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"Nice volume today. News coming??"
Huh??
"Nice" volume? It's TANKING TO THE DOWNSIDE, broken down completely below the 200 DMA for the 4th day in a row on higher than avg volumes? News of what? Going out of business?
It's selling-off on heavy volume- not exactly a sign of anything positive? The bid hit .023. The low today is .0225. It's gonna break 2 cents at this rate and volume unless a trend reversal happens. The market cap is back under $12 million, approaching their outstanding debt again.
What's with the, "The lower it goes, it must mean something good is happening or is supposedly about to happen or is supposedly imminent?" I've never, ever encountered this "new" investing reality, except in relation to BHRT? Most of the time, stocks and companies that are successful, experiencing success, that have good news breaking, etc- their stocks TRADE UP, and the more the volume goes UP when they trade UP = better.
When a stock trades DOWN and especially DOWN on increasing and on higher volume = BAD, not "good". Does BHRT trade in some alternate stock universe I've never read about or something? What am I missing here?
Well, there's essentially no retail shorting of penny stocks- so that leaves it to you know who? The ole pros and hedge folks and firms with trading desks or routing to the trading networks and so forth- who are often IMO, the very "finance" people they willingly got in bed with, IMHO.
Also, the total short volume as a portion of the massive number of outstanding shares is almost nothing. I attribute the situation to just pure dilution, cheap share "over-hang". Meaning, they, BHRT have handed out and diluted out so many shares in the sub 1 cent to 1 cent to 1.5 cent range- that there's always a huge amount of those shares to go on the selling block. For how long? Who knows, but I'd guess it can take near forever (years) to burn off selling 100's of millions of 1 to 1.5 cent shares, which from reading their SEC reports, IMO is a good guess at how many are "floating" around out there.
That's my 2 cent opinion. Pure effects of massive dilution and use of convertible, toxic debt financing, on-going, for years and years now.
2.5 hours into the trading day and it's managed to trade .0236 X 69K shares = $1,628 bucks.
Staying below the 200 DMA. Looking a little bit rough in here right now? Somehow always manages to go back to essentially being a "2 cent" stock and the market cap always seems to just gravitate back pretty darn close to whatever their outstanding debt is, IMO. Meaning the "market place" isn't assigning much, if any, real value to the "company".
What happened to the "big revenue" and all those PR releases about all this various "stuff" like "first ever" and all? Where's the big buyers and the big financing? I just don't get it?
Back below the 200 DMA after all that? That's confusing to me? People bought in March/April at like .08 and .06, where are they now? That's like a 50% or greater loss in under 5 months? Ouch.
I tried it on the weekend and it did go to GrXnXers little stem site? I thought he (Andy) was correct? GrxnXr owns the web sites of both (stemcellceo and investorstemXXX)- I can post the link where he states that. So it's no difference anyway. Grxnxr operated stemcellceo before, so I guess, he let it go or didn't renew the URL or whatever. The link appeared to just be moved over to his main little pay to join, penny stem promotion site, investorstemxXX. No real difference either way IMO.
What's interesting IMO, is all the old blogs appeared to have vanished been "scrubbed" for whatever reason? Wonder why he did that? Either way, blog, schmlog IMO, makes no difference- and it's not even hosted on the official BHRT site. Like why wouldn't they host it there IMO, if they want to place ownership of it for certain, and up front state it's 100% guaranteed to be by them and their content, etc? How hard would it be to put a "blog" page on your own main web site? A high school kid could do it in an evening for about $100 bucks probably. Why do they want it hosted off on a pay to join, penny promo site of Grxnxr's? Makes no sense IMHO.
"Recent blog"??
It's from March 2014, over 5 MONTHS ago now? That's not "recent", that's old info IMO. The most recent 10-Q just got released, which is "recent" and contains all SEC disclosed info anyone should want or need to know about the company. So what difference does some "blog" (not even hosted on the official BHRT corporate web site) really make anyways? What's a "blog" supposed to do anyway? Also, it's called the "CEO BLOG" on GrXnxrs little stem penny site, but then the CSO is the "blogger", not the CEO? Look at all the PR they push out, the twitter now, the facebook, the taking up residence on all sorts of penny stock promotion sites, paying $5K to a penny promoter recently (smallcapvoice), and all the rest and then look at the stock price and market cap? What one needs to know, the real story, is always in the SEC filings IMO; that's the data and info that count as far as I'm concerned. Like almost no cash left end of qtr as is typical for them, big raises for the same two people again while no money went to key phase II/III trials (including MIRROR, gone nowhere for "lack of funding", but those raises and big bonuses sure have "funding"), a pittance spent on R&D (about $5K lousy bucks a month), more massive dilution as in 50 MILLION plus shares in one qtr, continued use of toxic convertible financing, etc. None of that "pesky" stuff ever seems to make it into some "blog"- kinda funny IMHO how that works?
Look at the spread this AM, WIDE OPEN again at 6% to 8%. They're "trying" to hold it up, but the bid just dropped to .0236. Wow. It's looking like a down trend is getting set in place, IMO. 7 plus days now below the 50 DMA and now breaking the 200 DMA twice and staying there, it appears.
A clue to what? A link to a self made, paid penny promotion, 30 second video clip from 2011? None of which has come true to date IMO, and it's now late 2014?
(that video says 18 to 24 months to complete "those" trials- and that was in 2011. And NONE of it's happened that I'm aware of and no big "financing" has come forth in that time period, 3 yrs, either?)
What's the "clue"? So they're dredging bottom for old PR hype and stuff to push out using "twitter"- all while the stock is tanking big time on high volume? What's the connection? I don't get it?
Oh, and nothing about the clip IMO is "powerful" (that's what the clip claims, "powerful") and the "American Investor", if one searches, Googles it high and low- only shows up in a couple of BHRT self made promo videos. It's paid penny promotion IMO and made to "try" and look important like CNBC or something, complete with the nice little adding of the stock tickers for Pfizer and Cytori, neither of which had/have anything to do with BHRT. It's something a high school kid could crank out on a Macbook IMO. Maybe 3 takes with a $300 video cam, maybe 15 minutes video shooting time total and an hour of editing using a basic Mac. About as low budget as it gets, IMO. Look up the supposed host/interviewer, Kimberly whoever, her name appears in no other search results other than the couple of BHRT video penny promos for some invented (IMO) named "host" the "American Investor".
So, what is the "clue"? What's it supposed to mean? Does nothing for me personally? 2011 when this video was made- the stock price might of been maybe 10 or even 20 cents maybe on it's good days, and there was about 80 MILLION shares, tops, outstanding, versus now almost 600 MILLION shares outstanding, at 2.4 cents or whatever today's closing price was? Clue? Not seeing it?
From past 10-Q filing:
"As of November 9, 2011, there were 82,152,767 outstanding shares of the registrant’s common stock, par value $0.001 per share."
Latest 10-Q filing:
"Fully diluted shares outstanding were 588,670,163 and 290,900,920 for the three months ended June 30, 2014 and 2013, respectively "
WDCO is Wilson-Davis & Company. Look at the info and forms on their web site- they handle "professional" level clients it looks like, including those who got shares in what? DEBT CONVERSIONS (ring a bell?) and who may be "insiders" or have key "affiliations" with the companies for who they want to sell shares, etc.
Interesting as heck IMO, given all the recent debt-to-equity and boat loads of "other" shares being handed out for all various reasons and to all various people/entities (including insiders) by BHRT. For someone to utilize someone like this WDCO, would make perfect sense IMHO. But what do I know- I'm a rank amateur and guessing, but reading that WDCO web site and the forms they make one fill out, who's a seller of a large block of shares- is fascinating to say the least.
http://www.wdco.com/FORMS.html
http://www.wdco.com/SDR.pdf
http://www.wdco.com/DCQ.pdf
http://www.wdco.com/CAR.pdf
They ain't E-Trade or TD Ameritrade or something, that much is for sure, IMO. I always wondered who would handle selling say 10 million or 18 million shares or whatever for someone who wanted to sell them and somehow got them for something like "services rendered"- well, it looks like these guys are right up that alley IMO.
