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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".
Good info- thanks for digging in on that. But let me please raise a few questions per last part of the statements:
1) Is it a definitive "given" now that Mirror is "outside U.S. now to save money"? I don't know if that's an "official" company PR and given position, is it? The original Pr regarding Mirror was that is as follows: "The MIRROR trial is fully funded by Bioheart and will be conducted at up to 35 centers in North and South America. The trial is designed to enroll up to 126 patients over a 12 month time period. The first patient has been enrolled in Mexico at the Hospital Angeles with the Regenerative Medicine Institute (RMI). This study will complement the data completed in the Phase II/III MARVEL trial on patients with congestive heart failure (CHF)."
I see the words NORTH and SOUTH America? I don't remember any official company statement that Mirror is now outside U.S. exclusively (N. America being Canada, U.S., Mexico, Central America)? But did BHRT ever say, the U.S. is excluded in this Mirror trial- I just don't remember that being officially stated anywhere? Could be wrong- but is that true and a blanket statement now?
Also, I don't think the FDA cares where you're doing the trial nor do publishers of medical journals- if you want it to be in the "big leagues" - from what I read on that .gov site, you register it. Again, I don't get any implied statement when I read that site that says in effect, "Hey, if you're doing your trial/study/data collection off-shore/outside U.S. borders, but still want FDA approval in the end, or major med journal publication, then just skip all this registering and getting the NCT number assigned stuff".
I'm just not getting that in my read of it? The way I read it- if you want to come back here one day, and sit across the table from the FDA and seek their approval of your product, then they want it done their way, in their system and all- no matter where you're collecting your data, etc. That's my read on it. I'm not sure how/why those concluding statements were made at the end of the post- seems like a pretty broad, lose interpretation of what they sent back? Again, that's my opinion.
Just the implications to how it could/can hinder your possibilities at being published in major journals, too me, is enough reason alone? In other words- WHY NOT REGISTER? It's free, it's relatively simple it appears- unless of course they didn't get granted approval by the reviewing committee(s), including the live human one? Other than that, what's the down side to registering? It's a win to be registered with no down side that I can see? Again, why register this "Macular" whatever trial, but then drop your big, flagship, phase II/III trial off the board? WHY? For what possible reason would that be a good choice/decision? I guess I'm still not buying the "it's outside the U.S." or the "it only helps to enroll people, we don't need it, it's voluntary" - it doesn't pass the smell test to me.
Last update we got was one, one single patient enrolled and that was from July last yr. If it was being tracked/updated on the .gov web site, seems we would know more, or the updates would have to be more timely.
Also, I'm still not sure what to make of that last part of the PR from the "one enrollment" announcement- it's odd to me, as if mentions FDA "hold" and "reviews" and so forth, and I don't think BHRT ever really answered or explained that in detail- not that I'm aware of?
"July 02, 2013 15:37 ET
Bioheart Announces Phase III MIRROR Trial for MyoCell Initiated
The FDA has placed a hold on the request for an Expanded Access protocol using MyoCell in part because the proposed expanded access study would likely interfere with the clinical development of MyoCell and/or interfere with developing market approval. Bioheart intends to continue enrollment in the MIRROR trial while hold items are addressed with the FDA. In addition, Bioheart plans to initiate part 2 of the MARVEL trial using the J&J MyoStarâ„¢ Catheter to deliver MyoCell to CHF patients."
That verbiage to me is confusing? They say they "intend to continuing enrollment"? As if the trial might be "on hold"? And then what ever happened to the Marvel, part 2 J&J and so forth? I don't think that's ever been mentioned again, has it?
More questions, than answers from my end? But that's me?
Personally, I wouldn't use/trust a bellsouth.net email address for any "official" corporate or other business communications- especially as related to a public traded company.
Company's in today's day and age maintain corporate owned/maintained web sites, and they do it for a reason. They also, nearly always list on said corporate site, the official path for "contact" or "corporate" communications. It's almost always (99% of the time) going to be an extension of the corporate web site domain name. When you have a main domain name, you get granted a block of email address to go with it- usually a 100 or more on even a "basic" web host plan. For $6 buck a month, the "daddy" site will host your web site and you get 500 email addresses to go with it, yep for $6 a month. In other words- when a biz or corporation has or pays to have a web site built and either a) hosted on their own servers or b) pays a legit hosting service a fee to host the site on their secure servers- you will always be granted a large block of email addresses to go along with that web site.
For example- all communications with Amazon will be in some form like servicedesk@amazon.com or investorinfo@amazon.com. All emails will end in the company web site domain. It's one of the common ways to spot a fake or phishing scam email from large companies. I've gotten things like replycustomer@4google.com or similar. That "4" being inserted is what makes it a 100% fake/phishing email.
The BHRT web site lists the following under the "contact" tab- and that's the only one I'd use/trust, again IMHO. bioheart@bioheartinc.com
Notice, it ends in the bioheartinc.com which is exactly what their main domain name is. That means it's a corporate owned, verified email address.
Sorry, but anybody can create a joeblow@bellsouth.net email via being on a bellsouth account. Not saying it's real or not- just VERY "uncustomary" for a company CEO to communicate on what, at best, would be a "personal", non corporate official email account. Again, the "standard" industry practice would be xyz@bioheartinc.com and EVERY email for every person or contact inside the company would be under that format.
My humble 2 cents.
Post previous listed link(s) direct to clinicaltrials.gov that explained a WHOLE lot more than that. Further, it does not mention "recruiting" or "enrollment" in that wording. It mentions to "provide information". More important though, would be journal publication, ethics, human trial review board and a whole host of other reasons explained very clearly on the .gov site. Links provided already in other posts.
Well, 21 days from first patient enrolled was what, about 6 months ago? Not sure what the question is/means?
Seems important to me to be on .gov site as a registered trial, and several posts just listed links that explain why- using the .gov site's own wording. Including a section specifically titled, "Why Should I Register and Submit Results?"
http://clinicaltrials.gov/ct2/manage-recs/background
That's a more informed, clear explanation than I've read in any post? Seems pretty clear to me and straight from the mouth of thee govt. agency itself- no middlemen or "interpretation" seeming to be needed?
I'm not "implying" anything- just stating facts and an opinion, which I'm 100% allowable and a legit thing to do.
Citing the .gov own web site, the statement "website is used for recruitment and general information purposes. " is 100% incorrect.
Previous post, posted the links to .gov site- it involves FDA LAW among other things when human subjects are involved, it involves being published in medical journals, it involves "ethics" (the sites own wording) and a whole host of other things. It does not, according to the site involve "being used for recruitment" as one of its primary or main purposes.
That's using the .gov site and its own info- which I trust a whole lot more than a potential private email from the CEO of a public traded company- when no one else appears to have been given the same, "material", pretty important info in many people's opinion. To be registered and listed on that site or not, is not a "trivial" matter for a major phase II/III trial seeking FDA approval- and that's not my opinion, that's based on what the .gov site ITSELF says and claims. Read the site and the FAQ and other info on it such as, "Why should my trial be registered/listed"- very informative reading.
Posts that "claim" to speak for the CEO or "the company" to me, are always suspect- when no one else has read or seen that same info publicly released. That's my opinion.
Reading clinicaltrials.GOV site- seems to me, you'd want to be registered if your trial is to be taken seriously?
http://clinicaltrials.gov/ct2/manage-recs/faq#charge
Note this line specifically under FAQ (cut n pasted):
Can I register a study after it has started, has closed to recruitment, or has completed?
Yes, you can register a study on ClinicalTrials.gov at any time. Please note that, in general, Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) requires Applicable Clinical Trials to be registered within 21 days of enrollment of the first participant. In addition, the International Committee of Medical Journal Editors and other journals require registration of clinical trials prior to enrollment of the first participant.
