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Almost 2 MILLION shares and it's in total free fall. Market cap now at a dismal $6.11 MILLION.
They have just short term debts like accounts payable and "other" that total more than $4 MILLION as of last 10-Q filed and total debt of more than $10 MILLION. Wow. They appear to be in real financial trouble here to me.
Notice lately, how the SELL OFF, MASS DUMP days have 3X or 4X or more the volume of the days where it sits, relatively flat, flat-lining, parked and maybe just slightly down?
This is what Magna "does" I think, from what I've read. It's how they "do what they do" IMO. Add in Asher, Fourth Man and Daniel James who all provided toxic, floorless, convertible debt deals- and it's just too many over-hang, no bottom shares and probably shoring going on to cause any retail buying to put any upward pressure on it IMO.
This is what toxic and never ending dilution looks like. It's textbook to me.
BHRT is gonna more than likely break 1 CENT to close out 2014, despite how many "PR's" and vast claims and "news" releases and paid-penny-promotion and talk of "revenues" and what not? Yet it's dropping like a lead boat anchor.
I wonder how much they're gonna spend in new legal fees now to defend this large case, the one seeking approx $2.3 MILLION in damages from BHRT who has about $250K (thousand dollars) total assets to their name, and little to no cash at any one time? And they now owe just 2 insiders $800K in cash bonuses for 2014 (see latest 10-Q filing), for producing a near record low stock price? Wonder, are those "performance" bonuses or what?
Look at this law suit they had to disclose in the Manga updated prospectus docs they had to file with the SEC. It can't be cheap IMO to hire all those law firms and lawyers- how is one dollar going to supposedly go to "fund trials", etc? That Magna line, given this share price now- won't even produce enough money to pay their salaries for the two insiders, plus their huge cash bonuses plus now what must be large legal fees, plus all their other overhead and over $2 MILLION in accounts payable and other bills they often pay using common stock for a whole wash-list of reasons such as "money owed related parties" or "consulting" or whatever.
From the recently filed, modified Magna prospectus, PAGE 75:
http://ih.advfn.com/p.php?pid=nmona&article=64900333
"Legal Proceedings
On November 10, 2014, the Company was served with a lawsuit by an alleged assignee and a guarantor to a Loan Guarantee, Payment and Security Agreement. These parties claim breach of that Agreement and damages of approximately $2.3 Million plus interest. The assignor and assignee also sued the Company’s directors and a past director and an affiliate shareholder for breach of fiduciary duty, claiming damages as alleged creditors arising out of these parties' alleged participation in Northstar Biotech Group, LLC, a secured creditor of the Company."
https://www.clerk-17th-flcourts.org/Clerkwebsite/BCCOC2/OdysseyPA/CaseSummary.aspx?CaseID=7862332&hidSearchType=party_case&DisplayCitation=no&CaseNumber=CACE14021256&SearchType=
One would assume that Bioheart the company is picking up the legal tab to pay the legal costs to defend all these insiders, plus the corporation itself? Can't be cheap IMO.
And that's the 2nd major lawsuit involving BHRT and its corporate officers and firms they've done business with or had "deals" with.
This is the other one. How much in legal bills can a cash poor, nano cap company afford before it really takes a major toll, I wonder?
https://www.clerk-17th-flcourts.org/Clerkwebsite/BCCOC2/OdysseyPA/CaseSummary.aspx?CaseID=7155410&hidSearchType=party_case&DisplayCitation=no&CaseNumber=CACE13024037&SearchType=
I mean is there gonna be cash left for anything like actual medical trials, or R&D (they spent almost nothing on R&D this yr, only spending about $3K a month, total for R&D last qtr, see SEC filing)- I mean what are they doing each day, day to day, I wonder as their actual "business" - if they have no trials being funded or conducted and essentially no R&D money being spent- and all funds for the most part going to stuff like large salaries for 2 people, plus large cash bonuses for the same 2 insiders plus all kinds of lawyers to defend the company and a hand full of insiders- it just seems hard to try and figure out, IMO, what actual "business" they are even in or actually "do" anymore?
"Share price weakness continues."
Real weak in here now IMO. No buying pressure at all it appears.
This may close out 2014 (their biggest yr in history, "I guess") may close it out in the $5's - looking real possible here. It's near the 52 week low after how much "news" and "PR" and all?
If this is the best it can do w/o the 30% pure dilution being shoveled into the market yet (not even priced yet, 10 million new shares that will enter the market essentially in a lump sum hit), then I'd say there's way more probability of more downside here than any upside.
