working on for heart related issues.
So, hardly a comparison in my opinion. Lots of cash, listed on a major exchange (listed on NYSE Euronext Brussels and NYSE Euronext Paris regulated markets.), a Sr. Mgt team that appears to have strong medical device/process approval background with a major, major pharm/med device player (Guidant), their chairman of the BOD also ran a successful med device company acquired by Guidant, they have a listed stock trading at about $40 Euro (about $55 bucks a share)- not a penny stock, have recently raised more cash- as in $10's of millions more, etc. Not exactly the present BHRT "story" as I know it or in my humble opinion? Not really seeing the comparison here?
http://www.finanzen.net/nachricht/Cardio3-BioSciences-Reports-2013-Financial-Results-and-Business-Update-3374339
http://www.c3bs.com/en
http://www.c3bs.com/en/executive-management-team
http://www.c3bs.com/en/board-directors
http://www.c3bs.com/en/share-price
http://www.c3bs.com/en/products-pipeline
So, do not really get or see these "linkages" of news stories about one company that's totally unrelated to BHRT, located on a different continent, etc? It's a news release about a totally different biz, in TOTALLY different financial health, with a totally different mgt team and biz plan, etc. Not sure what the connection is or is supposed to mean? Don't see a strong connection myself, in my opinion.
Agree, wouldn't say it the absolute "worst" financial they ever put out, they had a 10-Q a while back (not that long ago) where the cash, balance sheet entry was actually a dash, - , as in GOOSE EGG.
But, and this is a big one- they have increased their spending, meaning they need more cash now coming in than then- or else something has to give, i.e. you cut something, cut people, cut projects as in R&D spending "trials", etc.
Also, the more they dilute, the more the "funding" environment gets tougher/worse, the harder and harder it gets and the terms get worse, for each financing "deal" inked. The terms on those latest Asher deals, I believe by memory, are about the worse I remember seeing (could be wrong, but I'd say close to the worse terms).
Also, they had/have a "stand by equity agreement" with Greystone that they've been drawing on heavily. I've been reading and re-reading it to try and figure out if it comes to an end? It appears to me there may be a closure date on it and that would be major, if they can't re-negotiate or re-up it as they've been using it for a pretty good chunk of their cash in 2013.
Page F-20: 10-K
NOTE 6 – STANDBY EQUITY DISTRIBUTION AGREEMENT
On November 2, 2011, the Company and Greystone Capital Partners (“Greystone”) entered into a Standby Equity Distribution Agreement (the “Agreement”). Pursuant to the Agreement, Greystone has agreed to provide the Company with up to $1,000,000 of funding for the 24-month period following the date February 10, 2012, the registration statement of the Company’s common stock was declared effective by the SEC (the “Equity Line”).
During this 24-month period, commencing on the date on which the SEC first declared the registration statement effective, the Company may request a draw down under the Equity Line by which the Company would sell shares of its common stock to Greystone, which is obligated to purchase the shares under the Agreement.
For each share of the Company common stock purchased under the Agreement, Greystone will pay eighty percent (80%) of the average of the lowest daily volume weighted average price for five consecutive trading days immediately preceding Advance Notice (the "Valuation Period") commencing the date an Advance Notice (the "Advance Notice") is delivered to Greystone in a manner provided by the Agreement. Subject to certain limitations and floor price reductions, the Company may, at its sole discretion, issue a Put Notice to Greystone and Greystone will then be irrevocably bound to acquire such shares. The registration statement of the Company's common stock pursuant to the Agreement was declared effective on February 10, 2012 and a Post-Effective Amendment was declared effective on May 7, 2013. On December 1, 2012, the parties to the Equity Line agreed that the Purchase Price be adjusted to seventy-five percent (75%) of the lowest daily volume weighted average price of the Common Stock as quoted by Bloomberg, LP, during the five (5) consecutive Trading Days (as such term is defined in the Equity Line) immediately subsequent to the date of the relevant Advance Notice.
During the year ended December 31, 2013, the Company issued an aggregate of 31,052,141 shares of its common stock in exchange for $346,914 draw down on the equity line. During the year ended December 31, 2012, the Company “put” 8,797,859 shares of common stock for a total of $150,000."
See that language about 24 months from Feb 10, 2012? That's the one that caught my eye? That would be Feb 10, 2014 which just passed? So is this equity line type deal GONE, TAPPED OUT, CLOSED? I can't be sure reading it- just don't understand the language enough, not seen this kinda deal before? But it sure seems like it may be closed or ended? And they've used it for a fair amount of cash in 2013. So if it's not there now as of just last month or so, that could also be a major factor. Not sure?
They've also been relying on "delayed interest" payments due to Northstar, and "loans" from insiders, maybe even appears delaying salaries (bonuses were delayed as there appears no cash to pay such), they've had internal loans-delayed payments to insiders it appears, etc. In other words, you can only work so many "shuffling the chairs around on deck" and "pull the rabbit out so many time" and such, IMO and finally you get backed further and further into the proverbial corner and just run out of options? Know what I'm saying? It's the ole using one credit card to pay the other while you got your other item at the pawn shop and got a payday advance and all- it eventually gets harder and harder to get out of the box, IMO.
So, no matter how you slice it, dice it, etc CASH IS TIGHT and CASH IS KING in keeping a biz open and functioning, let alone taking on aggressive projects and grand undertakings like FDA trials and cutting edge research or creating a marketing/sales team to sell all this new stuff worldwide or whatever. They need CASH, need it all the time and made statements alluding to the fact that if ANY key "window" of borrowing, or share selling (lets say Asher says NO next time perhaps- speculating), etc- they have made indications that they, BHRT would be in the serious squeeze. Again, I don't think Sr Mgt puts that stuff in the 10-K, willy-nilly and signs off on it. I mean who would want that stuff in their 10-K when it makes your company look weak, unless they felt that legally and fiduciary wise and audit wise, they HAD TO PUT IT IN THERE to give fair disclosure? I don't think for a second they put those warnings in their lightly or as "boiler plate". They know they need to be on the full-up disclosure and tell it straight. That's my opinion.
Page 25, 10-K:
Item 1A. Risk Factors
The risks and uncertainties described below are not the only ones facing us. Other events that we do not currently anticipate or that we currently deem immaterial also may affect our results of operations and financial condition. If any events described in the risk factors actually occur, our business, operating results, prospects and financial condition could be materially harmed. In connection with the forward looking statements that appear elsewhere in this annual report, you should also carefully review the cautionary statement referred to under “Cautionary Statement Regarding Forward Looking Statements.”
Risks Related to Our Financial Position and Need for Additional Financing
We will need to secure additional financing in 2014 in order to continue to finance our operations. If we are unable to secure additional financing on acceptable terms, or at all, we may be forced to curtail or cease our operations.
As of March 24, 2014, we had cash and cash equivalents of approximately $211,632.80 and a working capital deficit of approximately $13.4 million. As such, our existing cash resources are insufficient to finance even our immediate operations. Accordingly, we will need to secure additional sources of capital to develop our business and product candidates as planned. We are seeking SUBSTANTIAL additional financing through public and/or private financing, which may include equity and/or debt financings, research grants and through other arrangements, including collaborative arrangements. As part of such efforts, we may seek loans from certain of our executive officers, directors and/or current shareholders. We may also seek to satisfy some of our obligations to the guarantors of our loan with Seaside National Bank & Trust, or the Guarantors, through the issuance of various forms of securities or debt on negotiated terms. However, financing and/or alternative arrangements with the Guarantors may not be available when we need it, or may not be available on acceptable terms.