See FDAAA 801 Requirements for more information.
That sounds kinda important to me- as in, if you want publication later in major medical journals, sounds like they want your trial to be "registered" and issued the .gov tracking number and all? That's the way I read that verbiage above?
Again, strictly my opinion. But being published is huge, big in anything medical- it's what makes your work "peer reviewed" and more or less "legit" when the day comes.
Also, on the clinicaltrials.gov web site- read this section called, "WHY should I Register and Submit Results"- sounds pretty convincing and important to me:
http://clinicaltrials.gov/ct2/manage-recs/background
"What Is the Purpose of Trial Registration and Results Submission?
Registering clinical trials when they begin, providing timely updates, submitting summary results, and making this information publicly available fulfills a number of purposes and benefits a variety of people."
Read the table of info that follows that- pretty important stuff to me, especially for something like a "Phase II/III" and it doesn't mention A THING about "cause it helps recruit" and "we have enough people so we don't need it" or similar? It lists a whole bunch of, what sound like real, real important reasons to me, why a company with a major, serious FDA type trial would most certainly want it registered/approved on the .gov site. NOTE: Under FAQ link above- it notes that if human subjects are involved- the trial must be submitted AND "approved" by a review committee to be assigned a trial tracking number and appear on the .gov web site. Kinda important I'd think?
Quote cut n paste from same page .gov web site:
Why Do I Need To Register My Trial and Submit Results to ClinicalTrials.gov?
Required by Law
Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) (PDF) requires Responsible Parties to register and submit summary results of clinical trials with ClinicalTrials.gov. The law applies to certain clinical trials of drugs (including biological products) and medical devices. For more information:
See FDAAA 801 Requirements to learn about Responsible Party, Applicable Clinical Trials, and deadlines for registration and results submission
See the Protocol Data Element Definitions and Basic Results Data Element Definitions to learn about the specific data elements
See History, Policies, and Laws to learn about other relevant laws, including the Food and Drug Administration Modernization Act
View the online presentation
Key FDAAA Issues (9:23)
Deborah A. Zarin, M.D., Director, ClinicalTrials.gov, NLM
Discusses key issues in the Food and Drug Administration Amendments Act related to registering trials and submitting results.
Required for Journal Publication
The International Committee of Medical Journal Editors (ICMJE) requires trial registration as a condition for the publication of research results generated by a clinical trial. ClinicalTrials.gov is a registry where organizations and individuals can provide the World Health Organization (WHO) Trial Registration Data Set required by ICMJE.
See ICMJE section of Support Materials or visit http://www.icmje.org.
Selected Trial Registration Laws and Policies
A summary of key laws and policies requiring clinical trial registration are shown in the table below:
I find that reply vague/weak in my opinion. You go to the BHRT webt site and under the "clinical trials" tab they list 5 trials. Angel, Marvel, Mirror, Myheart and Regen. You then go to clinicaltrials.gov site and what I find under a search of "Bioheart" is Marvel (described as active- not recruiting) and something called Biowhittaker going back to 2006, then what appears to be "REGEN" maybe - it's last update was back in 2007 and then Pulmonary Disease one they created in Jan 2014 (see, they list that but not Mirror, why?) and then the Seismic one with last info/update, again clear back to 2007 and finally the Dry Macular one created in Dec 17th 2013. So they list that "Dry Macular" thing, which isn't even their forte or supposed main focus, but Mirror is not registered?
Makes no sense to me- there is no agreement between the BHRT web site "clinical trials" tab and the clinicaltrials.gov site. Then certain "new/small" trials are registered at .gov while Angel and Mirror don't even appear? Confusing to me to say the least. WHY would you register some, but then give the explanation that others don't need to be registered, cause you know, "It's voluntary and all and helps recruit, but we got plenty of recruits, blah, blah, blah?" I'm not seeing it. Again, why does everything they seem to do have to fall under the vague and inconsistent "umbrella"? Always bothers me- just my opinion.
Then you have this PR from clear back July last yr, which is confusing to me to say the least- it's the one that mentions "one" and "the first" patient being "enrolled" in Mirror, and taking place down in Mexico, but has all this other verbiage about it "might" um "conflict" and some kind of "hold" with the FDA on something else- but Mirror will continue to "enroll" (not necessarily go forward) as these "issues" with the FDA are "worked out"? Again- confusing as all heck to me. Then in the meantime- you get the medical tourism "stuff", you get the ED, erectile "stuff" you go back to a phase one of 5 people called Angel in Mexico when you were all the way to a phase II/III in the same product line? And ALL THIS with what was listed in last 10-Q as 4 full time people I think it was? And we know one of those is the CEO and one other is the sole, "Chief science officer"? It seems just running one, one single major trial would be more than one "Chief science officer" could handle- and she's also listed as the "CEO" of Stemlogix, and as a active managing member, CSO of "Ageless". I mean- come on, there's only so many hours in a 24 hour day.
Here is the last big Pr I saw on Mirror- and it's confusing to me- I don't really think the "we don't need to be on clinicaltrials.gov" is a great explanation- again in my opinion only and the way it "rubs" me- which is not confidence building or positive. You have nothing to lose by being registered on .gov- and every major company conducting major FDA type trials seems to be on there- so why not just put the "trial" on there? What's to lose?
Here is PR with "hold" and "conflict" wording and all the rest (note- we're talking NINE months ago now):
July 02, 2013 15:37 ET
Bioheart Announces Phase III MIRROR Trial for MyoCell Initiated
SUNRISE, FL--(Marketwired - Jul 2, 2013) - Bioheart, Inc. (OTCQB: BHRT) announced today the successful enrollment and randomization of the first patient in the Phase III MIRROR Trial using MyoCell® or muscle derived stem cells.
The MIRROR trial is fully funded by Bioheart and will be conducted at up to 35 centers in North and South America. The trial is designed to enroll up to 126 patients over a 12 month time period. The first patient has been enrolled in Mexico at the Hospital Angeles with the Regenerative Medicine Institute (RMI). This study will complement the data completed in the Phase II/III MARVEL trial on patients with congestive heart failure (CHF). Patients are randomized into either the treatment (2/3) or placebo (1/3) arm. All patients will receive delivery into the damaged areas of the heart using the MyoCath® Catheter. Data endpoints will include safety, exercise capacity, quality of life, and ejection fraction at 3 months and 6 months. Kristin Comella, Bioheart's Chief Science Officer, said, "We are hoping to achieve results similar to those from the MARVEL trial in which patients improved almost 100 meters over placebo in their exercise capacity test. We believe this therapy can address an unmet need for cardiac patients."
The FDA has placed a hold on the request for an Expanded Access protocol using MyoCell in part because the proposed expanded access study would likely interfere with the clinical development of MyoCell and/or interfere with developing market approval. Bioheart intends to continue enrollment in the MIRROR trial while hold items are addressed with the FDA. In addition, Bioheart plans to initiate part 2 of the MARVEL trial using the J&J MyoStarâ„¢ Catheter to deliver MyoCell to CHF patients.