Trying to time and catch falling knives can be dangerous. Sitting on dead money for a long, long time can be costly too. There's not only real losses to possibly incur but lost "opportunity costs" if that capital had been deployed elsewhere. One can always re-enter later at a lower point, post dilution, and post the present confusion and uncertainty, after the dust settles.
It's dropped more than 50% now in about a 2, 2.5 month time frame. That's some pretty serious potential losses along the way for some, perhaps.
My 2 cents.
WOW, there it goes !!! .011 new low bid. It's gonna break 1 CENT looks like.
NO bid support, none. It's been in and remains in total bid free-fall and a seemingly irreversible power down-trend.
It's past "weak" in here IMO. There appears to be no bottom and no buying pressure or interest whatsoever now. They've fired off numerous "PR" and "news" and what not and nothing has even budged it one iota up. Even a new paid-for-promote Youtube video was just recently posted and linked.
Perhaps it's just the massive, massive low priced share over-hang caused by all the convertible debt use and cheap shares given out? Magna and Asher and Forth Man and Daniel James?
Wow. Imagine now if they need to tap the Magna "credit line" (which they said they would, and planned to tap all of it)- with the price this low, the dilution is going to be that much more massive for even small amounts of survival cash.
Appears it's in the death spiral classic IMO. Lower lows and lower highs and no buying interest at all.
Wow.
"Here we go again ! TD Ameritrade: OCAT posted this morning as symbol not found.
What the heck!"
This apparently is all planned and linked to specially coordinated dates such as Jan 7th and Jan 12th of 2015 as reported many times by different "sources" here.
It apparently is all planned and designed to build massive shareholder confidence in preparation for a whole slew of "incredible" things that are probably, almost, likely, might be, about to possibly happen soon in 2015.
Apparently the NASDAQ and real successful companies like uncertainty and "blank" retail shareholder accounts and lack of ability to display accurate and timely price quotes and execute timely buy/sell orders in retail accounts, etc.
Just all part of some, apparently, immensely complex "plan". We just apparently don't "understand" it or see it all clearly yet IMO. Very confusing IMO, but apparently a "great plan" all playing out. Yes.
" No doubt in my mind that ACTC/OCAT has more value now then 2011"
Well, all except for the part that it doesn't have "more value".
The market cap today, as set and determined by the free market place, stands at $212 MILLION.
THAT is the "value" as being assigned by the market place. Not more and not less. It is what it is.
The market sets the price and "value" - it's not based on what it's "supposed to be" or "imagined to be". It simply is what it is.
Today it's $212 million as the stock opens, red, down at $6.17.
"Yes $OCAT Veterinarian revenues will be in the MEGA $millions and more than paying for all of the human clinical trials $OCAT has scheduled for 2015."
Wow, "mega millions"??? Is there a mathematical range defined by "MEGA $millions"?? I know of a lotto called the "Mega millions" but never have heard or seen the term "Mega $millions" used in business, mathematics, accounting or similar?
So, with this imaginary "MEGA $millions" on its way with apparently 100% imagined certainty- and a pre-known, imaginary date of within the calendar yr of 2015, it appears that OCAT Sr. Mgt has somehow not been told about, nor do they know about this incredible miracle of these "MEGA $millions" (however much that imaginary, 100% made up number is)- apparently they don't know about his pile of imaginary money arriving in 2015??
Because OCAT Sr Mgt just recently filed with the SEC a $100 MILLION (that's a real, defined number) they filed a $100 MILLION shelf offering on a 100% legal and binding document and said they likely intend to tap/use the entire amount as they'll NEED IT to fund "the beginnings" of advancing their trials and business needs in 2015? Why? Why would they do that when this "MEGA $millions" is apparently already proven and on its way? That's real strange IMO? I just don't get it?
In fact, OCAT Sr. Mgt who actually run the business as insiders (as opposed to just make up commentary about it) - they've made it pretty abundantly clear in their SEC and public commentary that the $100 MILLION shelf they filed (which means pure DILUTION selling of common stock shares) - they've made it pretty clear they more than likely will need MORE MONEY THAN THAT and that it's a very likely possibility they will file ANOTHER SHELF OFFERING later when the entire $100 MILLION first shelf gets all used and consumed via funding very expensive trials, plus just their overhead which presently is running about $2 million plus a month- the bare minimum they spend to stay staffed at current levels, turn the lights on, pay legal and insurance and all their other fixed costs and common overhead of running a small company.
I guess someone needs to give them, OCAT Sr. Mgt a major "heads up" that they are about to get an imaginary arrival of "MEGA $millions" apparently deposited into their bank accounts at some 100% certain point in 2015. This is big "news" (or just pure, imaginary speculation) - and they really need to know about it IMHO. WOW !!