If we are unable to secure additional financing in the NEAR TERM, we may be forced to:
· curtail or abandon our existing business plan;
· reduce our headcount;
· default on our debt obligations;
· file for bankruptcy;
· seek to sell some or all of our assets; and/or
· cease our operations.
If we are forced to take any of these steps, any investment in our common stock may be worthless."
"They must feel pretty confident they can pay off $100,000 worth of notes prior to the conversion in such a short term. " ??
Based on what info or theory? The very reason they did the "notes/convertibles" is that they are very low or almost HAVE NO CASH for day to day needs. Where would the cash to "pay off" materialize from? And if they can pay them off so easily, then WHY even do them in the first place. Makes no sense at all IMHO. None.
Page 25: 10-K
"Risks Related to Our Financial Position and Need for Additional Financing
We will need to secure additional financing in 2014 in order to continue to finance our operations. If we are unable to secure additional financing on acceptable terms, or at all, we may be forced to curtail or cease our operations.
As of March 24, 2014, we had cash and cash equivalents of approximately $211,632.80 and a working capital deficit of approximately $13.4 million. As such, our existing cash resources are INSUFFICIENT to finance EVEN OUR IMMEDIATE operations. Accordingly, we will need to secure additional sources of capital to develop our business and product candidates as planned. We are seeking substantial additional financing through public and/or private financing, which may include equity and/or debt financings, research grants and through other arrangements, including collaborative arrangements. As part of such efforts, we may seek loans from certain of our executive officers, directors and/or current shareholders. We may also seek to satisfy some of our obligations to the guarantors of our loan with Seaside National Bank & Trust, or the Guarantors, through the issuance of various forms of securities or debt on negotiated terms. However, financing and/or alternative arrangements with the Guarantors may not be available when we need it, or may not be available on acceptable terms.
If we are unable to secure additional financing in the near term, we may be forced to:
· curtail or abandon our existing business plan;
· reduce our headcount;
· default on our debt obligations;
· file for bankruptcy;
· seek to sell some or all of our assets; and/or
· cease our operations.
If we are forced to take any of these steps, any investment in our common stock may be worthless."
Does Sr management toss a statement in the 10-K like that for NO REASON, or "lightly" or "frivolously"? They use very specific wording like " even OUR IMMEDIATE NEEDS".
WHY would that statement be there if they can "easily pay off the $100,000", etc? WHY? Why even go to Asher then? It makes no sense IMHO?
Asher "toxic or "death spiral" convertible share based financing used again, as cited on 10-K, page F-41, and it was done recently, as in as recently as Feb of 2014.
Page F-41 of 10-K, Quote:
Subsequent financing
On January 14, 2014, the Company entered into a Securities Purchase Agreement with Asher Enterprises, Inc. (“Asher”), for the sale of an 8% convertible note in the principal amount of $32,500 (the “Note”).
The Note bears interest at the rate of 8% per annum. All interest and principal must be repaid on October 16, 2014. The Note is convertible into common stock, at Asher’s option, at a 45% discount to the average of the three lowest closing bid prices of the common stock during the 10 trading day period prior to conversion. In the event the Company prepays the Note in full, the Company is required to pay off all principal, interest and any other amounts owing multiplied by (i) 140% if prepaid during the period commencing on the closing date through 179 days thereafter. After the expiration of 180 days following the date of the Note, the Company has no right of prepayment.
On February 10, 2014, the Company entered into a Securities Purchase Agreement with Asher Enterprises, Inc. (“Asher”), for the sale of an 8% convertible note in the principal amount of $32,500 (the “Note”).
The Note bears interest at the rate of 8% per annum. All interest and principal must be repaid on November 12, 2014. The Note is convertible into common stock, at Asher’s option, at a 45% discount to the average of the three lowest closing bid prices of the common stock during the 10 trading day period prior to conversion. In the event the Company prepays the Note in full, the Company is required to pay off all principal, interest and any other amounts owing multiplied by (i) 140% if prepaid during the period commencing on the closing date through 179 days thereafter. After the expiration of 180 days following the date of the Note, the Company has no right of prepayment.
On February 19, 2014, the Company entered into a Securities Purchase Agreement with Daniel James Management, Inc., for the sale of an 8% convertible note in the principal amount of $35,000 (the “Note”).
The Note bears interest at the rate of 8% per annum. All interest and principal must be repaid on February 18, 2015. The Note is convertible into common stock, at Asher’s option, at a 47% discount to the lowest daily closing bid price of the common stock during the 10 trading day period prior to conversion. In the event the Company prepays the Note in full, the Company is required to pay off all principal at 150%, interest and any other amounts.
Asher will go SHORT at some point in the future in my opinion. Anyone who got the "convertible" shares Jan 14, Feb 10 and Feb 19 of 2014 (they are "floorless" with steep discounts and "conversion" provision based on a formula of stock price for X trading days, blah, blah, blah)
When you see that "toxic" type financing- it usually means they are making money on the "up" portion as in the recent run-up, and then, at some point, will most likely go brutally short to make even more money.
Here is from the SEC, they explain these "convertibles" and what can happen.
https://www.sec.gov/answers/convertibles.htm
By contrast, in less conventional convertible security financings, the conversion ratio may be based on fluctuating market prices to determine the number of shares of common stock to be issued on conversion. A market price based conversion formula protects the holders of the convertibles against price declines, while subjecting both the company and the holders of its common stock to certain risks. Because a market price based conversion formula can lead to dramatic stock price reductions and corresponding negative effects on both the company and its shareholders, convertible security financings with market price based conversion ratios have colloquially been called "floorless", "toxic," "death spiral," and "ratchet" convertibles.
Both investors and companies should understand that market price based convertible security deals can affect the company and possibly lower the value of its securities. Here's how these deals tend to work and the risks they pose:
* The company issues convertible securities that allow the holders to convert their securities to common stock at a discount to the market price at the time of conversion. That means that the lower the stock price, the more shares the company must issue on conversion.
* The more shares the company issues on conversion, the greater the dilution to the company's shareholders will be. The company will have more shares outstanding after the conversion, revenues per share will be lower, and individual investors will own proportionally less of the company. While dilution can occur with either fixed or market price based conversion formulas, the risk of potential adverse effects increases with a market price based conversion formula.
* The greater the dilution, the greater the potential that the stock price per share will fall. The more the stock price falls, the greater the number of shares the company may have to issue in future conversions and the harder it might be for the company to obtain other financing.
Here is another quote explaining this type of "financing"- this was put together by someone right here on I-hub and is a good explanation of "death spiral" financing and "convertibles":
http://investorshub.advfn.com/~-ASHER-~-25451/
I would not be surprised, in my opinion, to see at some point- near future, that Asher turns and shorts this hard, like in real hard as we've seen in the past few yrs. Where they can put down pressure that rapidly brought the price down to the 1 penny range and in one spike (don't know if it was them for certain?) to .0063. But in my opinion, they are motivated to go short in the future from everything known about how Asher operates and "does what they do" when they provide this type of convertible share financing with those discounts and "share price conversion" formulas you see listed on page F-41 of 10-K. That's my opinion, I think it can tank hard at some point- with dudes who got way more power to swing the price than any retail Joe Shmoe.