Again, my own experience- and that's just me and my opinion perspective- is these guys put out a lot of "PR" and "blogs" and other "stuff" that somehow, just never seems to materialize later or move forward, or be spoken of in detail again later in a 10-Q or similar. I've seen it over and over again. Notice the last line in the PR above- about Marvel being "initiate part 2 with J&J blah, blah"- meantime, they do Angel instead, medical tourism, and 5 or 10 other things and it's almost a yr later- and we haven't heard much about Mirror, let alone some "Marvel part 2 J&J" taking place or advancing? I just find them scattered all over the map (literally geography wise) and spread across so many things- it seems impossible they could ever complete one of them with the staff/money they have? I just don't see the end game or where's it's all going? 4, maybe 5 full time employees- none of who have ever brought a major FDA approved product to market- and they're doing all this stuff from Mexico to Honduras to the Middle East to running multiple FDA "trials" and all? Really? I don't know- I sure got my doubts. I practically have to build a spreadsheet of all the PR releases, what they said they would be doing and where on what date, when, etc and then "try" and see if we've ever gotten any updates later on most of them, any revenues, any progress, etc. It's that complicated to me- to even keep track of.
But that's just me. If others want to get all excited about a PR about every 2 weeks or so- to each his own. I just see it all getting more "scatter shot" and convoluted and "off message" with each passing day? Oh, and that's not even mentioning Stemlogix and all the "animal" stuff they used to mention- what ever happened to all that? Oh well- we'll see what the 10-K says, it's the next "biggest update" coming down the pike. See what it says- and if all this "stuff" is mentioned and described in detail?
Interesting. I'll check it out and give a watch. Didn't think the film went that much into all that. That's right up my alley of interest.
Have you ever seen "Man On The Moon" with Jim Carrey? It's the life story of famous comedian (and REAL weird guy- Andy Kaufman who went from stand-up comedy to playing on TV series "Taxi" among other things).
It's a great flick- won't do a give-away, film wrecker in case someone hasn't see it and wants to. But in it he seeks "treatment" down in one of the, to say the least, wild "clinics" in Mexico. Very well done scene. That film is an old fave of mine- Jim Carrey to me, when he plays other people is brilliant, he literally became Kaufman and the film is funny as heck too boot.
Check it out too.
What's in "Dallas Buyer's Club" that would make you think I should watch it? I have not seen the movie? I haven't paid much attention to films this yr. If I remember the guy is sick/gets sick HIV or something?
What would be in the film related to what we discuss here? Thanks.
Well I hope so- the name is BIO HEART, as it seemed that heart applications was always the end game, and of course FDA approval if in any way possible- the big, huge end game payoff.
Just see what I'm saying - they seem to sure be getting off (use an old golfer term) "in the weeds a bit"?
I just hope Mirror is not stalled out. 10-K is the big, next update- so we'll see. Just seems like relatively few resources, chasing more and more of a scatter-shot approach. Old approach seemed more intense focus, stay on target and go for the goal line in the cardiac, FDA "trial" arena?
Just throws me off a bit, that's all.
Again, my experience is it is rare for the "patient" to PAY A LARGE ($5000.00) fee to participate in "research". Usually, it's the other way around- you are actually paid compensation to participate in the trial (time, travel and even a daily fee for your time/effort).
Again, it's just my opinion- but charging $5K a pop for a "trial" sounds more like a money maker, than actual "research". They also toss around the word "treatment" a lot in that PR. Again, do date, there is only one, one FDA approved stem cell "treatment" in existence that I know of. Also, that "Repair Stem Cells Institute" is another one of these "things" that appears to be nothing more than a web site and a rented office suite. They state- they are basically an "advocacy" group to promote stem cell "whatever" and "wherever" - whatever that means? They make all sorts of claims that stem cells "treat" all these numerous conditions- nearly every serious illness in existence, but according to the FDA that is not the case at all? Just go to the pull-down tab on that web site and look at "conditions TREATED by stem cells" - it's like a wash list of every malady known to mankind and wreaks of a vitamin or snake oil like hype IMO. Just under the "A" tab is alzheimers, ataxis, autism, arthritis, ALS (Lou Gerhigs), anti-aging, etc, etc- I mean come on, you gotta be joking. There is ZERO proof that stem cells "treat" any of those conditions?
Just doesn't rub me the right way, and again- why do this now and where is it supposed to lead? To a phase I or II or what? What happened to Mirror? Who of the 5 or so employees is "working" on all this "stuff" from Honduras to ED to now diabetes to also being a CEO of Stemlogix and Ageless and all the rest? How can so few people, with so little money possibly be doing all this and where is it all supposed to lead or what is the end game?
Only my 2 cents again, but I just don't see it or get it. More like attempts to keep the stock mo-mo pumping going than anything else to me. But that's just me. A
Obviously? Can you please point that out as a fact? It's not even clear from the Pr who's doing what, where and how? It seems BHRT is providing the cell extraction and culturing part maybe, then this TC outfit or whoever they are, are doing the "treatment/procedure" in a place called "somewhere" as far as I'm reading - and charging $5K a pop minimum to each "participant"?
Help us out here if you can parse and decipher the exact wording differently, please. I'm just getting a lot of confusion reading it. It does not seem like BHRT is actually sponsoring or leading or the one "doing" the "trial/treatment" or whatever it is, but is a "co-participant" in it with other people and taking place "somewhere"?
Not clear to me at all- again, just my read on it. Sorta confusing?
Misleading headline in my opinion. "Researching" or "studying" something is NOT "treating" it, as there are no approved "treatments" here (USA) via the FDA or in Europe or any major, developed nation that we are aware of, involving stem cells and type 2.
Further, I'm always suspect and leery of "studies" where the participants are charged a large fee ($5K or more) in this case, to "participate". All credible, legit research studies (medical) that I am aware of- are paid for by the company doing the research or a govt. grant or a major university hospital and endowment or similar. When the suffering patient has to pony up cash- then I don't see it as a "study" IMHO.
This to me just falls under the ole medical tourism banner or a variation thereof. It doesn't really say if the final act of "treating" (injecting the cells) is going to be done off-shore or not? I'd think that this can not be done on U.S. soil without being a full, FDA type trial- which it does not appear to be from what I get from reading that PR.
Just my take on it. I don't think this kind of stuff if helping BHRT. I'd rather see them stay on message and track with major, FDA compliant/registered, actual "trials" like the Mirror trial (the big one- the one everyone thought was "it" and the end goal/game).
I just don't get where they are going with seeming to dip into everything from ED (erectile dysfunction) to eye issues to now diabetes to Honduras to who knows what? It's getting more and more confusing to me. Strictly my humble opinion. Where is Mirror? How can ONE Chief science officer and maybe 4 or 5 full time employees manage and oversee what, what must be 10 or 15 different "undertakings" now at this point? Just Mirror alone is enough to consume every dime and every waking hour of a mid-sized pharma or similar company- meaning probably a staff or 50 or more people and $10's of millions of dollars.
Not seeing it guys. Just not seeing it. Waiting for that 10-K I guess. This PR doesn't do much for me personally.
Agree- your version of "reading the 10-K" is pretty much an exact copy of mine. I'll read page one for present share count and compare to last 10-Q. Go down to balance sheet and look for "cash and cash equivalents" on hand. Then start reading the "financing" activities section to see if, what you describe as "toxic financing" is still going on, and how much- as in "convertibles" (that is the magic word). I usually open the 10-K in my browser and use the "search" document function and just search for every instance of "convertible" and read those lines first.
Also agree- getting those revenue "channels" and streams flowing is no slam dunk or easy undertaking. Will take time to build up to the $250K or $300K a month or so they need just to hit there day to day cash flow needs. So, will look for updates on "tourism" and other deals and did any revenue come from them yet.
Yep- good summary of how to read/examine this 10-K. I'll pretty much be doing the exact same "scan/read" method you will use.