"No reason for this with the latest financials...revenue on the books this year for the first time. "??
The latest financials showed a net loss from operations nearly IDENTICAL to one year ago, period over period (See latest 10-Q page 5). (I believe it was $46K difference, less loss this Q-2 than 2013 Q-2, so "revenue" made essentially no difference as their spending/expense line entry has massively increased, including very large base salary and bonuses for two people). They finished the Qtr in this latest 10-Q nearly cash broke (typical for them), with $92K cash left on hand- less than in the same period in 2013, which had about $172K cash on hand, despite nearly nothing (about $15K) being spent on R&D for the entire qtr and no major trial(s) advancing at all (not Regen, or Marvel or Mirror). Again, what difference did the "revenues" make? They are still utilizing ASHER and similar firms like Daniel James and Fourth Man for toxic, convertible debt financing to sustain themselves, despite finishing with almost no cash left. What has changed in their "financials"?
They diluted over 50 MILLION shares in a single qtr this period between Q-1 and Q-2, 2014, again, what has changed? The share count is now well past 600 MILLION shares outstanding and 2 BILLION now authorized. What has changed?
Just because some new MM/Broker dealer house symbol shows up on level II, doesn't mean much IMO. Lots of people route orders for various stocks and for various reasons and for various clients. BHRT has handed out BOAT LOADS of common stock shares, as in 100's of millions of them in just the past 1 yr approx.- they're gonna get put on the selling block sooner or later by someone IMO. Who those holders of common shares use to route or handle their large order flows- as in someone holding say 18 MILLION shares they gave out (see past 10-Q, for an example of an 18 MILLION share block paid to someone for something like "services rendered" or whatever it was), who knows? One of these MM/broker dealer symbols could be handling order flow for one of these persons/entities that got one of these huge chunks of common shares or even warrants being sold/exercised.
Dilution, and lots of it, as well as, using convertible debt financing on a continuous basis has consequences. It, IMO, is the single greatest down-force on the share price and is as old as time in companies that dilute heavily and use convertible debt. It's nothing new going on here IMO. I doubt a couple of MM/broker symbols on level II are the cause of something "new"? Look at the way this has traded for the past several years- this is just "normal" IMO.
Here's just ONE example. Previous 10-Q, Q-1, 2014, PAGE 24:
"In April 2014, the Company issued 18,383,774 shares of its common stock for service rendered valued at $180,511."
18 MILLION shares handed out- and to who or for what, who knows? "services rendered", that's all it says. Do the math on those shares:
$180,511/18,383,774 = .009
Yep, 9/10ths of ONE CENT is what that "someone/entity" got those shares at. 18 MILLION shares just out there now, or at least as of April 2014, and they were given at under ONE CENT. Don't think someone might be unloading/selling those to more than double their money right here, in this price range? I know what I think? How long does it take to "burn off" 18 million cheap shares of "over hang" on a stock with daily trading volumes as low as this one, and what does one think happens to the price when large blocks of shares go up on the sell side? The price action- given those shares were issued in April, doesn't surprise me one bit IMO. Not in the slightest. I'm surprised it's not under more selling pressure IMO.
15% spread in 17 MINUTES of trading (last trade 9:47 Eastern- almost 1 hour ago now, low of .0225 on open)- gotta love the MM's on this baby. Sell/dump days on high vol with the spread tightened to like .024 bid and .0243 ask yesterday, breaking hard to below the 200 DMA.
Today on 36K shares traded (36K X .025 avg say = $900 bucks), yep on $900 bucks total traded, they swing it through a 15% move. Wow.
A 15% swing from the open, and now the bid is .0244 and ask is .0264, getting Grand Canyon wide as is typical IMO on the low vol "move it back up days". Gotta get it back up in that range to set-up to dump the next large block for their client, I guess? It's fun to watch how the penny MM's can work this thing, to the tee. Pretty impressive what an MM can do on these penny nano-cappers.
The 3-4 month chart is a real hoot right now on this one, IMO. Going nowhere, with about a one month, high volume dump cycle to below the 200 DMA, when "someone" appears to unload a block like it's on a set schedule or something? Those sharp dump lines on higher vol are amazing to me- I'm trying to time/measure the intervals, they seem "set" or pretty much planned possibly IMO?
Since the March/April PR run-up, it's only down about 50% now, maybe a bit more depending on when one bought. So a 50% loss in only about 4 months, that's not really bad as an investment I guess? And it's gone really pretty much nowhere for about 3 to 4 months now- hanging flat, at or below the 50 DMA. Now breaking down below the 50 DMA and heading closer it looks to the 200 DMA possibly (like it did late May and early June). A few more days under the 50 DMA (it's been about 7 now) and it's probably a confirmed down trend, IMO.
Just a little TA/charting viewpoint.
"Agreed getting rid of convertible shares while they still can"??
While they still can? Who is "they"? What prevents them or could prevent them from getting rid of shares they have converted? The shares belong to them? Who can stop them from doing that? Unless the loan/note underlying the convertible is paid back, then the financer has the right to convert the debt to shares at the stated discount. If they've already done the conversion- then the shares are theirs, they own them and no one can take them from them and they can hold them or sell them, whenever they want?
They make money whether the price goes up or down, makes no difference to them? If the price goes down, then they convert and get even more shares. If the price goes up, then they convert and sell at a profit also- it's the entire reason the toxic financing is designed the way it is, the "house", aka the ASHER'S of the world, they can not lose on these deals, they make money, and lots of it no matter what.
What would it even mean, to be getting rid of them "while they still can"? What could/would happen that would prevent them from "getting rid of convertible shares"?
And THERE'S THE DUMP- figured it was coming any day now. Said it before, when it languishes for weeks on low volume, high spread days, where the MM "tries" to hold it up, using mainly the wide spread, then it typically is setting up for one of these high vol sell-off dumps, IMO from observing it in the past.
Every time for the past month or more, the days it's "up" like 5% or 7% or whatever, it's been on very low volume and mainly using the spread. Then, it sells off back to the 50 DMA or so, on 2 or 3 times the volume of the "up" days. This goes on for like a month- and then, looking at like a 3 month chart, you'll see that about every 30 days or so, maybe a bit more, it dumps off hard on high volume, breaking even the 200 DMA. What we're seeing right now. Like clockwork.
I think somebody is still unloading a big holding- there's just so much low price share overhang from all the dilution IMO. Who knows how long it can take to unwind all those shares? Plus, they're still adding more dilution every month, every qtr, just read any of the recent 10-Q reports. And still using the likes of ASHER and similar for "financing" on-going, thus those shares typically get converted at some steep (45% to 47%) discount at some point.
It's about a 2.5 cent stock and the market cap is back at under $12 million, which is barely equal to their debt. Not much has changed for years, IMO. Just more dilution, lots and lots of dilution.
From the latest 10-Q filing, just some examples of how many shares they are issuing out each qtr (about 50 MILLION dilution between Q-1 2014 and Q-2, just a 3 month time frame)
Most recent 10-Q page 25: (bunch of shares handed out- dilution, about 10 MILLION shares just in these couple of lines of the 10-Q)
"Subsequent issuances
In July 2014, the Company issued an aggregate of 1,006,451 shares of its common stock for services provided.
In July 2014, the Company issued 155,677 shares of its common stock in settlement of accounts payable of $6,227.