"The last time I emailed Mike about someone mentioning the mirror trials being postponed on this message board, he said that was material information and it will be discussed in the upcoming 10k so we shall see."
That was the quote of a post a week or so ago. The MIRROR trial in the 10-K barely got a mention. A few lines of boiler plate, same as in last 10-Q. So did he "discuss" it in this 10-K? I guess a few lines could be called "discussed" if you split hairs? But I don't think that's what was "implied" - as in, an update would be given? Just my opinion from reading what supposedly transpired in that email quoted above?
Now, we're being told today that MIRROR "might" be addressed via Comella in a "blog or something" (based again on a CEO private EMAIL?), we'll see?
So this "Mike has been emailed" and then his responses are to be taken over the info in the 10-K? I'm not clear here and it's very confusing IMO?
"The 10K is 2013 this is 2014"
They included 2014 "updates" regarding other matters in the 10-K. Look at the financing updates that go right on through late Feb of 2014.
I believe there are other 2014 matters "updated" too- will read again, and see if I can find them.
So it appears they can provide update info right up until the day before the 10-K was filed, which is up to March 24th or so. So why wouldn't it have been included? They made a point to show their cash position "updated" - so why not MIRROR?
You tell me/us please? Would like to know- why do it in a "blog" or whatever. That's my opinion.
The "Mike was emailed" again response, and he asked "was it online"? Really? The CEO worries about/cares what is said "online" when they just put the 10-K out and Mirror didn't even get more than a few lines of mention?
So, he states that he will send Comella out to "update" in a blog or whatever? How can she update via a blog, but the same info was not in the 10-K? What sense would that make?
The 10-K is the LEGAL means by which a public traded company communicates. NOT by private emails to someone on a chat board and then via a "blog" to "add" info that was not in the 10-K just released. That's my opinion(s).
Seems like no matter what happens, no matter what their legal, SEC filings say, someone always claims it is/has been, or will be answered in some "private" email or later in a "blog" or whatever. Never seen/heard anything like it in following PUBLIC traded companies. Again, to each his/her own. Me, not buying it. 10-K for me is it. That's the document that matters, IMO only. Good luck with blogs, Pr's and emails. I guess we shall see.
As to "projecting" that certain things will "bare fruit" and all the rest- that's just that, "projecting". The numbers on the 10-K were about $5K a month in revenue. That's it at this point. "Projecting" is not easy to do, and the company has put out no formal "projections" as to revenue estimates per any of these "deals/projects" that I am aware of. Traditionally, it some companies would put out sales "projections" as they have sales managers, sales teams on the ground, and are making sales- and thus "project and make estimates" and set targets to hit for each qtr, mid yr, end of yr, etc. I am not aware of any "formal" or any sales projections at all being released by BHRT. I don't know how a person, via reading a few lines in a 10-K can "project" that sales will occur and "bare fruit" or how they'd even do that?
Further, Mirror was the key event being discussed for months. To not have expected "any enrollment update" when it's been since July, when they said ONE person "enrolled" seems odd? Why would everyone not expect an update and results when this was (past tense) essentially touted as the flagship product/project for the entire purpose of the company (Myocell and FDA approval?). Again, IMHO, not see it the same way, not at all. Good luck.
"In the last PR about Mirror they state that Mirror is "fully funded by BioHeart"... Which should mean that Mirror is funded."??
The 10-K states ALL "finances" and CASH sources available as of the date it was issued- there is no "secret" pile of money sitting somewhere or secret "funding" box/drawer that will be opened to "fund Mirror"?
Why does that PR/blog or whatever statement above keep getting repeated Ad nauseam? The 10-K IS IT, it's the binding, audited, legal "snap-shot" of where things are at. Again, there's no "money/funding box" hidden away. The 10-K shows the cash position as pretty desperate- with several warnings throughout it and continual "financing" deals being done right up until very recently, selling shares to Asher for instance for a mere $32.5K in cash. Would they be doing those convertible shares deals for that pittance amount of cash, cause there is some "lock box or stash" of big cash "funding" hiding away somewhere?
Read the 10-K and try and understand it. It's all that's needed to know IMO. It's the end all document, what is said in past PR or "blog" or whatever, don't count for much IMHO. The 10-K is there and is audited and is signed by the pertinent, key people for a reason.
Marvel and Regen appear to have been dead in the water and gone no where, as you stated, for several years now. Unfunded, unmoved, or whatever. The boiler plate language on them just gets repeated in every 10-Q/10-K each period. And yes, they sit on the .gov site as registered, but nothing appears to have progressed or changed on them.
Mirror got a "barely mention" in this 10-K and in the last 10-Q so where has it gone? Explanations keep getting posted that more info will come, that no info is "normal" given that XYZ was said way back when. Me, not buying it. Mirror was touted, blasted in PR as their "big thing and big push", not "medical tourism" or whatever else. If there was enrollment or other updates, they do not hold them back- in fact if it was "registered", one key thing that would need to be happening is timely updates on enrollment numbers, progress, etc.
Look at the R%D budget spending compared to overhead/salaries and so forth. I don't see how you run multiple trials plus all this other "stuff" all over the place on what, about $600K or so total spent in a yr, but almost 4X that was spent on salaries and rent and costs for a 4 or 5 person company?
None of it makes any sense to me. Broad claims have been posted that they would no longer be diluting/share selling because of "major revenues" now, etc. Didn't even come close. Sales were about $5K a month, which is nothing in the ballpark to fund trials or more- it doesn't even pay their rented facility rent for a yr. Posts claim they will have "big sales" and have product(s) plural to sell- as if this is their business now? I'm not seeing it, IMO.
What happened to being a "Heart" company pursuing high grade, FDA type trial(s) heading to an end game of approval? IMO from everything I've read now- I don't know? Debates are being posted here now splitting hairs on the dilution occurring over 5 months, or 5 months and a few weeks - as if it makes any difference in the slightest. The numbers were posted and clear- that the shares have doubled in less than the past one year and they are still diluting in the 35-40 million shares a qtr "range" right up until this 10-K was issued- so what difference does a week or 3 weeks make in the dilution calculation. 150 million a yr rate is probably on the low side as it was over 200 million last yr- but the hair splitters want to debate that, rather than WHERE DID MIRROR GO and other real important things- like all the posts about "income will replace dilution" being not even remotely true at this point- and no indication is there that, that will come true anytime soon IMO only.
It comes down to a blind love affair versus reality, I guess for some. To each his/her own. The report says what it says and there is no debate IMHO that they are in desperate straights for cash at any given time, and the report is the proof- as their are multiple statements and warning in their own words saying just that, and the "financing" terms (convertibles, share discount, early penalty pay off clause) are only getting worse at best, not better by any stretch. They did Asher and other "deals" right up until late in Feb. for around $30K or $35K of cash ea, meaning they need that much trickling in, just to keep things going. Right where that is stated, is their own warning that cash on hand is not even sufficient to meet their current needs/obligations and they must find sources continually (my paraphrase- I can give exact page number and quote 10-K for the debaters/critics). It is what it is and says what it says.