We're all waiting for it- wanna see where things are at. If expectations are too high right now, it might let some air out of the tires. If it's got some good news in it- then we'll see. Oh, and of course we'll all be looking for Mirror. That will be the other key word I'll do a fast search on after I open the document. That's a big one- everybody is waiting to see what that one says. When I read the last 10-Q, I gotta admit I was a bit "miffed" to say the least, that the Mirror sorta got a boiler-plate at best, kinda passing mention. That sorta blew me away. I did a double check and researched the document- but it just wasn't there. It was near word for word what was in the 10-Q prior to that. So that Mirror is the big one that I think everyone is waiting to read too. Yep. We'll see.
Cash on hand, shares sold and new share outstanding count, financing activities- how much, what type, "toxic" or not; new business deal/adventures generating any income or not, and MIRROR. That's it in a nut shell for me.
Well, pretty much agree- "twitter" can go both ways. It is what it is- a communication "tool" that blasts out 140 characters at a time and any tom, dick, or harry can be on it, in under about 30 seconds of sign-up time.
Just saying- I'd go easy on putting too much behind "tweets". Not knocking it 100%, just saying I'd not put it as the end all, be all. Think of it as just another tool- maybe in the old days it would have been an email tool and real old days a newsletter or something. See what I'm saying?
I personally, again, just my lousy 2 cent opinion, think "twitter" like most "fads" will pass. As I stated, I already know young people who think Facebook is dead and buried, who were now on twitter but are jumping off it in droves and now it's snapchat and instagram and if you look- there's about 20 new (literally) start-up, "hot" trending variations on all of thee above picking off users. The latest is services where you form your own sorta little "private" groups now- the old trend was be as public as possible, now the kids/teens wanna go secret and private. Very fickle.
So, tweeting is a tool. I think they are in PR "push" mode and just testing the waters on using all these tools- like putting out "tweets". Remember, you can tweet all day long, but it doesn't bring in cash or make the biz a success or sell things at the end of the day. I know very successful businesses and they don't give a rat's behind about "tweeting" or anything else- they just run and work their businesses hard like they always have and build sales and profit the hard way- face to face, shoe leather on the ground, pounding the phones, etc. Lots of tools out there- tweeting is just the latest variation on them. Again, my 2 cents.
Not knocking it one way or another- it obviously reaches some people as you are a perfect example. You've read the tweets and it gave you some info to ponder. So from that stand point- it has "worked" to some extent and served some purpose. What it does for the biz in the "big picture"- I think is harder to know or measure. So, tweeting to me is not too exciting or doesn't move me too much one way or another- but we're all different and like different things, ways of communications. I-Hub is a perfect example- kinda a "private" way to discuss stocks, yet public. They built a little "community"- very similar idea to tweeting and facebooking, etc. Lots of "stuff" out there for communicating today- to each his own. Good luck.
Only problem with that is, I don't believe there's ever been a single indication that the "private placement" (carefully worded to say "up to" $20 million) ever went anywhere.
All indications from each 10-Q has been that BHRT has been doing nothing but paying "Northstar" back money as interest and loan/debt payments. And most recently, I believe that all, Northstar insiders are converting out some of the debt to equity (recent SEC docs posts showing how many shares each one got).
So I don't know what to make of that? Personally, I've seen BHRT put out a lot of similar PR/statements in the past, only to never hear of them again, or see anything materialize from them- just my take on it, but I've made that observation many, many times with these guys. In other words, search deep in the 10-Q's and see if any mention of that "private placement" or any specific new "capital funding" has ever shown up since that PR/blog about Northstar "private placement"- I don't believe you will find anything. In fact, as stated, it's the other way around- BHRT has been paying back to Northstar each period.
The only "funding" sources I'm aware of have come from direct sale of shares by BHRT to various "finance houses" and that's what's accounted for the outstanding share count rising by over 100 million shares in less than the past 9 months or so. I can't find any other source really of money injected than that by reading the SEC docs?
The idea that Northstar could go out and "easily" raise a chunk like $20 million or so in the investment climate of the past few yrs would be daunting to say the least. The value of BHRT market cap has not even been close to that amount until only the past few weeks and the climate for capital raising has been tough, other than using debt because interest rates are so low. But to use debt, you have to have assets which they really don't have. I know people in the "private equity" biz, these are guys with unbelievable pedigrees: like Stanford undergrad at top of class on full scholarship, then ran various businesses as CEO/buy-out specialist for a while as a "turn around expert" then Harvard MBA, published author, been on CNBC (woke up one AM - and there he was on TV with a new book he wrote being interviewed, I was like- I KNOW THAT GUY), rubs elbows in the D.C. area and Georgetown with filthy wealthy people and the politically connected, etc. I ran into him fairly recently as I know his brother and I asked him how "the biz was, and was going" and his exact words were "it's tough and tough sledding right now and not like it was back in the go-go days". He recently sold off a mansion (literal mansion- Architectural digest featured and all) and has down scaled a bit- flying commercial first class versus private jet, $3.x million dollar home after selling the $10.X million dollar home- you know, really cutting back lol. When he comes into town to visit his family- he's always in a rented Range Rover or BMW SUV or something, goes and plays golf with key people (always doing business no matter where he is- and he was a near pro level golfer, Stanford golf team n full ride scholarship on golf)- it's "elbow rubbing" endlessly in the "capital raising biz"- this guy's rolodex (modern cell phone contact list) must be an amazing site to look at. He shows up in socialite mags and newspapers throwing a party at one of his mansion homes or with his artwork collection or wine tasting hosted event- and it's nothing but mega wealthy name dropping going on, people who can light their fireplace with money they're so loaded.
No knock against BHRT, but if you look at who's in charge of Northstar- the guy, as far as I can tell, has zero experience at ever doing a "private placement" and/or going out and raising significant capital. I won't name names, but you can easily look up which guy it is, and what kind of business he had/has and ran- it has nothing to even do with technology or bio-tech. So, how that kind of guy would just hit the streets, and approach high net worth individuals to raise a big chunk of money (which is what a private placement is all about- you have to approach people with certain, minimum net worths, minimum high income levels, etc)- how that guy could pull that off to me would be very surprising. As stated, the people I know that do this full time will tell you it's a brutally tough biz, and they rub elbows with the who's who, they run entire "funds" they build/raise for private equity and so forth and host endless mansion parties with the "in crowd" to get money sloshing around, etc.
So, I don't know that the "$20 mil Northstar placement" ever amounted to anything. Nothing I have read or seen tells me it went anywhere. That's my take on it- so I'd read that with a grain of salt IMHO. My opinion only- maybe someone else knows more about it- but I'd think if any of that money did come in, it'd be plastered all over the past 10-Q's, and I just don't see it.
A public traded company, when in "compliance" with basic "SEC" laws (SEC being the U.S. Govt Securities and Exchange Commission- the govt. body that regulates and enforces the laws of our public stock markets)when they are a "compliant" company- one key thing they do is issue/register/report certain important documents with the SEC.
Note- one problem with some "penny" stocks traded on the OTC- over the counter market or "Pink" sheets unlisted stocks market, versus the NYSE, New York Stock Exchange (nick name Big Board) or the NASDAQ, the other "big" stock exchange where "listed" stocks trade- one problem is that sometimes penny stocks no longer are "compliant" and do not file documents with the SEC properly. Not filing on time or in compliance is in fact one of several reasons that can get a stock "de-listed" from one of the "big boards" like NYSE or NASDAQ which are the most prestigeous and desirable places to trade as a public company. Whew- that's a long explanation, but anyway, that's it in a nut shell. One of the complaints, reasons you will here about why a company may not "want to go public"- is that the INSTANT they do, they fall under tremendous scrutiny and reporting laws governed by the SEC. Many remain "private" companies as they do not want all the hassle of reporting to the SEC. You can raise capital as a public company- but it comes at a big price of reporting, being legally bound, etc. I've worked for a company that had a $billion plus in annual sales and was still a private, essentially "family" owned company- 100 plus yrs old, and no desire to go public. They can run the company their way and don't answer to anyone but themselves, their employees, and if they have private investors- they only answer and report to them as agreed upon. Once public- a whole new ball game and a book of laws as thick as a phone book.