"Jan 12, 2015 Timing is such that $OCAT will be on the Nasdaq and "quiet period" will be concluded for the 10 mil sh placement "???
Huh? What?
There is not a mythological "quiet period"? Where? What SEC filing or other document states that? The prelim prospectus is filed and thus that secondary offer can be priced and sold and closed at any time. There is no restrictions written in that document regarding some supposed "quiet period" delay? Where? Give the exact page number? The INSTANT that secondary would price and place- they, OCAT are legal bound to update that SEC filing in near real time as a "material event". That ""preliminary" prospectus would become finalized and the FIRST PEOPLE and PLACE TO KNOW would be the SEC and the public SEC EDGAR database where that finalized, priced and 100% filled-in document would then be uploaded, in near real time to the event occurring.
Similar, there is no proof or "magic date" regarding a uplist to the NASDAQ? Where, where is that stated? Presently, w/o the secondary occurring, OCAT doesn't even meet the minimum shareholder equity requirement of $4 MILLION and that's been explained using accounting 101, and using their own SEC filings to prove that w/o ability to rebut that point. It's 100% FACT. They have $723K shareholder equity- not even close to the $4 MILLION minimum.
Further, the company filed an 8-K "update" and did not list a single, specific date and certainly not Jan 12th, 2015 as some supposed "magic" date. They stated Q-1, 2015. Q-1 will encompass any date from Jan 1 2015 to March 31st 2015.
Again, point to any specific line in ANY SEC filing about a supposed "quiet" period and any specific reference to the date of Jan 12th, 2015?
Simply not true and just a WAG at best and total, pure speculation based on nothing of fact.
"Wopsal101 That is 100% correct." NO.
"The placement was made on Dec 12, 2014. " NO again.
There is nothing "correct" in that statement? There was no placement made on Dec 12, 2014?
What does that even mean? Where is there a SEC filing, public statement or anything else to that effect? Proof?
RIGHT NOW, this moment- there is an UNPRICED, UNPLACED, INCOMPLETE "preliminary" prospectus parked on the SEC EDGAR database. It is BLANK in every key field- because NOTHING HAS BEEN "placed" or priced or sold or completed yet regarding the secondary.
If the secondary was "placed" then that SEC filing document would be updated in near real time. PERIOD. Where is the proof that it was "placed" on Dec 12th, 2014? What does to be "placed" even mean?
http://www.sec.gov/Archives/edgar/data/1140098/000104746914009660/a2222363z424b5.htm
PRELIMINARY. PERIOD, end of story. And the company filed an 8-K update, saying everything regarding the secondary is now pushed into Q-1, 2015 (Jan 1 to March 31st 2015) and nothing further will happen in 2014. NOTHING has been "placed" in 2014.
"$OCAT PPS Sep 10, 2014 was $12.05 to $12.73"??? So what?
What does the price on Sept 10th have to do with anything?
The share price on FRIDAY, DEC 26th was $6.25. THAT is the market price, the most current price. If the offer were to price tomorrow, the MARKET PRICE, thee most current price they'd use is $6.25 a share. PERIOD.
Assets are NOT = shareholder or stock holder equity. NOT how it works.
Again, it's accounting 101.
Shareholder equity = Assets - LIABILITIES
From the recently filed prospectus, which takes all it's financial tabular data from all the prior 10-Q and 10-K filings:
http://www.sec.gov/Archives/edgar/data/1140098/000104746914009660/a2222363z424b5.htm
PAGE S-!5: (Year 2014) (It's called a BALANCE SHEET)
Cash and cash equivalents $7,812,497
Current assets 8,352,711
Total assets 9,247,699
Current liabilities 6,664,602
Total non-current liabilities 1,860,087
Total liabilities 8,524,689
Total stockholders' equity (deficit) 723,010
END OF STORY. $723K total shareholder equity. NOT meeting the $4 MILLION minimum for the NASDAQ lowest tier.
CORRECTION to that last line, it's $4 MILLION shareholder equity for the lowest tier NASDAQ, not $5 MILLION.
https://listingcenter.nasdaqomx.com/assets/initialguide.pdf
Stockholders’ Equity $5 million $4 million $4 million
PAGE 9, NASDAQ LISTING REQUIREMENTS.
OCAT is thus $4,000,000 - $723,000 = $3,277,000 SHORT.
They DO NOT presently meet the shareholder equity requirements for the lowest tier. PERIOD. END OF STORY. $3.2 MILLION shy, probably a bit more due to recent cash consumption for daily operations.
"and should be approx $7 to $8 PPS with current planned new shares issued of 10 mil + 1.5 mil new shs!"????
What? Huh?