My opinion, they don't have the money to fund major trial(s) at this point- I just don't see how from the numbers put up in that 10-K, and that's just my opinion knowing what is typically said in industry and other credible publications about what a typical, major, phase II or III trial takes/costs to drive to completion. That's my take and opinion. See it any way you want for anyone else.
Sales were insignificant- not even close to "stopping dilution" as was posted many times previously.
Page 54, 10-K:
We recognized revenues of $96,085 in 2013 compared to revenues of $61,109 in 2012
Cost of sales consists of the costs associated with the production of MyoCath.
Cost of sales was $30,831 in the twelve-month period ended December 31, 2013 compared to $1,070 in the twelve-months ended December 31, 2012.
So they netted, or had a gross profit on the 2013 sales of $96,085-$30,831 = $65,254.00 / 12 = about $5K a month. That's a pimple on their cash use/burn rate.
Net cash used in operating activities was $1,913,326 in 2013 . (I'm not even sure if cash for interest on debt would need to be added into that number, pretty sure it would- their report is confusing to me, but lets just use that number above- since costs/cash use appear to be going up if anything from their statement of hiring a few people etc)
$1,913,326 / 12 = about $160K a month, cash needed to keep operations going "as-is", keep the lights on, pay themselves, whatever else they are doing.
So, $5K in sales / $160K cash used in operations = 3% of cash needs. Not hardly "stopping dilution" by any stretch. And again, I believe, need to read more- that they actually need more than that coming in to service debt interest and other cash going out. But $160K would appear to be a bare, bare minimum.
Also, as it appears in last 10-Q's, my opinion is the SG&A costs are mega high to the R&D budget and the size of the company- just my 2 cent opinion. But it seems most of the money goes to pay themselves or whatever "stuff" falls under SG&A, salaries usually being the biggest in that category (their rent is like $65K a yr, they say they carry no product liability insurance in the doc, etc- so what else would it be spent on?)
PAGE 61:
Research and Development
Research and development expenses were $626,983 in 2013, an increase of $225,042 from research and development expenses of $401,941 in 2012. The increase was primarily attributable to an increase in the amount of available funds.
The timing and amount of our planned research and development expenditures is dependent on our ability to obtain additional financing.
Marketing, General and Administrative
Marketing, general and administrative expenses were $2,267,831 in 2013, an increase of $89,479 from marketing, general and administrative expenses of $2,178,352 in 2012. The increase in marketing, general and administrative expenses is attributable, in part, to an increase in legal fees, salaries and insurance expenses.
Interest Expense
Interest expense was $1,437,883 in 2013 compared to interest expense of $1,619,653 in 2012. Non cash interest comprised of amortization of debt discounts and warrants issued in connection with debt totaled $597,339 in 2013 as compared to $657,081 in 2012. In addition, in 2012, we issued warrants in connection with a forbearance agreement with Northstar at a fair value of $430,213; in 2013 we issued preferred stock in in connection with a forbearance agreement with Northstar at a fair value of $274,050.
So about $600K was spent on R&D (trials, etc) and their Marketing (they have none really- they don't sell anything for the most part) GENERAL and ADMINISTRATIVE- the big ones in my opinion (salaries) was $2.2 million or almost 4X the R&D budget for a 4 or 5 person operation? Doesn't make sense to me, but that's my opinion?
It looks like Tomas and Comella got big salary (like BIG percentage wise) boosts or bonuses also on the compensation page (someone posted a while back- Tomas is RICH RICH (exact word the post used) and that he takes no pay)- but that's not what this document is saying:
PAGE 71:
Summary Compensation Table
The following table sets forth, for the fiscal years ended December 31, 2012 and 2011, the aggregate compensation awarded to, earned by or paid to our Chief Executive Officer and our two most highly compensated officers (other than the Chief Executive Officer), who were serving as executive officers as of December 31, 2013, or the Named Executive Officers.
Tomas $391K in salary + $375K bonus
Comella $159K + $125K bonus
Plus a bunch of options
(1)
On August 1, 2013, Mr. Tomas and Ms. Comella received $375,000 and $125,000, respectively, promissory notes for bonuses awarded. The promissory notes bear 5% interest per annum, unsecured and are due on demand.
(2)
On August 1, 2013, Mr. Tomas and Ms. Comella were granted 10,000,000 and 5,000,000, respectively, options to purchase the Company’s common stock at $0.01576 per share for ten years, vesting annually over four years.
(3)
On September 1, 2013, Mr. Tomas, as a member of the Company’s Board of Directors, was granted 400,000 options to purchase the Company’s common stock at $0.01654 for ten years, vesting immediately.
So, just those base salaries alone, for TWO people would consume $391K + $159K = $550K / 12 = $45K a month of their cash needs/use of $160K. That's 25% of cash used- going to pay TWO PEOPLE.
It's almost equal to their R&D budget (R&D for yr was about $626K), WOW. TWO people in a 4 or 5 person company (yahoo lists 4 full time employees), consuming-getting paid close to the entire R&D budget of what's deemed a "R&D development stage company"? And that's not including their bonuses listed- which would have them receiving more than the entire R&D budget for just 2 people? Wow? Tomas with base + bonus + options for 2013 has a compensation listed of $936,804.00 for a 4 or 5 person company with no sales, very little cash, lots of dilution and a micro penny stock price? Wow again IMHO.
I've worked for very profitable companies with about $200 million in sales, 1000 plus employees- and that's about what the CEO or maybe the most Sr. VP was pulling down, probably even less base salary for VP's- only making that much if they sold options they'd built up over yrs and yrs of working a very successful, highly profitable, NASDAQ listed company with a market cap of $400 million or so.
My 2 cents again, seems out of whack cost structure to me- but hey, that's just me. That's my take on some of the basic numbers- just my math, my number crunching and opinion only- could be wrong, it's late, I'm tired from reading the 10-K. But wow, it looks lopsided IMHO.
Corrected. So, on the last 10-Q it is listed as of Sept._____ and never filled in that blank. So we'll say it's for 4 to 5 months for 73 million shares of dilution (my opinion on my read of the documents).
So lets call it about 40 million a qtr. which will be over 150 million shares a year at this rate. Is that good? I'd say the common shareholders, in my opinion are getting heavily diluted no matter how you slice it.
Today, March 25 the share count now stands at about 420 MILLION shares.
It was only April of last yr that they were at 200 million and blew through their allowed number of shares per their charter, and just upped it to like 950 million or something allowed shares outstanding. It's easy to see now why they chose such an enormous number.
As of April 30, 2013, there were 200,623,903 outstanding shares of the registrant’s common stock, par value $0.001 per share.
So, in less than one yr, April 30 2013, to March 25th 2014, the common holder has seen the shares more than double, diluting them down by half (someone owning 10 million shares would have owned 5% of the company less than a yr ago 10 mil/200 mil, and now they own 2.5%, 10 mil/400 mil shares). The only thing that seems consistent is the constant selling/dumping of shares for every reason under the sun- I read through that 10-K and they hand out shares like water- for financing, for paying people, for debt payments- I can't even remember all the places they said they handed out millions of shares for XYZ or whatever.