In July 2014, the Company issued an aggregate of 6,985,495 shares of its common stock in settlement of related party notes payable, accrued interest and other obligations in aggregate of $279,419.
In July 2014, the Company issued an aggregate of 2,640,625 shares of its common stock in settlement of notes payable of $32,500."
And then, same 10-Q, PAGE 15, an "ASHER" type convertible note deal (toxic financing) w/ a new company called "Fourth Man", for $50K. That's how bad they need cash, they're doing these convertible notes for as little as $50K cash at a time. Page 15:
"Fourth Man, LLC
During the six months ended June 30, 2014, the Company entered into a Securities Purchase Agreements with Fourth Man, LLC. (“Fourth Man”), for the sale of an 8% to 9.5% convertible note in the aggregate principal amount of $50,000 (the “Note”).
The Notes bears interest at the rate of 8% to 9.5% per annum. As of the quarter ended June 30, 2014, all interest and principal must be repaid one year from the issuance dated, with the last note being due June 26, 2015. The Notes are convertible into common stock, at Fourth Man’s option, at a 47% discount to the average of the three lowest closing bid prices of the common stock during the 10 trading day period prior to conversion. The Company has identified the embedded derivatives related to the Fourth Man Notes. These embedded derivatives included certain conversion features and reset provision."
Lots and lots of dilution and common shares just "hanging" out there IMO (all documented in their own SEC filings), shares that someone is going to sell and flip to get their money back, and make a profit on it too boot, IMHO.
" MMs won't let us run"?
MM's, aka "market makers" don't "let a stock run" or "not let a stock run"? That's not their function. They, the MM's" do just what their name implies, they "make a market" in a particular stock or many stocks. Meaning they're there to match buy and sell orders and when needed, provide liquidity/inventory when a mis-match occurs, insure an orderly flow and execution of orders, etc. They make their money "on the spread" between the bid and the ask they quote.
http://www.investopedia.com/terms/m/marketmaker.asp
http://www.sec.gov/answers/mktmaker.htm
If anyone is "not letting it run", then it means there are more sellers than buyers, and typically, nothing more complicated than that. Other than perhaps, in the case of a company like BHRT who regularly relies on the likes of ASHER and Daniel James and Fourth Man, etc for convertible share death spiral financing on a regular basis, it "might" (though they're not supposed to supposedly, but many believe they all do it one way or another, aka Asher, etc) it "might" mean some shorting of the stock also. Because the lower the price goes, the more the death spiral, convertible debt "finance house" will profit. Look at the recent 10-K/10-Q filings for BHRT, the "financing deals" using convertible debt are giving 45% to 47% discounts on the shares if converted, using the "reset" provision- that's the part that reads something like, "the conversion price is determined by the average of the trading price over the 10 days prior....".
http://www.sec.gov/answers/convertibles.htm
http://www.investingadvisers.com/finance/articles/the_mysterious_world_of_death_spiral_finance.php
http://hartleybernstein.over-blog.com/2014/05/at-death-s-door-death-spiral-financing-the-name-says-it-all-it-conjures-up.html
The stock selling off and going nowhere essentially is not the fault of some MM. It's the reality of not much buying and more sellers than buyers.
Look at who and what that "Maxim Group" does- they include wealth mgt and investment banking services among other things. They might be the very people being used by some of the insiders or large "mystery" shareholders to unload large blocks of shares for um, IMO. BHRT has handed out 10's and 10's of millions of shares of stock for all sorts of stuff to all sorts of people- just read the 10-K and 10-Q filings: Everything from "notes payable" to "accounts payable" to "for services rendered", it's all over the place in the SEC filings. When a large insider holder or a "big boy" holding say, some of the 50 MILLION warrants that BHRT handed out like candy, or who got one of these 5 million share or whatever blocks for something like "services rendered", when they need to sell, they don't typically open an E-trade account or something IMO. They're gonna, IMO, use exactly someone like this Maxim Group- someone who has a trading desk probably or connections to one, who has a main-line to the trading networks, etc. That's how it's done.
Who might be selling? Who knows? BHRT handed out, aka diluted over 200 MILLION shares in just the past approx. 1 yr and a boat load of warrants too- so the common shares floating around out there in someone's hands are huge, and many are priced at like 1 cent to maybe 1.5 cents (same for warrants, someone could exercise their warrants at strike prices of maybe 1.5 cents or something like that- which means BHRT does get some cash, but there is also more huge dilution then). Someone, IMO, could easily still be selling in this price range in large blocks- as they'd still be doubling their money or better, if they'd gotten their shares at the 1 cent range, maybe 1.5 cent range.
Dilution HAS CONSEQUENCES and convertible debt "financing" using the likes of the ASHERS of this world, HAS CONSEQUENCES. There's volumes written about it on the web by professionals, including the SEC and similar agencies.
Here's the I-HUB 'ASHER" page someone put together- a great explanation of what typically happens to stocks of companies who make use of the likes of ASHER and similar firms and convertible debt to finance their operations:
http://investorshub.advfn.com/~-ASHER-~-25451/
Volume "kicks in" on selling days- like clockwork, for over a month now. The lower vol days are when the MM opens the spread wide-open and tries to creep it back up to the .0275 to .03 range.
If you look at today, the volume is now much higher than the past week, and it's trading hard to the downside, well below the 50 DMA now and about to touch the 200 DMA. Not a good sign IMO. It's been under the 50 DMA for going on 4 days now, and now when it drops big, the volume finally increases. Someone's unloading again IMO.
The "golden cross" talk makes zero sense IMO. A Golden Cross as far as I remember would involve the 50 DMA making a sharp up-turn and cross above the 200 DMA and on higher vol. That is not anything like the trading pattern of BHRT for the past month or more, and not what it looks like now? So not sure where that's coming from?
On a 6 month chart- the stock has gone nowhere and is off big time from the March-April PR run-up and has now been flat to treading water for at least 3 months, bouncing between the 50 DMA and some sharp drops to as low as the 200 DMA, some even breaking the 200 DMA. It just hit the 200 DMA of .024 just now, on much higher volume than the avg volume of this past several weeks- where it's been barely breaking 200K shares a day on avg many days.
Pretty much been dead money and in decline since March/April and we're heading into Sept. now.
4500 shares traded, over 1 hour into trading day, then took 1.5 hours to finally have a reasonable size trade and hit 64K shares. Trading at or below the 50 DMA now.
That's 4500 X .0265 = $119 bucks. That's anemic volume, IMO.
64K X .0265 = $1,700 bucks, about 1.5 hours into day.
Wonder what happened to that "big financing" deal? The site where superwhatever made all the predictions about 30 days after the 14C and this means imminent "big financing" and "chime" and Northstar and insiders would be "forced" to "give up" their preferred shares- which has not happened and all this was going to happen and be certain by such and such date, all of which have passed now, as we head into Sept? That 14C was on 4/28 and now it's going to be September? All the insiders and ole Northstar are still holding all the preferred shares and holding the exact same number they were since they were issued to them? What happened I wonder? Where's that "big financing" hiding? Or is the increase to 2 BILLION authorized shares just like all the past 14C's - for continued dilution (they hit 600 MILLION shares latest 10-Q filing), "employee benefits" and "other" corporate purposes as the BOD deems necessary from "time to time"?