Good news is, that even though BHRT (Bioheart) presently trades on the "Bulletin Board" unlisted exchange as basically a "penny" stock- they, as a company, have made the choice and effort to remain "SEC compliant" and are still filing the necessary documents on time and as required.
So, the question what is all these words "10-Q" and "10-K" mean? They are the quarterly company report (the 10-Q) and the annual, end of yr company report (the 10-K report). It is the philosophy of the U.S. public markets- that as a shareholder in a company, you are entitled to know certain things about them, their financial info, certain business info, etc. That is what these reports serve to do. If they are of high quality, they are typically "audited" - meaning a neutral, 3rd party, licensed CPA or public auditor firm has gone over the document and also put their "stamp of truth" on it- saying that whatever the CEO or Chief Finance officer or others in Sr Mgt said in it, in deed is believed to be true and accurate. A CPA firm or similar, as well as, the CEO or whoever signs off on a 10-Q or 10-K is under a "fiduciary" duty to the shareholders that what is in the document is true and accurate- and it's not to be taken lightly as it can result in financial fines and, up to and including prison in worst case scenarios if lying takes place in reporting- and yes, people have gone to Federal prison for "cooking the books" on SEC documents (famous cases being big companies you probably saw in the news like Enron or MCI/Worldcom the phone/long distance company, Lehman Brothers- once a huge Wall St. brokerage and banking firm).
Anyway, that's what the 10-Q, 10-K is all about. It allows us, the common stock holder to read, and know a lot about the financial health of a company, it talks about current business undertakings, problems the company may be having, etc. It serves to allow you to help to perhaps invest and want to own shares in the company or not. It typically contains a "verbal" description written by Sr. Mgt, as well as, what in business is known as a standard "set of financials"- which any businessman/woman is familiar with and normally is made up of: a) A balance sheet- a "snap shot" of things like cash on hand, accounts receivable, cash owed on accounts payable- basically a summary of what a company "owns" and what it "owes". The most fundamental equation you learn in accounting 101, or MBA 101 is: Assets = Liabilities + Shareholders' Equity. That is what the balance sheet does. It totals out all the pluses the company owns, and all the debt it owes, plus shareholder equity and should balance out each side of the ledger. b) The next document in a financials is typically an Income Statement or "P&L" profit and loss statement, which is just what it sounds like, a statement of whether the company has income coming in, where it's coming from (selling product for example),etc and what is going out being spent, essentially sales or money coming in, versus money going out(sales or cash coming in versus costs/expenses owed going out) and is there a net "income" or a net "loss" for the business and c) A statement of Cash Flows- which is very important as it shows whether or not the company is "throwing off enough cash" on a day to day or month to month basis to pay it's day to day operations without borrowing or financing activities and similar.
That's a lot to swallow, I know. You may want to get an intro to investing in stocks book- many will have a good section on how to read and understand the basics of a company's financials and their 10-Q and similar SEC reports. A guru like Warren Buffet is so good, so experienced- he can "glance" at a "set of financials" and pretty much decide if the company is in good financial health, is in trouble, whether they have costs that are too high, or have finance problems, etc It's like the instant "snap shot" of the total financial picture of the business.
Here is a link to the BHRT documents. Most people use a service called "EDGAR" which is a main, public repository of all the SEC documents put out by public traded companies. Click on some and read through them- it will give you an idea what is in them. Scroll down and you will see the last "10-Q" and if you go back to March 2013 or so, you'll see the last 10-K, which as the other post pointed out, would actually be last year's (yr 2012) full yr report.
We are all chatting here so much about the 10-K that's coming because 1) It's due any day now if it's "on time" (the SEC sets dates per a company's fiscal yr as to when they need to files key documents- think sorta like taxes due by April 15th each yr for you and I) and 2) We all want to read about the latest financial health, or lack of, for BHRT- such as how much cash they have, how many shares of stock they may have sold to raise cash (known as diluting shares), is there new income coming in from some recent business undertakings they have spoken about, and latest updates that management will write to "tell us the story" in their own words of how last yr "wrapped up" for the business.
That's a long explanation- but explaining "what is a 10-Q" is a pretty complicated explanation to someone totally new to the stock markets. Happy learning and good luck. Here is the link to all of BHRT's SEC reports:
http://www.sec.gov/cgi-bin/browse-edgar?CIK=0001388319&action=getcompany
I'm fine with "Fully Funded by BHRT", just add the next page/sheet with the details. A little breakdown. Don't want to overwhelm people with some CPA/MBA level analysis, but a little "detail" I think is all people want. A one pager summary sheet. Again, cost per patient, timeline approx., where they expect the money to come from/be raised from and spread out over X number of months.
Kind of the "bullet-point", Powerpoint one-pager. People like pictures or summary bullet-points that sort of lay out the "big picture". Then, when they, if they choose to read the 10-K or similar- they can say, "Ah-ha, yep- here's that cost break down, and here's that equity line or shares sold- I'm cool with that as they laid that out real clear in that presentation."
People just don't like uncertainty or vagueness- again more info is better than less (of course within limit- as I said, don't give um the War and Peace Vol II version, just the one-page summary sheet in a clear, easy to understand plan). People like clear "plans" and then the updates you give can show how you're "on-plan" or give you the chance to give an update and say, "We've deviated from PLAN here, and here's why due to X, Y and Z coming up, so we're making adjustments to the plan". Then people say, "Oh, they're not pulling a fast-one on us or hiding anything- they're just clearly adjusting the plan, and it all makes sense and it jives with what they laid out for us before".
Again, that's my 2 cents. I just think for many people it builds a more confident base and understanding- they may not be as confident as you or have followed the company for as long, etc. They may need to see the long term vision and plan to feel it's a good time to put money on the line and buy-in.
Wishy-washy camp for me too. But for different reason. The part I don't like is the "fully funded by BHRT" type of statements. Now STAY COOL guy's, it's not a "bash", just a legit question. When your last 10-Q showed about $6K on the books left, the logical question to me is, "fully funded HOW?"
A more "common" industry/CEO type response I prefer to see is along the lines of, "We expect the XYZ trial to happen in 3 stages. Stage 1 enrollment is expected to be complete approx XY/2014 and we estimate the cost to be approx. $12K per patient and will enroll 120 patients. Or, this type of trial is being structured where participants will pay a partial fee to be in the study and BHRT will pay the remainder. Stage 2 will be the trial itself and will be conducted at sites, X, Y, Z and A, B, C and we estimate we need to fund each of those site at a cost of $X dollars per patient for the duration of the trial, expected to last 6 months approx and have a total cost of Y dollars. Final stage, stage 3 will be our final data report and compilation and will be done with in-house resources and also via contracting to firm ABC and we estimate this to cost X dollars and terminate approx. 6 months from last patient enrolled. The funding from this will be done via our XYZ stand-by equity line and also via equity sales of shares estimated to be approx X shares over 9 months, which yes, we expect to be partially dilutive, but we believe this is a key step in the company's progress and needs to take place, blah, blah, blah. Our estimate at this time of total cost of the Super-Duper trial is $1.3 million dollars and will be spread out over a 9 month period."
See the difference? See how that would make investors and the professional community so much more confident that they totally know where you're going, how you think you're going to get there, etc? "Fully funded" to me, is a pretty much nothing statement. All it leaves for us, is to wait for something like a 10-Q or 10-K to come out and then hope to find how many more shares were diluted or if we can find more borrowing or where money might of come from and so forth.