So, yeah- the 73 million is for 5 months or whatever. If that's a good thing- well, I don't see it that way IMO. It's massive dilution IMO no matter how you slice it.
Several posts in the previous week made the claim the dilution will/would have stopped. Not even close, not even remotely close.
Cash update page 25, interesting: Looks like they put in an "update line" as of day before release- on their latest cash/debt position. They list $211K cash and equivalents (how much is actual "cash" versus "equivalents" - not enough info). So that Asher activity of $100K up through late Feb added some cash for sure, and maybe some of the recent income was booked- I see "some" income on balance sheet from catheter sales, services, etc. So cash beefed up a bit it looks like in the past 3 months, but that's typical of how they run usually- they sell shares, do "financing", get cash on the books good for a month or two of funding operations/burn rate, then wash, rinse, repeat. $211K per my guesstimate from the last burn-rate calc, is really only a month, maybe 1.5 months of cash? But it's better than the $40K or whatever on the balance sheet. Guess they did a "snap shot", last minute before the 10-K release (wonder if it's audited- I'd doubt it)- probably their best estimate of cash-on-hand and debt as of right now, all IMO.
Page: 25
"Risks Related to Our Financial Position and Need for Additional Financing
We will need to secure additional financing in 2014 in order to continue to finance our operations. If we are unable to secure additional financing on acceptable terms, or at all, we may be forced to curtail or cease our operations.
As of March 24, 2014, we had cash and cash equivalents of approximately $211,632.80 and a working capital deficit of approximately $13.4 million. As such, our existing cash resources are insufficient to finance even our immediate operations. Accordingly, we will need to secure additional sources of capital to develop our business and product candidates as planned. We are seeking substantial additional financing through public and/or private financing, which may include equity and/or debt financings, research grants and through other arrangements, including collaborative arrangements. As part of such efforts, we may seek loans from certain of our executive officers, directors and/or current shareholders. We may also seek to satisfy some of our obligations to the guarantors of our loan with Seaside National Bank & Trust, or the Guarantors, through the issuance of various forms of securities or debt on negotiated terms. However, financing and/or alternative arrangements with the Guarantors may not be available when we need it, or may not be available on acceptable terms.
If we are unable to secure additional financing in the near term, we may be forced to:
· curtail or abandon our existing business plan;
· reduce our headcount;
· default on our debt obligations;
· file for bankruptcy;
· seek to sell some or all of our assets; and/or
· cease our operations.
If we are forced to take any of these steps, any investment in our common stock may be worthless."
Gs, respectfully, I never discuss what I own, how much, etc. That's my personal business.
I will say this- my biggest (what's the word?) concern, at this point is that Mirror appears to have gone M.I.A.
From that, I open the question(s): What is BHRT really doing, trying to be, what is their end game now, or anymore? It's all getting muddled to me?
Are they really a legit, FDA trial pursuing, drive a product to the FDA big finish line, get approval and gain the kind of market cap that has been batted around? Or, have they "morphed" into some kind of "medical tourism" gig, hock/sell/pitch stem cells for every ailment known to man, all over the 2nd and 3rd world for whatever cash it brings in kinda deal? I mean, they are called BioHEART- but they seem to be losing their direction to me, my opinion only.
Do they merely exist anymore to sell/dump shares (73 MILLION this qtr alone) to keep the gig going as long as they can milk it- paying themselves salaries, paying back the Northstar insiders as much as possible, etc? I'm really starting to wonder where this is all supposed to be heading?
Given the financial realities- which no one can skirt around or deny are in pretty dire straights, and given that Mirror, again, just got a "barely mention" in your most important document you put out each yr- I don't "get it" anymore who, what, where they are, are going or trying to be? Really not seeing it? ED, eye stuff, animal Stemlogix, Middle East deal (notice- no mention typically of these "deals" when it comes 10-K time), Honduras, and on and on and on? What's the end game. What happened to the big goal? HOW can you possibly manage 10 or more major projects with 4 or 5 full time people- and also run a phase III trial(s)? How? And how to you do a phase III when your cash on hand at any given moment varies between about ZERO (really zero) and now about $40K or so? How? It's mathematically, biz wise impossible based on what is well known about what a legit, phase III and FDA submission takes to pull off and get to the goal line.
So, yeah- I see huge red flags in this 10-K at just a cursory read. I saw problems, big ones in the past couple of 10-Q's, but everyone had the "they have a new plan- it's turning around" kinda thing going on. Now, after first glance at this document- I'd say that's all up in the air in my, and my opinion only. This 10-K to me, nothing but same old, same old and some parts looking worse, more dire than ever. Not good in my opinion. Is the stock still a trade maybe- sure. Would I think to go real long now and feel good sleeping over weekends and all- I don't know? I think most now are "trading" this stock and that's a whole different ball game from being an "investor" in the company for the long haul. That's my 2 cents- I still need to spend at least an hour or more and plan to read every page, word for word on that 10-K.
Good luck to ya- if you believe, then hang tight- I just hope you don't have the life savings riding on it, or money you can't afford to lose. Nothing wrong with locking in some profits you know- it doesn't make you guilty or not a "believer" as I think someone else just posted- a very good way to put it.
Truthfully? YES, you could get those same discounts if you were willing to barf up, cold, hard CASH and give it to BHRT.
You understand why those guy's (Asher and such) can demand those terms, correct? It's because BHRT is deemed a very high risk entity to loan too (as in default someday is a real possibility). BHRT needs cash, Asher and similar are what's known as "lenders of LAST RESORT". They're the end of the road when you got no place left to go.
BHRT has no cash flow essentially, no assets per say, a lot of debt, etc. So Asher is willing to put up cash to lend- but they want, like all lenders, a pretty good shot at getting repaid, AND for the high risk, they want a high return. Not 5% like they can get doing foo-foo lending on autos or even pawn shop stuff. Dudes like Asher wanna make like 25% or more return on each deal- they're about a step away from some guy named "Gueedo" who works for the "mob" in some seedy neighborhood of Jersey. Everything short of the breaking the knee caps is about it IMO. The terms they demand are as brutal as they get- and they're pros, real, real good at what they do- as in making money going both ways (upside on stock and then brutal shorting to the downside on those convertible shares).
So yes, you could probably get some discounted shares if you were a registered, institutional broker/dealer and could cut checks for $30K chunks at a time. Notice- there's some new firm listed, "Danial James Mgt". I haven't even looked them up yet to see what their name and reputation is on "The Street". I'm sure they're probably well known too as a "lender of last resort" to micro-cap companies in the squeeze.
The 10-K add-ons at the end include "financing" (toxic by the way) that is darn near right up until the present. Page F-41 covers right up until Feb 19th of this yr. Look a the amounts- if they didn't put that cash on the books ASAP, that $40K or so they are showing now would have been ZERO. GOOSE EGG. 2014 (Jan $32,500 + Feb 10th $32,500 + Feb 19th $35K (Daniel James: a new one, will have to look up who they are) = 32.5 + 32.5 + 35K = $100K dollars in early 2014 already (up to almost exactly one month ago). They are in DIRE NEED OF CASH obviously- dire IMO. You don't sign terms like those below for a lousy $100K unless you're paying bills day to day, month to month. No way.