From the 14C, filed 4-28-14, PAGE 51:
"Material Terms, Potential Risks and Principal Effects Of The Increase of Authorized Common Share
Our Board of Directors and the consenting majority stockholders have adopted and approved resolutions and an amendment to the Articles of Incorporation to effect an increase of the number of common shares of the Company that the Company may issue from nine hundred and fifty million (950,000,000) shares of common stock and twenty million (20,000,000) shares of preferred stock, both $.001 par value respectively, to two billion (2,000,000,000) shares of shares of common stock and twenty million (20,000,000) shares of preferred stock, both $.001 par value respectively. The Board of Directors and the consenting majority stockholder believes that the Increase in Authorized common shares is in the best interest of the Company and its stockholders because the increase in the number of authorized but unissued shares of Common Stock would enable the Company, without further stockholder approval, to issue shares from time to time as may be required for proper business purposes, such as providing for reserves that are often required when and if necessary to raise additional capital for ongoing operations, business and asset acquisitions, present and future employee benefit programs and other corporate purposes as we make every effort to become cash flow positive.
The increase in the authorized number of shares of Common Stock could have a number of effects on the Company's stockholders depending upon the exact nature and circumstances of any actual issuances of authorized but unissued shares. The increase could have an anti-takeover effect, in that additional shares could be issued (within the limits imposed by applicable law) in one or more transactions that could make a change in control or takeover of the Company more difficult. For example, additional shares could be issued by the Company so as to dilute the stock ownership or voting rights of persons seeking to obtain control of the Company, even if the persons seeking to obtain control of the Company offer an above-market premium that is favored by a majority of the independent shareholders. Similarly, the issuance of additional shares to certain persons allied with the Company's management could have the effect of making it more difficult to remove the Company's current management by diluting the stock ownership or voting rights of persons seeking to cause such removal. The Board is not aware of any attempt, or contemplated attempt, to acquire control of the Company, and this action is not being presented with the intent that it be utilized as a type of anti-takeover device."
"present and future employee benefit plans"- gotta cover those recent big salary increases for two people AND bonuses AND all those option grants with something, somehow, I guess, IMO? Makes sense to me.
Last 10-K filing, end of 2013, PAGE 71:
See the "compensation table" there (page 71) and then the additional recent base salary and bonuses in most recent 10-Q filing. Tomas is now at well over $1 MILLION annual, total compensation package, for running a near cash broke (about $90K cash left end of Q-2 per most recent 10-Q filing), 2.6 cent stock. When he took over the stock was about .50 cents or more per share. It's now at about 2.6 cents and has been massively diluted in that time period. I mean, a bonus and huge salary increase makes sense to me. A decline from .50 cents or greater price per share, to 2.6 cents now with a end of 2013 low of 6/10ths of one cent and at least 10X the number of shares outstanding now- shoot, that's performance based of course, IMO.
From past 10-K filing:
(The number of shares outstanding of the registrant’s Common Stock, $0.001 Par Value, as of May 10, 2011 was 42,600,569. )
Today, over 600 MILLION shares outstanding and climbing. And NO, there's been NO "big financing deal" in that time period (2010 to today) that I'm aware of? Dilution? Yes. "big financing" other than highly dilutive and using ASHER type deals and similar? No, IMO that I know of?
Mayo Clinic, NOT Bioheart? Also, it's cord-blood stem cells again- nothing even remotely to do with BHRT?
It's trading below the 50 DMA today on anemic volume. Wonder if it's time for a "PR" about something? It's been longer than normal IMO, since a PR release?
Sure. So that's why the "adviser" Edward Diethrich, M.D. is NOT any longer the "Director of the Arizona Heart Hospital" as listed on the BHRT OUT OF DATE INFORMATION- and in FACT, the "hospital" went BK and does not even exist anymore as in the past, let alone has "Diethrich" as it's supposed "director"??
Google makes it too easy. Really.
http://www.medscape.com/viewarticle/726311
http://www.bizjournals.com/phoenix/print-edition/2012/01/13/heavy-heart-noted-valley-surgeon.html?page=all
Those to articles are far more UP TO DATE than "2008" and the info they present DOES NOT MATCH the claims of the BHRT web site. Doesn't get any clearer than that IMO. Not complicated. How can he be the "director" of a hospital/facility that went BK and then is also said in the other article to have "LEFT" as in NO LONGER IS THERE, at said Hospital? How can that be?
I'll pick another random name off the list and do the same.
Lets see, how bout Ray Chu-Jeng Chiu, MD, PhD. The BHRT "adviser" web page says he's "Professor of Surgery McGill University Quebec, Canada ".
Well, lets say he WAS, as in PAST TENSE, because he PASSED AWAY on Jan 4, 2014. That's about 8 MONTHS AGO. How's that 2008 DATED information working out? The guy is no longer ALIVE, but I guess he's "current" as an "adviser" to Bioheart? Fascinating?
http://www.jtcvsonline.org/article/S0022-5223(14)00127-5/abstract
http://www.legacy.com/obituaries/montrealgazette/obituary.aspx?pid=169019299
Yeah, "current" as of TWO THOUSAND AND EIGHT. Simple as that, IMO.
""As of 2008" is not out if date"??? Huh?
A statement on a web page such as "as of Jan 2008" means THAT IS WHEN THAT PAGE WAS UPDATED. PERIOD. It's like saying the "time right now is 1:30 PM" or "This book was printed on Jan 1st 2008". It's plain English.
There's nothing to debate- the information is 6 plus yrs old. Look up the names- and see if they're even at the locations listed in that table.
Jan 2008 was right before the IPO, when BHRT actually had a fairly a decent size staff- including regulatory affairs people, science staff, etc. and they still had a little bit of money left. The IPO was then in about Feb 2008 and then it was straight down from there and delisted from the NASDAQ almost 1 yr later to the day- and then the slide into pinks/OTC and penny-ville. Does one really think they're still retaining that entire "advisory board" today, as a sub 3 cents, 4 person penny stock? Really??
I just picked a random name off that list of "advisers" and Googled it. The BHRT web page says that Edward Diethrich, M.D., is at the "DIRECTOR at Arizona Heart Hospital Phoenix".
Well, CURRENT FACTS show a few problems with that OUT OF DATE INFORMATION.
Here is the UP TO DATE FACTS a simple Google search revealed:
http://www.bizjournals.com/phoenix/print-edition/2012/01/13/heavy-heart-noted-valley-surgeon.html?page=all
He's NOT THERE ANYMORE. UP TO DATE- not 2008. Edward Diethrich, M.D. LEFT the "Arizona Heart Hospital" a couple of YEARS AGO and is NOT it's "director" as the BHRT, 2008 data claims. See how easy that was?
Here's more:
http://www.medscape.com/viewarticle/726311
The "Arizona Heart Hospital" on the 2008 BHRT DATED INFO PAGE- went BANKRUPT, in 2010, FOUR YEARS AGO.
"as of 2008" means just that, it WAS, PAST TENSE, "current" over 6 years ago. That's what it means IMO, and it's not debatable. Simple Google searches will prove it.
In your opinion.
"As of January 1, 2008, Bioheart’s Scientific Advisory Board consists of the following members:"
TWO THOUSAND AND EIGHT. Just a "tad" out of date, no? I've looked every last one of um up- and I think I found ONE that still listed something about BHRT in his web page, if I could even find the person in a web search. Most I looked for aren't even at the same location or hold the same title as that 2008 "current" page.
"As of January 1, 2008, Bioheart’s Scientific Advisory Board consists of the following members:"
Well, checking a calendar, it's now AUGUST OF 2014. More than SIX YEARS from that list that's "current" as of Jan 2008. Doesn't amount to much IMHO.
Read the disclaimer too:
"Members of the Scientific Advisory Board may resign without notice at any time."
They were more than likely paid a fee to "appear" on that board IMO.
When one lists info as "current" and it's stamped 2008, well....
What does it say that they can't even update their own web pages beyond 2008 information? How many of those "advisers" does one really believe are still around and in some close contact or meeting regularly with BHRT ? Really?
Gamida- Look at the valuation they're (big pharma) is giving it, it's not some penny stock. That 15% stake is valuing the company at $250 million or so.