Not a big, confidence building statement in my opinion- and that's all it is, my opinion. I've seen big companies, lay out big announcements- and they get a CEO right out there with a Powerpoint presentation and all- to the investment community and show the timeline, expected cost/investment, whether it will be dilutive to shares or earnings per share (obviously not applicable to BHRT at this point), are they going to borrow bond debt, etc.
The more vague you are, the more I think it leaves you open to volatility and people maybe throwing in the towel, people thinking it's stalled out, etc. More info is better than less. Vague= lack of confidence in my book. "Wishy washy" is a good wording to me.
That's pretty much what I'd expect him to say. Talking about a key, trial enrollment and progress/potential lack of progress is about as "material" as it gets. I'd guess he's gotta tread real lightly there. If he's saying wait for 10-K, that pretty much tells me he doesn't have a whole lot of "major" news to give on it yet- or they'd put it out in a PR. As in, lets say they finished total enrollment- I'd think that is about as "PR worthy" an item as you can release, but they can't release it until it's true of course. So he's telling you he can't speak on a major, material event like a trial via private communication and doesn't expect anything on it till the 10-K info. Makes perfect sense to me. So, guess it's wait and see time. The other theories/opinion on "medical tourism" as a potential revenue source (several posts from different people) - I can buy all that as reasonable arguments.
I think they're in a tough spot, so my opinion is don't sugar coat it or overblow it. Cash is tight- I think everyone would say that's a given. But are they trying to "work the problem" from all angles and maybe pull the magic rabbit out of the hat? Yes. If you and I ran a biz and we were say, focused on "Widget Making Inc", but were in a tough econ times or whatever and tight on cash- and we realized that we had the people or facility to make some good, cash money by shifting over at least for a time to "Happy services XYZ" would we do it? I think so. Nothing in biz is cast in stone- as in biz plans, long range plans get revised/updated all the time as times and econ challenges arise, etc. So maybe this is "the new plan" for now and they're working it to see what it can do- while the trial(s) are still there, but cash is the big driver and they have to find out how to get more of it. All reasonable theories/possibilities to me and makes sense.
Does it all work out in the end? If anyone has a brand/model number of a crystal ball that works, guaranteed- send me info cause I want to buy one ASAP and get filthy wealthy. Remember "Back to the Future" with Micheal J. Fox where he finds the Sports Score Statistic book- from the future, well the past really- and realized he can bet and win every time as he now knows the outcome and score of every game before he even bets? Man, what I'd pay to have that, eh?
No sweat. Info is good, more info is always better. This ain't our mom n pops stock market anymore- that much is for certain. It helps for people to understand who/what people like an "Asher" are, or how these private networks can be used, or what it might mean when you see some of these broker/dealer house name/symbols pop up on level II and how much power than can wield around (It wasn't that long ago- that the "little guys" weren't even allowed to see Level II, or you had to pay a small fortune to buy a subscription to get access to it- so at least we got that "fairness" and leveling of the playing field now). But remember, whatever we can see/know if trading actively- a firm like "Asher" or any pro-street firm has 100X the info and speed and access that a retail investor will ever have. Remember the day it went to .063 faster than people could blink? That had to be, in my opinion, one of these big boy firms "cleaning house" or doing whatever it is they do- and the little guys were standing there essentially blind as that "flash crash" happened in minutes. That's a lot of power when they can drop a stock so hard, so fast and no one knows were they short, or selling for someone- or what the heck happened. If we had the same info and speed they had- we'd have all bought that bottom and gone long in a blink- but it's hard to even get orders to fill sometimes when it's moving so fast- you'll see that complaint pointed out here a lot of the time. How people put up an order and these brutal broker/dealers just sit on it, until they can get you up or down to the price and "spread" they want to "make their cut"- it's a brutal game they play. Companies don't get in bed with um cause they're nice guys- it's just that sometimes you gotta do what ya gotta do as times are tough. Good luck.
So are you seeing the "medical tourism" as a specific move, biz decision to enter that space? I posted a few posts back- it doesn't raise any concern they may be getting spread a little thin across too many projects and losing that FDA trial- go, go, go to completion? Any thoughts?
I can see the "medical tourism" as an attempt to generate a "side" cash generator to get money coming in- but they just seem to be getting spread wide and over a lot of territory. It then can pull it off- it's the magic rabbit in the hat. But I would still say I'm a little (not sure the word- disappointed/miffed) at the loss of the previous clear and constant msg that FDA approval was the end all, main game. They used to pound that out constantly- phase III, driving for the end goal of FDA approval in U.S. Just seems that msg is a bit watered down now?
Could all be due to the cash squeeze- and they're just trying for what they can to find revenue sources while trying their best to push trials ahead- I just wonder if the big trail doesn't sputter and peter-out, which was sorta the Marvel problem. That trial had charged ahead full force, made it to phase II, heading to III, then just died out- and in the 10-K and similar they pretty much stated it was only from "lack of funding". So that's the constant pickle they seem to be in. The more a trial moves to phase III, the more money it needs- like the monster that grows as it moves further along. Starting Angel phase I is easy as it's 5 people, but how much cash can/do you need to get it moving now to the next step?
All roads seem to lead back to cash- and there can never be too much it seems. The more the better. We'll have to see I guess- can some of these ventures be the new cash-flow generators?
Interesting article just popped up, sort timed well with the who is ARCA question. It's about the HFT (high speed traders) who for the most part- invented and developed those "private networks" like ARCA you're asking about.
http://finance.yahoo.com/news/high-speed-trading-firms-face-001700904.html
If you ever want a real interesting read- like mind blowing in my opinion, go to Amazon and look up the book "Dark pools" by Patterson or "The Quants" by Patterson- Amazon will also show other similar books that readers "liked" in same category. You can probably get a copy at a local library- it's mind blowing stuff as to how brutal Wall St really is behind the scenes and what has evolved into this "electronic trading and hedge fund/blind pool" stuff and what it's done to distort the markets. As in how can/does say someone like an "Asher" often do what they do- as in going short a bunch on convertible shares, often being able to crush a stock price to dirt- all for their own fun and pure profit and personal gain, with "little guys" never having a chance or knowing what truck just ran um over.
An interesting guy to read and listen to his commentary on all this is the BILLIONAIRE ole Mark Cuban- who made his fortune on internet companies, now owns the Dallas Mavericks among other ventures and is on Shark Tank the TV show- he openly HATES this electronic trading, HFT high frequency stuff and thinks it's the bane of the markets now- destroying the original purpose of the public capital markets, who's original intent was to help aspiring companies raise needed cash, allow real investors a chance, etc. Not to allow a bunch of boiler room dudes who use MIT math geeks using some of the most sophisticated computer networks on earch to shave pennies off of trades, or "head fake" orders to drive stocks down in a blink, or crush entire companies in short plays and so forth. He's written some real good stuff on all this.
Just interesting you asked about ARCA and who they are as they are popping up with BHRT order flow - and then this HFT/private trading network article pops in today- might be a good read you'd be interested in.