Subsequent financing
On January 14, 2014, the Company entered into a Securities Purchase Agreement with Asher Enterprises, Inc. (“Asher”), for the sale of an 8% convertible note in the principal amount of $32,500 (the “Note”).
The Note bears interest at the rate of 8% per annum. All interest and principal must be repaid on October 16, 2014. The Note is convertible into common stock, at Asher’s option, at a 45% discount to the average of the three lowest closing bid prices of the common stock during the 10 trading day period prior to conversion. In the event the Company prepays the Note in full, the Company is required to pay off all principal, interest and any other amounts owing multiplied by (i) 140% if prepaid during the period commencing on the closing date through 179 days thereafter. After the expiration of 180 days following the date of the Note, the Company has no right of prepayment.
On February 10, 2014, the Company entered into a Securities Purchase Agreement with Asher Enterprises, Inc. (“Asher”), for the sale of an 8% convertible note in the principal amount of $32,500 (the “Note”).
The Note bears interest at the rate of 8% per annum. All interest and principal must be repaid on November 12, 2014. The Note is convertible into common stock, at Asher’s option, at a 45% discount to the average of the three lowest closing bid prices of the common stock during the 10 trading day period prior to conversion. In the event the Company prepays the Note in full, the Company is required to pay off all principal, interest and any other amounts owing multiplied by (i) 140% if prepaid during the period commencing on the closing date through 179 days thereafter. After the expiration of 180 days following the date of the Note, the Company has no right of prepayment.
On February 19, 2014, the Company entered into a Securities Purchase Agreement with Daniel James Management, Inc., for the sale of an 8% convertible note in the principal amount of $35,000 (the “Note”).
The Note bears interest at the rate of 8% per annum. All interest and principal must be repaid on February 18, 2015. The Note is convertible into common stock, at Asher’s option, at a 47% discount to the lowest daily closing bid price of the common stock during the 10 trading day period prior to conversion. In the event the Company prepays the Note in full, the Company is required to pay off all principal at 150%, interest and any other amounts.
I don't see any "debt being paid off"? Where? Again, I haven't had time to do this a thorough read- but here is a "quick" analysis using just my on-screen calculator and a couple of key word searches. I see no indication of "major debt" being paid down- it's listed as almost exactly the same from last period:
Debt is essentially the same and cash only is up by about $40K at this point- noise level money IMO and that’s after diluting 73 MILLION shares in a single qtr. Mirror appears to have gone nowhere- that’s my 2 cent general summary read at this point- my opinions only based on what I alone am reading. (debt was $13.4 million in last 10-Q and is reported as $13,362,480 below from this 10-K)
10-K just issued:
At December 31, 2013, we had cash and cash equivalents totaling $46,227; our working capital deficit as of such date was $13,362,480. Our independent registered public accounting firm has issued its report dated March 24, 2014 in connection with the audit of our financial statements as of December 31, 2013 that included an explanatory paragraph describing the existence of conditions that raise substantial doubt about our ability to continue as a going concern.
The number of shares outstanding of the registrant’s Common Stock, $0.001 par value, as of March 24, 2014 was 420,920,157.
Previous 10-Q, from last qrt:
At September 30, 2013, we had cash and cash equivalents totaling $6,684. However our working capital deficit as of such date was approximately $13.4 million. Our independent registered public accounting firm has issued its report dated March 28, 2013 in connection with the audit of our financial statements as of December 31, 2012 that included an explanatory paragraph describing the existence of conditions that raise substantial doubt about our ability to continue as a going concern and Note 2 of our unaudited financial statement for the quarter ended September 30, 2013 addresses the issue of our ability to continue as a going concern
As of November ____, 2013, there were 347,175,310 outstanding shares of the Registrant’s common stock, par value $0.001 per share.
So how much total dilution occurred in a one qrt period? My math is below- that’s my calc, someone else may see it differently?
(420,920,157 – 347,175,310 = 73,744,847 shares diluted). 73,744,847/ 347,175,310 = .21 x 100 = 21% dilution in a single quarter- and IMO, I don’t have a clue what major accomplishment there is to show for it? They seem real good at selling shares and paying themselves and paying back interest and stuff on loans like Northstar- that’s the way I see it. As for the common shareholder and what they get, will get? Who the heck knows. THE BIG ONE, MIRROR- and it gets a “barely” passing mention again. TROUBLE ALERT for me on that one. Mirror used to be, was the “end game” the way I saw it. Now I don’t see it at all. It for all intents and purposes to me, appears stalled out and going nowhere, or they would have put info out about it.
So, are they an FDA product/approval company running “trials” , driving for Myocell their flagship to get across the FDA finish line, or have they morphed into some shmattering of a “medical tourism”, sell anything and everything “stem cells” all over the 2nd and 3rd world company or whatever? That’s the questions I have- and only are my opinions and my questions and mine alone.
Counter question to "the question"?
"Why did Mike tell us "institutional investors" were investing if this was so bad financially?"??
Any PROOF any "institutional investors" have put up dime one? Let me clarify the way I "parse" a lot of these PR/blog, very carefully worded (MY OPINION ONLY) statements- as in the one you quoted above.
Technically, ASHER is an "institutional investor". See how easy that is? That's the 100% truth. They are a "investment house", they are a licensed trader/broker and have "institutional money lending capabilities" and are a "professional investment firm" who gives cash for equity stakes under BRUTAL terms. But are they "institutional investors"- heck yeah, by every definition I'm familiar with.
So is the CEO statement "true"? Yes. Is it what many who follow the stock were "thinking" or perhaps "hoping" for when they heard "institutional" investors? I don't think so.
See? See how a "carefully", as in very carefully worded statement can "work"?
Death spiral, toxic financing appears to be continuing- right on into 2014, right up until just recently. I'm just doing basic searches to pick out highlight, key issues I look for in every report.
And man- the terms on these deals are BRUTAL IMHO, just for a pittance of cash. BRUTAL. Look at the share discount they get, the interest rate and then the early pay-off penalty of like 150% of face value. WOW. BRUTAL terms- worse than in the past. 45% discount to market, 8% interest and now a payoff penalty (don't remember pay-off penalties in the past, maybe something new, more brutal from old Asher and the boys?). Wow, all for $30K lousy bucks or so at a time. Man- that is like worse than loan shark money terms IMO.
Just did a search on "Asher" and got to the financing area of the report: From page F-41
Subsequent financing
On January 14, 2014, the Company entered into a Securities Purchase Agreement with Asher Enterprises, Inc. (“Asher”), for the sale of an 8% convertible note in the principal amount of $32,500 (the “Note”).
The Note bears interest at the rate of 8% per annum. All interest and principal must be repaid on October 16, 2014. The Note is convertible into common stock, at Asher’s option, at a 45% discount to the average of the three lowest closing bid prices of the common stock during the 10 trading day period prior to conversion. In the event the Company prepays the Note in full, the Company is required to pay off all principal, interest and any other amounts owing multiplied by (i) 140% if prepaid during the period commencing on the closing date through 179 days thereafter. After the expiration of 180 days following the date of the Note, the Company has no right of prepayment.