Look at their mgt team- it's top shelf, with actual backgrounds in successful drug development and approval in the past, past big pharma positions, etc. M.D.'s and Ph.D.'s with many of the who's who of big pharma company experience.
http://www.gamida-cell.com/team.asp
Look at the BOD- big time venture capital folks with long backgrounds in raising capital.
Look at the Gamida pipeline- it's broad and deep and they have a completed phase II/III trial- in a what, a "cord blood" methodology involving bone marrow, pretty much the only area the FDA has approved to date (Hemacord). It looks like Novartis is after this highly proprietary cord-blood technology to enhance potential other oncology related stuff that Novartis is building a portfolio of- an area they're looking to round out in their own pipeline/portfolio. Nothing about autologous stem cells in there that I can see? Gamida has a rich patent portfolio it looks like and a lot of original invention.
http://www.gamida-cell.com/products_pipeline.asp
Remember, BHRT does a lot of licensing of other people's tech, versus original research/invention IMO (other than probably their catheter stuff, which doesn't make much money) and most of their past patents have expired (read 10-K/10-Q filings). For instance, they lost the lipicell deal or whatever it was, so they had to go and do a new license "term sheet" now with another firm and just renamed it "Adipocell"- they didn't actually invent it, they just license someone else's stem cell "stuff".
Example: Page 5, Last 10-K filing-
"AdipoCell
Bioheart has successfully completed various trials using adipose stem cells. In August 2013, the Company canceled its license agreement with the Ageless Regenerative Institute for adipose derived stem cells called LipiCell. Bioheart has entered into a term sheet agreement with Invitrx to License their adipose derived stem cell products. Bioheart has changed its adipose derived stem cell product name to AdipoCell. "
Or page 16 same 10-K:
"MyoCell is no longer protected by patents outside, which means that competitors will be free to sell products that incorporate the same or similar technologies that are used in MyoCell without infringing our patent rights. As a result, MyoCell, if approved for use, may be vulnerable to competition. In addition, many of the patent and patent applications that have been licensed to us that pertain to our other product candidates do not cover certain countries within Europe."
Novartis taking an equity stake in this Gamida Cell is hardly comparable to BHRT IMO. What "equity" is there in BHRT to even take? They're diluted out to the max and yet have a total market cap of only about $14 million. What portion of that $14 million market cap and little equity is someone going to be willing to buy? Don't see it happening IMO. Apples to Kumquats IMO.
MM walks it back up 5% on a single, 2,250 share trade. Sells down on higher volume days (like yesterday), then they open it back up on much, much lower volumes, but real wide spreads. When it sold off on over 500K shares yesterday, the spread "normalized" to like .0270 bid and .0271 ask. You don't see that on these low vol days.
That appears to be the pattern IMO. One, single, 2,250 share trade posted and it was about 30 minutes ago (9:34 AM Eastern), and nothing since.
2,250 X .0275 = $62 bucks worth.
(bid .0263 and ask .0275)(high spread and bit at about 50 DMA)
Volume is really dried up on the days there's not more selling than buying it appears. Seems range locked and flat lining for long periods- sometimes one hour or more between trades.
When it's gotten in this low volume, high-spread "mode" in the past 3 or more months, it usually means one of those 20% or 30% or so big drop days is lurking out there IMO. All it takes is one sell order of decent size, someone just wanting to unload, and at these volumes the price just gets sunk- to the 200 DMA and even below, several times in the past 3 months or so. The 200 DMA is now at about .024.
Sold off right to the 50 DMA avg again- that seems to be the pattern of late.
Any "up" day has been on much lower vol and wider spreads (like 5% to 11% sometimes by the MM)- most "up" days recently being about $6K to maybe $12K traded the entire day (200K or so shares tops on several days) when the MM "walks it back up" using ultra wide spreads and gets it back near that .029 to .030 range.
Then the selling/sell-off days have been much higher volumes- in the past week the two selling days were about 850K+ shares and then a 1.2 million or so share day. Taking it right back to the .025 or .026 area of the 50 DMA. It's breached the 50 DMA and hit all the way to the 200 DMA several times on very high volumes in the past few months.
Seem like just too much dilution and low cost share overhang out there IMO, making it range bound, barring anything real unusual. Seems like maybe some "big boy" has some standing sell order to unload at anything in the .0275 to .03 range maybe. They (BHRT) had 10's and 10's of millions of shares go out at around 1 cent to 1.5 cents, so it could take a long time IMO to unwind selling all those, if someone is indeed selling. Lets say some large seller wants to get rid of 10 million shares they got at around 1 cent to 1.5 cents. They can almost double their money if they can sell anywhere in this .0275 to .03 area. Selling say 50K blocks a couple times a week to keep from burying the price, it can take many months IMO to unload all 10 million shares- just as a hypothetical example.
As an example: From the Q-1, 2014 10-Q here's 18 MILLION shares they, BHRT, issued to "someone"- at about 1 cent each.
Page 24:
In April 2014, the Company issued 18,383,774 shares of its common stock for service rendered valued at $180,511.
$180,511/18,383,774 = 9/10th of ONE CENT. So lets say that person/entity (we have no idea who it is, or what "services rendered" they provided IMO?) but lets say they are a seller now- they could be doubling that $180K, easily IMO. How long would it take for them to work through selling off 18 million shares? I'd think months probably, else they'd collapse the share price IMO.
Not sure what difference any "12 month results" make regarding a tiny, 5 person phase I trial done in Mexico? Lets suppose they are "good results", so then what? Look what happens to all their trials when they hit phase II/III? They stop, for "lack of funding", with the two most key trials being dead in the water for heading on 4 or 5 yrs now, gone nowhere and no "funding" having materialized. The MIRROR trial was much hyped over a yr ago now in PR as the "new" phase III, then just vanished for all intents and purposes IMO, then now re-appears in this latest 10-Q and is what, "waiting on funding", meaning it never really went anywhere IMO from reading the company documents. The PR on MIRROR hyped it as being "fully funded by Bioheart" (like who else is going to "fund it", since it's their trial?), and they blasted out PR they had "enrolled one patient" (and "randomized" that one patient- which made no sense to me?), and then silence for over a year now until this latest 10-Q.
http://www.marketwired.com/press-release/bioheart-announces-phase-iii-mirror-trial-for-myocell-initiated-otcqb-bhrt-1807938.htm
Here's where all the trials seem to sit when they hit phase II/III IMO, so I don't know what the "12 months results" will matter on anything for some tiny phase I?
Most recent 10-Q filing, Q-2 2014 PAGE 27:
"We are seeking to secure sufficient funds to reinitiate enrollment in the MARVEL and REGEN trials. If we successfully secure such funds, we intend to re-engage a contract research organization, or CRO, investigators and certain suppliers to advance such trials. We have initiated and enrolled our first patient in the MIRROR trial in 2013. The trial is very similar to the MARVEL trial but focusses on sites outside the US. We will continue enrollment in the MIRROR trial once we have secured sufficient funds."
That's it. the word MIRROR appears in that paragraph and in that 10-Q filing 2 times, and Marvel and Regen are siting right where they've been for yrs now. They couldn't even fund MIRROR "outside the U.S." as a phase III. So what difference does the latest phase I, tiny, 5 person trial, "12 month results" from Mexico really matter? Not getting it IMO?
Company info on I-Hub header may be out of date?
Not sure who/how that info above, all the stuff about the company gets updated- but I think at least some of the BOD/Officer's ages are out of date and I don't think that statement about "Richard T. Spencer resigned" and all needs to be there anymore- as that's quite dated IMO and Comella is now a permanent BOD members as far as I know from latest filings?
Here is from the last 10-K, Page 67:
Executive Officers and Directors
Set forth below is information regarding our executive officers and directors as of December 31, 2013
Mike Tomas
48
Director, President and Chief Executive Officer, Chief Financial Officer
William P. Murphy, Jr., M.D.