I am almost certain ARCA or Archipelago would be the Archipelago Exchange/network. It's one of many, private "networks" where "big boys" can use/send order flow to match a buyer and seller. So it could be a place where the broker/dealer or an Asher like firm is sending some big order flow to get a "match" and make a sale. Those networks are very hard to decipher. Read up on "dark pools" and the like- those private ECN (electronic exchanges) are used a lot of time to make sales for a big client who doesn't want to be identified. Or, it can just be firm XYZ who wants to sell or buy and happens to be a member of that electronic trading network- and can use it to route order flow over to look for a "match". Hard to say. Are you seeing what looks like big selling or share volume stacking up on it? That would maybe indicate someone trying to move a large chunk for a big boy. Also, these broker/dealers have an entire bag of brutal tricks they use (think Asher) where they can "flash" orders up on these networks to get panic selling going, or go short, then they pull that order away- never intending for it to even fill, then "flash" it out their again to mislead people that a big sell is sitting out there- there's all kinds of games/shinanigans that go on. Hard to say just by seeing the broker/dealer symbol or network symbol like ARCA. Some of the real "boiler room" broker-dealer otc/pink symbols are notorious and real well known and tend to be a bad sign when you see them roll into view. But ARCA as far as I know - is someone using that network to route some order flow. Google ARCA, Archipelago network. I will say- it's a well known network for hedge funds and big, private trading firms to use, that's pretty well established- what their motive is in this case and are they buying or selling a chunk for someone can be real hard to decipher with what us "little guys" can see/know.
Agree. The 10-K can only include new things from the past 3 months, ending on Dec 30, 2013. All 10-Q and 10-K are essentially back-ward looking for a 3 month period and take a few months to compile and release- so recent events aren't even in them (sometimes little updates are amended at bottom- but for the most part they cover that 3 month, past tense period). And the 10-K is sorta the grand, yr end compilation and summary of all the yr's 10-Q's rolled up into the final, end of yr last 10-Q plus a summary of the entire yr as mgt sees it.
So yes, you can't expect it to reflect instant results for some PR news event, say released, one month ago- that's too soon usually to be put in this qtr's info and make it in the 10-K covering to end of last yr.
That balance sheet analysis was only to try and show what my estimated (and I think I'm pretty close- it's not a certified CPA analysis by any means, but just a look at the numbers they put out and some simple math)- but it was to try and show what is classically known as your "burn-rate" or cold, hard cash needs.
To try and give some idea how much money, actual cash, they need as a business to show up, pay people, keep the door open and lights on, and most importantly service their debt- that's the big one to me, as it's the one that can get you shut down, put in default if you can't pay it.
As you can see- the amounts aren't trivial. Needing about $250K a month coming in for operating the biz, and maybe as much as another $50K a month to pay interest and service the debt is a sizable chunk of change- and that is what Mike (he's the guy primarily in that hot seat each month) that's the reality he has to face and juggle each month- or it's lights out.
When you look at the share outstanding increases from about the past qty-3 10-Q's, the number of shares sold off to raise cash is not out of line at all with that $250K to $300K a month number. When you figure the stock then was only about 1 penny sometimes to maybe 2 or 3 pennies and they have to offer Asher and others a discount on the shares too boot- you can see that they could easily have needed to give up 100 million shares to "pay the bills". Example: 100 million shares at say .02 (BHRT's portion say after discounting to an Asher like firm)- that would bring in 100 million x .02 per share = about $2 million dollars, which just about jives with that 9 month usage of about $250K X 9 months or about $2 million to keep everything going.
So they need cash, and they need it on a continual basis. Those ventures and deals announced are more than likely an attempt to "try" and start to stave off that cash-burn need, but IMO will take time, a fair amount of time to ramp up to generating a couple $million a yr. In the mean time, if they need to keep seeing Asher and similar, I'd expect periods where, as we saw before, the stock can get hammered pretty hard when those "big boys" decide to unload a chunk of their shares, or worse, go short on the other side of their trade- which is their "style/known tactic" to get themselves even more money. There are detailed, well written articles about Asher and the like- they are brutal dudes. They don't lend wanting to make 5% or 12% return like your bad credit car loan place. They aren't happy till they make like 25% return or more in ea deal. High risk, high return and they're very good at what they do. Why does BHRT and other companies use them then? Well, sometimes you're just in the squeeze and hurt locker for cash- so you bite the bullet and do what you gotta do while hoping your other plans pan out and work out.
I'm still concerned can they really get the FDA level trial stuff really moving. It takes a lot of money- as in a LOT. When you go back a while- BHRT seemed to have a singular, very clear message that moving to an FDA trial completion was their total end game- and obviously to anyone owning, thinking of owning the stock- that was where everyone knew the mega big return or payoff would be. My concern is, they seem to be drifting off that focus and message into a lot of different "stuff"- just my opinion. It may be that they're just tight for cash and moving a 100 plus person trial ahead is a big cash user. But not hearing about Mirror and not seeing it the primary, main focus and instead seeming to shift almost to a new, "medical tourism" or some sort of hybrid company offering "treatments" around the world- struck me as odd and a little off-message/disappointing. You look back and read for yourself- you can kinda "feel" when all the news and updates and PR seemed to shift from FDA trial, FDA trial, FDA approval to now lots of other things being talked about, batted around- which also has to take the time of the chief science officer and others away from the trial(s).
Look at the other question posted that mentions the Baxter trial- that will give an idea what they face in terms of the 10,000 lb gorilla in the room. Baxter can toss a $100 mil down a drain, this instant, and it's a rounding error on their balance sheet- and they have 60,000 plus employees to use to do whatever they want to do. That's what BHRT is up against.
So yes, the game is "tight" and they're in a competitive, tough field to play in. And that month to month or qrt to qrt cash is the lifeline. Remember- Northstar was formed and had to step in as BHRT did go into default on a key loan (I think the Bank Of America loan) - which means they came really, really close to BK. Luckily some of the insiders stepped up to the plate and must of put up some kind of collateral- my guess, their homes/businesses, personal savings, etc to guarantee and extend that loan from being "called in" and putting the lights out on BHRT. One of the 10-Q's explains it in detail- that the key loan did go default and Northstar "assumed" it- which to me, is language that they stepped in and "guaranteed it personally".
So be reasonable on the 10-K, yes. I think you will still see a fair amount of new shares have been issued, increasing the outstanding share count a lot and I wouldn't be surprised that cash would be low again and tight. All just an opinion, educated guess- but that's based on the past yr of 10-Q's and other info.
I agree- building up expectations way to high, adds to the violent price swings and can cause a big sell-off when the story doesn't come up instant roses when they put out the real details- which is always the SEC document. Good luck.
The phase III you are referring to is a BAXTER TRIAL. It's clearly stated on the Temple web site and on Baxter's site.
http://www.templehealth.org/content/news.htm?page_id=7&minor=2&inCtx5pg=0&inCtx5news_id=236&inCtx5news=2&site_id=1&inCtx5order_by=S:%5Bstart_date%5D%20desc&major=4&inCtx5view=35
Note the disclosure, bottom of Temple page: "Editor's note: Neither Dr. George nor Dr. Houser has any financial interest in Baxter Healthcare Corporation."
He doesn't give a BAXTER disclosure because the trial is for BHRT??
http://www.baxter.com/press_room/press_releases/2012/02_28_12_stem_cell_cmi.html
It's pretty cut n dry. Has ZIP to do with BHRT and is not even the same technology- it's bone marrow derived cells. All explained in the links above. And no- the researcher is not under some "mystery" name- he's listed all over these PR's and it's FOR BAXTER and THEIR TRIAL.