On February 10, 2014, the Company entered into a Securities Purchase Agreement with Asher Enterprises, Inc. (“Asher”), for the sale of an 8% convertible note in the principal amount of $32,500 (the “Note”).
The Note bears interest at the rate of 8% per annum. All interest and principal must be repaid on November 12, 2014. The Note is convertible into common stock, at Asher’s option, at a 45% discount to the average of the three lowest closing bid prices of the common stock during the 10 trading day period prior to conversion. In the event the Company prepays the Note in full, the Company is required to pay off all principal, interest and any other amounts owing multiplied by (i) 140% if prepaid during the period commencing on the closing date through 179 days thereafter. After the expiration of 180 days following the date of the Note, the Company has no right of prepayment.
On February 19, 2014, the Company entered into a Securities Purchase Agreement with Daniel James Management, Inc., for the sale of an 8% convertible note in the principal amount of $35,000 (the “Note”).
The Note bears interest at the rate of 8% per annum. All interest and principal must be repaid on February 18, 2015. The Note is convertible into common stock, at Asher’s option, at a 47% discount to the lowest daily closing bid price of the common stock during the 10 trading day period prior to conversion. In the event the Company prepays the Note in full, the Company is required to pay off all principal at 150%, interest and any other amounts.
"going concern" warning INTENSIFIED- this is a new one I don't think I've ever seen or read in their past reports? They've added an "emphasis" (my words, definition) to their going concern issues. Quoting, page 26:
"Current Adverse Economic Conditions have had a negative impact on our ability to obtain additional financing. Our inability to obtain additional financing would have a significant adverse effect on our operations.
In early 2008, as the United States economy began to weaken and there were increased doubts about the ability of borrowers to pay debts. Housing values began to fall and marginal loans were first to default, triggering the sub-prime lending crisis. Financial institutions responded by tightening their lending policies with respect to counterparties determined to have sub-prime mortgage risk. This tightening of institutional lending policies led to the failure of major financial institutions late in the third quarter of 2008. Continued failures, losses, and write-downs at major financial institutions through 2013 intensified concerns about credit and liquidity risks and have resulted in a sharp reduction in overall market liquidity. The global credit crisis threatens the stability of the global economy and has adversely impacted consumer confidence and spending. We believe this global credit crisis has also had a negative impact ON OUR ABILITY TO OBTAIN ADDITIONAL FINANCING. As discussed above, our inability to obtain additional financing would have a significant adverse effect on our operations, results and financial condition."
THAT is "interesting" to say the least. I don't believe I've ever seen them add that additional verbiage before about "tightening" of credit or more "difficulty" in continuing to get financing? And now you wonder perhaps why insiders cashed out debt for equity shares in swaps? Interesting IMHO. Very interesting.
This is going to take hours to read cover to cover and dissect anything new/unusual.
If it ain't in the 10-K/10-Q, my opinion is it doesn't mean a thing. The 10-K is the LEGAL DISCLOSURE and is fiduciary and binding. Someone can blog, PR till the cows come home- which is par for this group IMHO and then everything "mysteriously" is never spoke of, or heard about again, especially in the 10-K or similar. I've searched for stuff announced in past PR's in so many 10-Q's, and never found a word or mention of it again. That's been my personal experience and are my opinions only. The fact you didn't find any of these far, vast reaching "deals" in the 10-K does not surprise me one bit or even raise my eyebrow anymore. I'd would have been surprised if you did find any of it in there- that's my 2 cent take and past experiences.
MASSIVE DILUTION- and it was said there would be "none to little" in a previous post.
The number of shares outstanding of the registrant’s Common Stock, $0.001 par value, as of March 24, 2014 was 420,920,157.
From the last 10-Q to today was about 347 MILLION shares to now 420 MILLION which I stated near to the mark in previous posts. Spot on correct to what I estimate from the trend.
Cash and cash equivalents on balance sheet: $46,227.00 total dollars. Yep, over 60 MILLION shares dumped, and all that's left is $46K cash on the books.
"We have also initiated the MIRROR trial, which is a Phase III, double-blind placebo controlled study for centers outside the US. The SEISMIC, MYOHEART,MARVEL and MIRROR Trials have been designed to test the safety and efficacy of MyoCell in treating patients with severe, chronic damage to the heart. Upon regulatory approval of MyoCell, we intend to generate revenue in the United States from the sale of MyoCell cell-culturing services for treatment of patients by qualified physicians."
THAT IS IT- when I did a search on "Mirror"- pretty much a GOOSE EGG NOTHING comes up. WOW !! I'll verify with a cover to cover read- but the search feature usually doesn't miss much? Wow, is all I can say.
I'll read the rest of the report in detail- but it's par for the course so far IMO. A typical BHRT 10-Q/10-K. Massive dilution, almost no cash left, and little to show for it. I'm going to look for every "deal" announced and other key info. Will post later after I get time to read every line.
I'll link to the post that said "no dilution".
Totally agree largely on FDA and especially on something like ADVIL- more people die from "bleed-out" due to NSAIDS than died in Afghanistan in a yr- but they hand it out like candy.
Regarding publishing in journals- gotta say the jury (IMO) is still out on that- from reading so far.
http://clinicaltrials.gov/ct2/manage-recs/resources#InternationalCommittee
International Committee of Medical Journal Editors (ICMJE)
Clinical Trial Registration. Part of the ICMJE Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals (" ICMJE Recommendations "), which is followed by more than 1,000 journals. The ICMJE Recommendations encourage journal editors to require that ALL clinical trials be entered in a public registry before the start of participant enrollment, as a condition of consideration for publication.
WHO (ICMJE) - ClinicalTrials.gov Cross Reference (PDF). Table mapping the WHO Trial Registration Data Set, as required by the ICMJE registration policy, to the corresponding data elements in ClinicalTrials.gov.
ICMJE Frequently Asked Questions About Trial Registration
Journals Following the ICMJE Recommendations. A list of journals who have contacted ICMJE to request listing as a journal that follows the ICMJE's Recommendations.
http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html
(seem REAL CLEAR here as these are the editors- the gate keepers if you will, of every major journal out there)
"Briefly, the ICMJE requires, and recommends that all medical journal editors require, registration of clinical trials in a public trials registry at or before the time of first patient enrollment as a condition of consideration for publication. Editors requesting inclusion of their journal on the ICMJE website list of publications that follow ICMJE guidance should recognize that the listing implies enforcement by the journal of ICMJE’s TRIAL REGISTRATION policy."
That's just two references saying that- I found several more written by several other sources saying the exact same thing.
On the humorous side a bit- when I was googling, this site with the photo came up.
Look at that stack of "submissions" (back in the 60's, I'm sure it's worse today)- imagine wading through that stuff all day and trying to remain sane and awake w/o using copious caffeine, lol !
Wow.
http://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/SummaryofNDAApprovalsReceipts1938tothepresent/default.htm
A picture is worth a 1000 words, or lines of scientific "study" boring reading. Holy smokes- reading those stacks would be mind blowing, but interesting at the same time depending on what the new drug/process is and what it was attempting to treat.
Interesting how the NDA numbers were so high in the past- then sharply dropped off- and now have been more or less constant/flatlined it seems? Bet the cost created by the FDA is one of the main, driving factors? Is the FDA really our friend and helper?