90
Director, Chairman of the Board
Mark P. Borman
59
Director
Charles A. Hart
53
Director
Sam Ahn
59
Director
Kristin Comella
37
Director, Chief Scientific Officer
Sheldon T. Anderson
63
Director
So, if that was as of Dec 31st, 2013 per the 10-K (8 months ago) and it has for example Tomas as being 48 yrs old, Murphy as being 90 yrs old, etc. And again, I don't know if they ever had an "annual meeting" but by all indications I think Comella is permanent on the BOD now, so the *"Richard Spencer" wording can probably be removed IMO. In that 2013 end of yr 10-K, they didn't even put Richard Spencer in the table of the Officers/BOD and no "*" notation about him was included. It straight up lists Comella as on the BOD now, no "*" or sub note.
I don't think the I-HUB header info quite matches. No major biggy items- but the closer it matches, it's just more accurate. Not sure who updates that?
"It is a biologic. Period "- I don't agree with that portion, given the CELTEX warning letter, which IMO is pretty clear, but it's OK if that's one's viewpoint. No sweat.
But the rest of the statement is finer- much clearer. So the key argument/theory is that via this "biologic" arm/division versus I guess a pure "drug" aka pharma for example, it's being argued that the trial enrollment will be less (less people, as in say 200 versus a theoretical 1000 or something for example) and thus "somewhat" perhaps less costly? Fine, that's a viewpoint and I can respect that.
I've seen however, major "drug/pharma" products (pick one- say an antidepressant or something), and if I remember correctly (I'll do some checking) I don't remember the trials (phase III) being 1000 people/enrollees or anything of that nature? In fact one of my own gripes for lack of better word with FDA approval of some of these, IMO controversial, "drugs", is that when one looks carefully at the trial(s) that got um approved, I'm often stunned how FEW people were in them (maybe 200 as a sample that's supposed to be statistically representative of an entire population- say 300 million people in the U.S.) and that they maybe at best, often lasted 6, maybe 8 weeks or something- which is a joke IMO, when trying to determine if some brain altering drug is "safe" or even what the heck it actually does, or what its long term side effects are even short term, let alone mid-term and long term, etc.
So, I'm not really familiar with this premise of a "drug" trial leading into the 1000 patients size and a "biologic" being much smaller and thus I guess "simpler" or at least less costly? I'll look into it more.
Bottom line to me, again, is phase III through the FDA, no matter how one wants to slice it- is a daunting, expensive (massively expensive IMO) and usually long, complicated and drawn out process and tough as all get out to get an approval. Given all the evidence of even mega big companies that get a large number of their products rejected every single yr by the FDA, I don't know how that can be disputed?
And I'm not saying I'm any huge fan of the FDA and a believer in exactly what they do and how they do it or if they're really even always serving the best interest of the public at large anymore. It's just that for now- they're the law of this land (Euro has a pretty similar law of their land) and thus anyone wanting to play in this arena of a biz undertaking pretty much lives and dies by the ole FDA. Sometimes sad, but true. They have the long arm of the Federal govt tied to um- so their enforcement powers and abilities don't get much more powerful IMO. Again, not even saying that's necessarily a good thing anymore, just the way it is.
That's all fine and dandy- I guess I'm not getting or missing this point of splitting hairs between the "biologics" dept. and the word "drug"?? Cause if one follows the links in the very email to the "approval process" - it leads right to a "new drug" application process as far as I can tell?
Further, the CELTEX warning letter, under the long arm of what I guess is the "biologics" dept., leads right to them labeling the company as trying to peddle/sell a "drug" and what the implications are behind that.
So, I guess I'm confused. My understanding, is your point is that flying under the banner of the "biologics" department will someone make a phase III for lack of a better word "easier" and also make the product approval process "easier" somehow and thus somehow cost less? That's where I guess the connection falls apart for me- as I'm just not seeing that part of the argument?
Again, the key link in that entire FDA response email to me- is that CELTEX warning letter and all that it states and implies- and it all leads to, IMO, the essence that they need to treat their product as a "drug" (via the biologics dept or whatever) and regulate it as a "drug" and get it properly approved as a "drug"- all via the "biologics" arm of the FDA? So how did that get CELTEX "off the hook" or on to some "easy street" road to an approval or whatever?
That's where I'm at? It all just leads back IMO, to a good ole "FDA APPROVAL" (phase I, II, III, approval submission, new "drug" application from those links it appears) which is costly, takes enormous amounts of time and paperwork and money- right back to where the trials are at right now, as far as I can tell? Is there something different in the story?
"You only bolded the word "drugs""
Read CELTEX FDA WARNING LETTER from link provided by the FDA in very email, FDA response in original post.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm323853.htm
It says it all IMO. It's pretty daunting IMO, in what it says actually- they, this CELTEX whoever they are (I have no clue on them- but will read up on um) are being warned of being "shut down" (exact words are " Such actions include seizure and/or injunction.") essentially for "handling" and "processing" and "storing" and "manipulating" stem cells at their facility and then "promoting" them to physicians.
That's the way I read that warning letter- it's quite a read IMO.
"Current medical practices are like Blockbuster and stem cells are like an emerging Netflix type practice that could render many businesses obsolete."
Don't dispute that at all- ANYTHING is possible in this world and with a new area of "potential" and "yet unproven" science. Question is- how much mulah-cash-money and how much time? BHRT is in a game of beat the clock right now IMO. They decided to go from the "clinical lab" stage where many of these potential products/ideas are still at (and where many of the experts working on them are still saying time frames of like 8 to 15 yrs out to a "product", if ever), but BHRT decided to move to the commercialization arena earlier on, believing they had the "goods", but that has yet to be proven, and in the mean time their money has largely run out IMO and they are not finding a "funder" yet for these old (4 to 5 yr old) trials now? Why is that? What does the investment community see in those trials that stopped um at the phase II/III transition- the "zone" where they're about to cost the most money - the ole final phase III arena? There were side effects and "other" issues as noted in the BHRT 10-K filings- maybe someone isn't ready to pony up money for that risk yet? Who knows? But no "funder" has come forward yet to advance these trials and the stock sank from $5 or so, to now sub 3 cents, while dilution has continued unabated at a furious rate. Why?
That's the $64,000 or million or billion dollar question IMO. Remember too- ole Netflix is on the verge of getting crushed like a bug on a windshield, the day Google or Apple or Comcast or Time Warner someone with that kind of horsepower decides the "Netflix model" is valuable enough and "works" and is a profit generator. Netflix has yet to put a cable company out of biz- not even close. Netflix' biggest problem is now everyone is putting the squeeze on to pay for good content- and guess who holds a lot of the control over content? The "big boys" -the same old club. The best Netflix can hope for then is to be bought out at a lucrative enough price- one never knows when the "Big boys" will buy you or crush you. Microsoft used to do a lot of "crushing", these days there seems to be more "buying" - but who knows?