"Trading in $BHRT shares = easy cash to bank almost daily, got it?" Don't have any idea what FACTS exist to even remotely back up such a statement? In less than a week you have bag-holders underwater as much as 25% or more, getting in at .08, some down 50% only a few days ago. Further, for about the past 2 yrs, the stock was STRAIGHT DOWN or at best a "saw tooth wave" oscillating between about 2 pennies to 1 penny and going nowhere- with a large number of bag holders stuck in at .04 or above from the last "event" that spiked the price (similar to this past 1 week or so) and then collapsed it nearly as fast- never to recover for over 1 to 2 yrs. So "easy cash" is not based in any facts that I think can be proven? And "cash daily" is even more of a stretch- today being a perfect example. Anyone buying in the AM got buried down hard, by close of market. Statements of gross generalities are amusing, for sure. I guess that's why most, probably 85% or more of "traders" lose money on a consistent basis, many go full on broke- those are well researched, well documented market facts. Not even debatable- backed by academia research, market research by every major brokerage house, etc. There's no such thing as an "easy money to bank" anything- if there was, everyone on this planet would be filthy wealthy. Pull up a 5 yr chart of BHRT and a 2 yr chart- and "try" and make the case it's "an easy money in the bank" anything? It's a loss making machine. Right now, it's down about 98.70 or more percent from it's IPO. That might be a new record of some sort- except for those gone BK.
Will do. I plan to give it a good read, cover to cover. If there is revenue in there, will try and find it and see what impact it would have on starting to be able to off-set the present burn rate. Cash is KING as they say in biz. You gotta keep it coming in the door one way or another - the lifeblood of any biz endeavor. As a small business man for example, you can't open so much as a small dry cleaner w/o knowing exactly what you need coming in each month to pay the basic overhead, hopefully pay yourself a salary, etc. I know a lot of small biz guys in my neck of the woods- and I can tell you one thing for certain, they know TO THE DOLLAR pretty much, what they need each day or month on average coming in to remain solvent or else they don't pay themselves or cut their guy's hours on their crew or whatever. I'm sure Mike knows pretty much to the dollar what it takes to keep BHRT open and running right now. That to me is the pickle they're in- cash coming in, versus trying to "work" the biz and make progress. 10-K will be a good update since the 3 months of that last 10-Q. I did note- the 9 months 2013, versus the 9 months 2012 has gone up a bit (they always list prior yr along side current yr in a balance sheet)- and that jives/is consistent with what we know- that they added a few staff, they undertook things like the Angel trial, so the spending going up a bit yr over yr is right in line and expected. We'll see what's next.
How much would BHRT need to be free of dilution/share selling? Also, how lopsided is their SG&A to R%D spending (my opinion)? There has been talk/speculation that perhaps BHRT could generate cash and be able to stop selling shares to the likes of Asher and others for what essentially amounts to survival cash, continual/on-going. So I looked at the last 10-Q balance sheet numbers- just looking at cash used for overhead (SG&A) and R&D (lets forget interest on their debt for now- but that adds even more to their cash needs).
To be free of needing outside cash via selling shares, what would they need? Well from last 10-Q period ending Sept. 30, 2013 they had the following cash use entries on the balance sheet (essentially no sales or cash source from biz activities)- which, again excluding even interest costs, will allow the "burn rate/cash need rate" to be approximated pretty easily.
From 10-Q balance sheet:
For the 9 months ended Sept 30, 2013 Marketing, General Admin costs were $1,750.276.
For the 9 months ended Sept 30, 2013 R&D (think trials) was only $494,762
So they consumed $1,750,276 + $494,762 = $2,245,038 CASH in 9 months
That would make the burn rate about $2,245,000/9 = approx. $250K per month. THAT IS WHAT THEY NEED MINIMUM COMING IN A MONTH to be free of outside share sales/dumping, etc and remain solvent, w/o laying off people, cutting current spending,etc. And that's on the low side as is does not include interest expenses on their debt.
So any/all these 3rd world biz undertakings, PR news of "deals", etc would need to generate at least $250K a MONTH coming in direct to BHRT at this burn rate to even get close to breaking even. There has been speculation that this could happen "soon"- personally I see it as a long shot, no way I can see anything recently announced getting them this kind of coin coming in this quickly, my opinion.
To give an idea of interest expense on the debt: Under supplement to cash flow activities page on balance sheet- they list interest paid on debt, for 9 month period ended Sept,30 2013 as $513,986 (just a bit higher than amount paid in same period 2012- so it's consistent).
That amounts to $513,986/9 = $57K PER MONTH.
That would bring the MINIMUM MONTHLY CASH NEEDS TO approx $300K PER MONTH just to break even and remain solvent, out of BK by paying their interest due, etc $300 THOUSAND A MONTH. That's about the magic number at this point per the documents- else you have to cut costs somewhere, get someone to allow you to delay paying interest- or you're insolvent pretty much.
What's also interesting is how little they spend on R&D in ratio to SG&A (salaries on 4 or 5 people, rent, general overhead, etc)- it's pretty out of whack in my opinion. A typical R&D to General Expense ratio of a healthy biz - giving some examples:
Lowe (a researcher) found that Merck ($MRK) spends 27% of its revenue on SG&A and 17.3% on research and development. Pfizer's ($PFE) ratio is even more lopsided, with 33% on SG&A and 14.2% on R&D. Smaller, more biotech-focused companies have better numbers; Biogen Idec, for one, spends 23% of its revenue on SG&A and 24% on R&D. That's partly because--we suspect--specialty drugs don't require the armies of sales reps sent out to support primary-care meds.
By contrast- of the approx budget for that 9 month period, BHRT spent about $1,750,276/2,245,038 = approx 78% ON SG%A (SEVENTY EIGHT PERCENT- to pay themselves, pay rent on a small office, etc. Just seems way out of whack to me- but that my 2 cents)
And about only $494,762/2,245,038 = approx only 22% on R&D
(Again, that doesn't include the additional $50K, a big chunk, they spend on debt service (interest) each month)- but it shows they don't spend much of what they generate/take in, in cash on R%D which is the "trials" and all. I don't see how you can possibly get a phase III, FDA quality trial through to completion on anywhere near that low an R&D budget, let alone fund the people needed for all the functions that will be needed- a massive report/data compilation effort, possibly more trials if the FDA demands more, etc.
Those are the cold, hard numbers from my read of the 10-Q (most recent) and the balance sheets, where the money goes, etc. I just don't see them getting anywhere near being free of selling more shares on a continual basis at this point and I don't see how you'd fund a large, FDA quality, phase III trial with those numbers above- I just don't see getting from point A to B in my opinion. It's not unusual in the slightest, to spend $10's of MILLIONS on a phase III, even exceeding $100 MILLION would not bat an eyebrow in the pharma-biomed world.
That's my take financially at this point. Looking forward to the 10-K. Owe, and the cash balance at the end of those numbers above was only $6K approx. total cash left on the books. 10-K should be interesting to say the least- looking forward to seeing what it says.
After hours are not always what they appear. A lot of time they are "clean up" trades being painted from throughout the day. It's tricky to interpret after hours a lot of the time. I'm not even sure on the rules of the pink/otc for trading after hours- I'd have to look into it. But again, sometimes they are trades clearing from earlier in the day- that much I know is typical a lot of the time.
Finished at .0562 eeking out a 2% gain on high volume. Someone sold into that strength. One big dip after initial AM pop, then closing out back at that same point, or close to it.
20% swing in a single trading day doesn't seem anything like "normal" or "healthy" trading to me? Further, this was taken to .08 in a blink (less than a 24 hour trading period), then cut by very close to 50% almost as fast- again, not a normal trading pattern or activity in my book. On a listed or big board stock, that would trigger an investigation almost for sure. This thing is in what I call yank-n-bank trading to say the least. You have people buying in the AM, then underwater 20% or more by end of day, WOW. Interesting to see what happens from here- someone sure sold hard into the AM strength today. I don't think that was just little ole retail orders on that volume. They put out a LOT of options, insider shares, debt-to-equity shares and so forth in just the past several months (in addition to probably finance house shares and convertibles)- so, could be a lot of shares wanting to sell into a strength point. We'll see I guess.