I can easily see an English teach/prof migrating to regulatory- it makes sense. Lots of detailed writing and good communication skills, attention to minutia and minute details as laid out in very specific rule books (like trying to write a paper following the APA or other formats- I went practically insane doing it). As you stated- it's like the FDA is the boss, runs the show- whether you like it or not, and then you gotta play ball by all their rules/regs no matter how onerous they may be, and then answer everything to their liking, cross all "t's" and dot all "i's" just the way they like- it's a real skill and takes patience I'm sure.
It's easy to see why so many of these companies and commentators feel a lot of what our FDA does now is sorta run off the rails and has become a nightmares unto itself, while maybe not really protecting us near as much as people think, while at the same time stifling the things that really should be approved. I think that's why so many are calling for major reforms. But it's tough to dismantle or change a behemoth govt agency once it gets to big and powerful and becomes a "thing" unto itself. I think Leonhardt is sorta of fighting this cause, among others like financial stuff.
I'm gonna wait for the 10-K at this point since it's so close- wait and see what the big picture update is at this point and of course, be looking for Mirror info.
Just posted some links (long reads) along the same lines. The journal publishing part seems pretty clear-cut from a couple of the articles- as in the committee of editors "mandated" it, a while back.
Two of the links though were in conflict- as in one saying you still need U.S. based data ultimately for full FDA approval here. The other one stating there has been "limited", as in some drugs/devices approved now where all data was done outside U.S..
Interesting to say the least- but complex as heck, that much is for certain. I knew that already- dealing with the FDA is 2nd in complexity bar none. I don't even think the FAA or IRA is more complex, difficult to navigate. That's why there are people in FDA approval/regulatory positions, "hired guns" who make entire 20 or 30 plus yr careers out of doing noting but working for company's or as contractors or for contract firms in FDA interface and navigating the approval process- people with maybe a engineering or bio-science background, then maybe a MBA or law degree and maybe even another advanced degree or two tacked on- maybe even an M.D. or Ph.D. also. It's complex stuff to say the least. I've seen the info cited before - that a phase III, final FDA submission for approval can run THOUSANDS pages long, just a staggering undertaking, and then reviews and approval can drag on for year(s) often.
http://www.forbes.com/sites/theapothecary/2012/04/25/how-the-fda-stifles-new-cures-part-ii-90-of-clinical-trial-costs-are-incurred-in-phase-iii/
http://www.fiercebiotech.com/topics/fda_approval_process.asp
Of 5000 compounds discovered in the pre-clinical stage, only about 5 will make it through the entire FDA approval process. (WOW !)
New Drug Application (NDA)/ Biologics License Application (BLA)
If the drug proves to be safe and effective, the company then files an NDA or BLA with the FDA. NDAs and BLAs are typically 100,000 pages long and include results of human and animal trials as well as information on how the drug is manufactured. It usually takes the FDA 1-2 years to complete the review process and approve a drug. However, there are cases when approval can be accelerated.
(100 THOUSAND pages of documents, again, WOW !!)
Trials abroad- real interesting read. I was still wondering, if you do a trial outside the U.S., does the FDA "recognize" it as "enough" to allow you to submit for approval here. I decided to google some terms like, "off shore medical trials" or "trails outside U.S." and got a bunch of good articles. The following one I think is the best- the guy writing lists his resume at the end- and he knows what he's doing. He points out at the end of the very long article, that even though you've done a trial outside the U.S. and gained approval from that country's regulatory body- you still will need a U.S. based trial for our FDA to grant you approval, ultimately- that's my take/read on his conclusions. Which is an eye opener for me. As it means the off-shore stuff is just step-1, as in "trying" to open a marketplace, but if you want the granddaddy big "approval", meaning FDA, you still have to come back here and do it here inside our borders and get our FDA approval based on that data:
http://www.mddionline.com/article/study-abroad-tips-successful-clinical-trials-outside-united-states
"Effectively Positioning Technology for U.S. and European Trials
While the U.S. Food and Drug Administration (FDA) and the European Union (EU) ultimately require data on patients within their borders before issuing FDA clearance or a CE mark respectively, a trial conducted abroad in a credible manner can give a company a running start to securing regulatory approvals these markets."
Several articles under those google search terms, also seemed to strongly indicate that registering the trial on the .gov web site is still the standard practice and norm, even when it's being done outside the U.S..
http://www.janssenrnd.com/our-innovation/clinical-trails
http://www.nytimes.com/2009/02/19/business/19clinic.html?_r=0
http://www.esternmedical.com/information/article21.php
http://www.ncbi.nlm.nih.gov/books/NBK50886/ (very interesting below- it says committee to be published in a major medical journal, more or less mandated trial be "registered" on .gov site)
Clinicaltrials.gov
The Food and Drug Administration Modernization Act (FDAMA) of 1997 mandated the creation of the clinicaltrials.gov registry for efficacy trials in serious and life-threatening conditions and interventions regulated by the FDA. Developed by NIH’s National Library of Medicine (NLM) in 2000, it allows interested parties to find information on both completed and ongoing clinical trials. The database includes federally and privately supported clinical trials, and study sponsors are responsible for submitting timely and accurate information about their studies.
The database registered a modest number of clinical trials in its initial years (Figure 2-1). A dramatic increase in trial registration came in 2005 in response to the newly introduced International Committee of Medical Journal Editors’ (ICMJE’s) requirement that studies published in their journals be registered in clinicaltrials.gov or other equivalent publicly available registries. The Food and Drug Administration Amendments Act (FDAAA) of 2007 created a legal requirement for the registration of trials of drugs, biologics, and devices, generating a modest increase in the registration of trials over what had been seen in 2005. Given the increasing number of trials registered on clinicaltrials.gov over time, the database encompasses a broad spectrum of research organized by study sponsor (industry, government, and nonprofit), disease and treatment being studied, and trial design.
Lastly was this one- a REAL LONG READ, but interesting, in that it said that indeed, there has been "some" as in a limited number of new drug candidate/devices approved now by the FDA where the entire patient set and trials were done totally outside the U.S., though it appears it's still not accepted or preferred as the "norm" and certain countries seem to carry more weight than others- most notably W. European, as of course their standards and methods would be most closely aligned with U.S. practices. As you can see if you choose to read it- this FDA approval stuff is daunting to say the least, as in mega-complex and daunting. I can see why it takes a big staff normally, and real experts with mega-FDA-regulatory experience to navigate the gauntlet. It's real complex stuff/laws.
https://www.law.upenn.edu/live/files/2257-wilson34upajintll6412013pdf
Interesting- we'll see I guess.
Just saw on BHRT "trials" tab on their web site that Mirror does indeed have a label, "Up to 35 sites OUS". So, guess that "OUS" is an official position then- N. America but no U.S.. So that answers part of the question(s).
Still, not sure if it relates to not registering the trial though if the "end game" is indeed, full FDA approval of the trial results and ultimately FDA stamp of approval to market/sell the product/process inside the USA? And again, if registering on clinical trials.gov relates to ability to get published in major journals, still seems pretty dang important? Again, real question seems to be, WHY NOT register it - there seems to be no downside, other than you must pass "approval/review".