Follow the CELTEX LINK and WARNING the FDA issued- as included in that email reply and read the FDA/warning ruling for "stem cells" that were more than "minimally manipulated"- ah, DRUG was the determination.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm323853.htm
"
You are promoting the CellTex product in a manner that causes the product to be a drug under section 201(g) of the FDC Act [21 U.S.C. 321(g)] and a biological product as defined in section 351(i) of the PHS Act [42 U.S.C. 262(i)]. Please be advised that in order to lawfully market such a biological drug product, a valid biologics license must be in effect [21 U.S.C. 355(a); 42 U.S.C. 262(a)]. Such licenses are issued only after a showing of safety and efficacy for the product’s intended use. While in the development stage, for example, while being studied in a clinical investigation, such products may be used in humans only if the sponsor has an investigational new drug (IND) application in effect as specified by FDA regulations [21 U.S.C. 355(i); 21 CFR Part 312]. The CellTex AdMSC product is not the subject of an approved biologics license application (BLA) nor is there an IND in effect. Based on this information, your product violates the FDC Act and the PHS Act. "
"Overall Response
Please provide details as to how you plan to deal with the biological drugs that have already been manufactured at your Sugarland, Texas facility in violation of the FDC Act and PHS Act. Additionally, we note that SOP’s and records collected during the inspection as well as translated copies provided in your correspondence appear to relate to your RNL Bio facility in Korea and not your Sugarland, Texas facility. In your response, please address the concerns that your AdMSC product is a drug as defined in section 321(g) of the FDC Act and biological product as defined in section 351(i) of the PHS Act. "
"Stem cells are approved through the BLA panel and are considered biologics"
That is NOT what their response says at all when one reads it in completeness?
The email "question" posed did not ask about a HEART STEM CELL "product" such as Myocell; this FDA answer could be referring to a "skin cream" for all one knows? Also, it doesn't answer a single thing in regards to how much a phase III trial costs or does not cost and/or how difficult and FDA approval is/is not to achieve as they HAVE NEVER APPROVED ANY "stem cell" ANYTHING yet to date, except for ONE, ONE product, "Hemacord". Also, read the recent court ruling regarding a stem cell "product"-
http://www.the-scientist.com/?articles.view/articleNo/39108/title/Judges-Side-with-FDA-on-Stem-Cells/
I'll write the FDA and specifically ask about the Baxter and BHRT phase II/III trials and ask how/what path those will follow in order to gain FDA approval, THAT is the question that needs to be asked. Not how are "stem cells" approved?
That's not what the response says. Not even close. That response is narrow, and specific and spells out a very limited sub set of what is being branded "stem cells", as if ALL "stem cell" anything meet that criteria. Ask in the email HOW MANY STEM CELL "products" and what are the PRODUCT NAMES that have been FDA "approved" under this particular code/section BY THE FDA TO DATE- ask them that.
a) NO "stem cell products" have been approved by the FDA yet other than ONE per their own web site, so how would they know what path a particular "stem cell product" approval would/will follow?
http://www.fda.gov/forconsumers/consumerupdates/ucm286155.htm
"FDA has approved only one stem cell product, Hemacord, a cord blood-derived product manufactured by the New York Blood Center and used for specified indications in patients with disorders affecting the body’s blood-forming system."
b) READ THE RESTRICTIVE DEFINITION- it appears that Myocell would already fall outside the criteria IMO:
"To satisfy these criteria, an HCT/P must be: No more than minimally manipulated (relates to the nature and degree of processing); intended for homologous use only (the product performs the same basic function in the donor as in the recipient); not combined with another article (with some limited exceptions); and the HCT/P does not have a systemic effect and is not dependent on the metabolic activity of living cells for its primary function, or if it does, the HCT/P is intended for autologous use or use by a first-or second-degree blood relative. "
"HCT/Ps that do not meet all of the criteria of 21 CFR Section 1271.10 are also regulated under Section 351 of the PHS Act and/or the Federal Food, Drug and Cosmetic Act as drugs, devices and/or biological products and would require pre- market approval . "
And there ya have it- the court case where "stem cells" were determined to be "highly manipulated" and thus were determined to be a "DRUG". The email didn't answer a thing as related to the scope/type of product BHRT is developing IMO. It's clear. This email for all one knows is referring to a topical skin cream or something, and uses a generic term "stem cells". Unless they, the FDA, specifically answer a question in regards to a current trial, such as listed on clinicaltrials.gov, then I don't think one can know how or what "channel" that particular product/process will follow to approval and this email pretty much says just that- it's a "case by case basis" and the scope is determined by numerous factors that can shift under various parts of the regulatory code. And again, the recent court case ruling is the most plain example of that very scenario- the guy/company was arguing that very narrow criteria spelled out above, the FDA said NO, you're outside that criteria and now you have a "DRUG" on your hands, and the appellate court just upheld that decision, IMO
http://www.the-scientist.com/?articles.view/articleNo/39108/title/Judges-Side-with-FDA-on-Stem-Cells/
And again, NOTHING in this scenario has any bearing on what a FDA phase III trial cost or does not cost and how difficult it is or is not to gain and FDA "approval" for a particular "stem cell" product.
http://www.nbcnews.com/id/36849354/ns/health-heart_health/t/sick-desperate-fueling-stem-cell-tourism/#.U-52ZcVjWQl
Written in 2010 and what did one of the world leading experts in the article, a leader in current stem cell research say:
"Researchers estimate the cost of a three-phase stem-cell trial will be upward of $50 million, with a 10-year time table. "
http://www.npr.org/2010/07/26/128696529/offshore-stem-cell-clinics-sell-hope-not-science
Simple.
Well I've seen that Baxter is "in play"- you've seen me post that they are running trials as indicated on clinicaltrials.gov. The issue there I see is they're the 10 million pound gorilla in the room- but look at their trial updates. They're indicating year(s) for even prelim results- and imagine the money and the size of the staff they can throw at it.
IMO, major pharma/med companies ALWAYS put "in play" a pipeline of any field that shows some "promise"- they have to, in case it breaks big or wide open. All tech is like that. Example: I'm familiar with hard disk tech (long story- details don't matter)- I know for a fact that the two, then largest disc makers in the world, Seagate and Western Digital were years ago- "dabbling" and making strategic investments in all kinds of "storage" technology; flash, crystal solid state, molecular level way out there stuff and they still are today. Why? Cause they know if one of these technologies hits and hits big- they need to be the "player" in it, or suddenly their disc biz is a dinosaur and they are lights out, out of business. This is why Google and Apple and others "buy" what they don't have as it emerges- they can't get left behind and be made obsolete.
So what do I see- I see Baxter for instance, "sprinkling" there R&D money around in fields that are "interesting" and may go "in play" someday, but are quite a ways and many dollars out probably in their view. That's the way I'd "call it" IMO.
Interesting that the the FDA letter though directs them to the "drug labeling" guidelines. It was pre this recent court decision- so don't know about that?
Also, I'd need to research what exactly the hemacord product/process is and do they remove it and "manipulate" the cells outside the body in the "lab" environment?
Will look into it more.
Also, again, why is only ONE PRODUCT with "stem cell" anything in it approved to date? And why are nearly all public traded companies that have "made a go at" becoming pure "stem cell" plays all ended up as penny stocks? It's a big number that have sunk to the pinks/OTC and also already gone BK/vanished. So far, it's a lot of capital poured out, but not a single, major "blockbuster" or even a moderately selling product that I'm aware of?
OK, got it. Meaning if a drug is needed on an on-going basis, you go back and buy it over and over again each month, probably for years.
And you're theorizing the "stem cell" (BHRT or whoever lets say, for whatever particular malady) to be a "cure", thus a one time payment is made, then the payments stop as patient is "cured".
OK. Fine- that's a theory. But isn't that what many surgical and other type procedures already do for certain ailments? A patient goes in, gets an operation, the situation heals, no on-going drug/pharma needed. That certainly hasn't put the pharma/drug biz out of business, not by any stretch- and a LOT of surgical procedures already approved and in existence today can "fix/cure" heart related issues, no? Putting a pig valve in for instance- lasts years, maybe the rest of a lifetime, as just one example. Or a stent, etc?
"no drug "come back " money"?
Not familiar with that term/phrasing?
What does it mean exactly? I'm assuming something in the big pharma ability to make long term drug profits or influence doctor's or something? Not clear?
"First of all the price has been holding between $.025 and $.03. Not $.01 " Never said the price is at .01. One CENT or there abouts is what those are providing cash/financing pay for their shares, they aren't paying market price, not by ant stretch IMO.
One needs to understand their "financing" deals via reading the 10-Q, and 10-K and similar. Those who are providing on-going (they do "financing" deals essentially every month, to two months)- and those doing those deals are getting their shares at about 1 CENT. Also, an enormous amount of warrants were handed out (50 million or something like that) that also have strike prices in the area of maybe 1.5 cents.
THAT is the 'financing" price that someone pays for BHRT share. NOT 10 cents or anything even remotely close to that.
Latest 10-Q, PAGE 14/15: ASHER, Daniel James,etc are getting 45% to 47% discounts on their shares. If they were to convert on a week when the price has been at about .025 recently, they be getting those shares for about 1.5 cents. THAT'S IT- the "going price".
Last qtr, they did deals when one does the math- where shares were issued as low as 9/10ths of one cent. NO ONE with "big money" is going to pay more than what some other person is being given shares at- in exchange for cash. NO ONE IMO.
Last 10-Q (Q-1) PAGE 17 as an example:
"On September 30, 2013, the Company issued an aggregate of 15,350,876 shares of its common stock in settlement of $175,000 of related party notes payable."
DO THE MATH: $175,000/15,350,876 = ONE CENT they just gave out those shares for. Someone got shares at ONCE CENT for an "note" they held.
WHO is going to "finance" for more than they're handing out shares to some person/entity for "note/loan" they paid back? WHO and WHY would they accept a lesser terms, worse deal?
No way IMO, and certainly not some outrageously high price like 10 cents? WHY? Why wouldn't they just pay 2.5 CENTS, the avg price over the past month or whatever? The 50 DMA?
"Biologics are approved through the BLA process ..." Well, TO DATE, there are NO "approved" so called "stem cell" anything except ONE, and it's related to cord blood. NONE have been "approved" - not one.
Why are nearly all public traded "stem cell" companies now penny stocks with out a SINGLE FDA approval to date? Why is that? There's a well known site that lists (he's attempt to find pretty much every public traded "stem cell" company) and that list is the who's who of PENNY STOCK land. Why? I don't know of a single other field in bio-tech, where essentially every company that has entered the field has sunk to the pinks and/or OTC market or gone BK, vanished, etc.
NO FDA "approved" products yet? Why?
I'd consider this cut n dry case- read the title:
"Judges Side with FDA on Stem Cells
A US federal appeals court maintains that stem cells proliferated in a lab must be regulated as a drug.
http://www.the-scientist.com/?articles.view/articleNo/39108/title/Judges-Side-with-FDA-on-Stem-Cells/
And THAT is EXACTLY what BHRT is doing. Removing the cells from the body and "manipulating/modifying" them in a "lab" environment, and then re-inserting them into the body.
Case closed, IMO. That court case and the FDA prevailed. The wording is clear. The defendant was trying to argue the very "biologics" exemption that keeps getting repeated, and they lost, and lost again on appeal. Simple as that IMO.
NOPE. Read the links, the FDA site and the VERY recent court decision. It does not get any clearer. I posted links to multiple, highly credible articles/sources. Unless there is a counter source of credible information to those- then they are "drugs" according to the FDA. It's well documented and now been tested in a court of appeal- and the FDA prevailed.
"With a $30million financing deal purchased at shares of $.1, that's 300 million shares "??
OK, so WHO is going to pay about TEN TIMES the "going rate" for BHRT shares right now? The going rate for recent BHRT "financing deals", ones as recent as the latest 10-Q, the 10-Q before that and the end of 2013 10-K filing, is about ONE CENT per share (Asher, Daniel James, 4th Man, warrant deals, etc). So WHO is going to pony-up some $30 MILLION big ones and pay approx. 10X what some other guy just paid for his shares?
To raise $30 MILLION at about 1 cent is going be more like 3 BILLION shares, not 300 million.
No way IMO some "big money" finance house/person is going to overpay more than the terms they're handing out to any other firm/finance person? Why? Who would do that and for what reason?
ALL stem cells are a "drug" at this point as far as the U.S. FDA is concerned. They stated it clearly and gone to the mat and to court on it and prevailed.
As far as they are concerned at this point, "stem cells" involved- then it's a "drug approval" and they've said it many times.
http://www.ipscell.com/2014/02/us-federal-appeals-court-sides-with-fda-propagated-stem-cells-are-a-drug/
http://www.fda.gov/forconsumers/consumerupdates/ucm286155.htm
http://gizmodo.com/5881492/according-to-the-fda-your-stem-cells-are-now-drugs
And there's lots and lots more- they are being viewed as "drugs" and thus face "drug" approvals, IMO.
$10-$15 million to complete a phase III trial? I would highly doubt that IMO- it's way, way, way low per any industry norms. That'd be nothing short of pulling a rabbit out of a miracle hat IMO to complete a high quality, FDA level phase III on that amount of money.
It's not uncommon to spend North of $100 million dollars to complete an actual phase III, FDA level/quality trial that'll pass muster of even making it to submission, let alone get reviewed, let alone make it through the gauntlet to FDA approval. $100 million is on the low side actually per industry norms. Reams of data out on the net about the extreme cost and time it takes to get a product candidate through a good, high level phase III and in front of an FDA review board. Phase III can take year(s) as in multiple years to complete- then they have to be written and compiled, the final documents are as thick as a phone book typically, then submitted and then may face numerous review questions- including asking for more trials/data to be conducted and repeated, etc. So even making it to a phase III completion, is far from a slam dunk that leads to an actual approved, salable product- not by a long shot IMO.
Just a few articles discussing the high cost of trials and how tough it is to make it through an FDA submission to an actual approval:
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.raps.org/focus-online/news/news-article-view/article/1359/report-phase-iii-clinical-trials-behind-increase-in-the-cost-of-pharmaceuticals.aspx
http://www.manhattan-institute.org/html/fda_05.htm
http://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/SummaryofNDAApprovalsReceipts1938tothepresent/default.htm
http://www.fiercebiotech.com/slideshows/fda-approvals-2012
Quote from last article:
"Deloitte said last year that the cost of developing a drug had climbed 23% to more than $1 billion, while the average number of late-stage compounds in development fell to 18 from 23. And some of the industry's most anticipated products proved this year to be big disappointments, from the hepatitis C drug Bristol-Myers Squibb ($BMY) scrapped after patients died during a trial, to the very recent failure of Merck's ($MRK) cholesterol fighter Tredaptive, the third blood-lipid remedy it abandoned last year."
That's just a few, there's books written about how difficult an FDA approval is and MASSIVELY costly and get more costly with each yr that passes. It's a daunting task and proposition to say the least. For every 1000 new, "potential" drug product candidates (compounds/molecules, interesting potential "drug" or whatever) a major pharma company introduces in it's initial lab R&D/pipeline or in some University R&D lab, I think I read where something like 2 or 3, maybe 4 are ever expected to have a hope of making it all the way from lab "studies" to probably "animal studies/trials" and then to human trials (phase I, II and then the might phase III hurdle) to eventually an FDA approval and seeing the light of day as a marketable product. The FDA approves like maybe 25 to 35 new drugs on a "good year", that's it. Of all the 100's of bio-techs and all the mega pharmas out there, it's about 25 or 30 approvals in a typical year. The stats are something like that if I remember correctly- daunting. That's why the major pharmas load up their pipelines so huge- they need, must have a "blockbuster" every 5 or 10 yrs or whatever and that "blockbuster" often carries the entire company for the next 5 or 10 yrs while it's under patent. The big pharmas have enormous war chests of cash and spend enormous amounts on R&D and "trials" and buy-out of other companies w/ late stage strong candidate products and all- as they must have a next "new thing" or they die out eventually.