The PRESENT PRICE, as of FRIDAY Dec 26th IS $6.25. There's no such thing as "the price SHOULD BE"????
The price IS what it IS. PERIOD. And the market today says the price is $6.25 and not one cent more. Any 10 MILLION SHARE, 30% dilution then takes place from TODAY'S market price, or whatever the market price is on the day they sell those 10 million shares. There's no such thing as "make up the price one wishes or thinks it "should" be"??
It will dilute from the market price and also be DISCOUNTED from the market price. As of last trade- that price was and is $6.25. Not $7 and NOT $8 and not $12, not even close.
This is markets 101. Basics. Fundamentals.
The underwriter(s) are NEVER, EVER going to pay above what the stock is selling for on the open market. Never. Today, that market price is $6.25 a share and that has been the price range for weeks now. Which means it's highly, highly likely they, the underwriters, will pay well below that price of $6.25. And NO, the 30% dilution is not accounted for yet- as not one single share of those 10 MILLION shares has hit the market yet as free trading, pure, 100% grade-A dilution shares.
Again, markets and basic finance 101.
I'm not misinformed about a thing. It's NOT $5 million cash on hand. Sorry. WRONG.
It's $5 MILLION in positive shareholder equity, not cash on hand. There's a big difference. It's accounting 101.
Shareholder equity = assets - liabilities. It's the first and most basic accounting equation taught to any business manager, MBA intro accounting class or similar.
From the OCAT recent prospectus filing, PAGE S-14:
Yr 2014:
Total stockholders' equity (deficit) $723,010
They are thus $5,000,000 - $723,010 = $4,276,990
$4.2 million dollars SHY, SHORT of the stockholder's equity requirement for a NASDAQ, lowest tier requirement.
Basic. They, OCAT, are presently about $4.2 MILLION short in shareholder equity. Reality, it's probably even a bit more than that as their cash position would have been depleted somewhat by now just to pay day to day bills and obligations.
"I think there is indeed a bidding war going on and that we will get a very fair pricing."??
Not a chance IMO. Who would be the "bidders" in this mysterious "bidding war"?? The underwriters are who buy the shares and they've already been signed and the prospectus filed and the deal inked, just awaiting pricing and the close.
A company or underwriting firm would never, ever, ever IMO delay or walk from a deal for the cause of having too much money on the table. Never. They strike while the iron is hot- it's their life blood.
1) The underwriter gets paid their spread, fees and commissions the faster they price and close and sell the deal. Those guys live and die by commissions and fees and want that money banked ASAP. They never consider it a "problem" from having too much demand, that's what they pray for on every deal. That's a problem they can always solve and solve quickly.
2) OCAT, the company, desperately needs this money to move forward. If there was high demand, you never delay and risk the deal going "cold" for any of 1000 different reasons. You grab that money and bank it and run as fast as one can. You could wake up the next day to find "news" of some IMF bank failing in outer timbuk-2 and find the markets just dropped 500 points in a blink and suddenly your deal just got sent to the holding tank. They'd never balk or hold or wait on a "good" deal, a high demand, strong priced deal via some mystery "bidding war", not IMO. They'd take the money and run, bank it while it's hot. Not sit into the new year with war and political uncertainty and who knows what else lurking out there that can trip up the markets and send every secondary and IPO deal on the table into the cold-case file indefinitely.
The only reason they hold and delay deals (secondary placements) in my book is because of lack of demand and lack of pricing power and needing to re-calibrate and lower their expectations because the underwriters gave um the reality of what the deal is pricing at. I think OCAT then balked last minute and set off the massive chain of sanfus causing the we uplisted-didn't-really-uplist mess on Friday Dec 18th that still isn't fully corrected even as of last Friday. FINRA then had to step in and play oversight- causing OCAT to show up on FINRA's daily report as "re-instated" to OTC. They caused chaos in people's retail accounts via shutting them out from accurate and timely quotes and even the ability to execute trades properly, etc.
What company would want that royal mess hanging over their heads, right as they're about to "try" and gain credibility and trust and pitch a deal to NASDAQ level hedge funds and other buyers? They just painted themselves as about as OTC, amateur as one can get. You couldn't screw the pooch at a worse possible time. A royal dropping of the proverbial ball just happened IMO. NO WAY that all happened cause they had too much demand or some imaginary "bidding war", not a chance in heck IMO. Something went amiss and went amiss bad. They then had to file the 8-K disclosure as "clean up"- essentially saying everything is "on hold" or at least delayed to 2015, have a Merry Christmas and Happy New Year, we'll see all of you in 2015 basically.
That's my take on what happened. Again, no way in this world, when markets can turn on a dime did they pass on a deal and good money because of "too much demand" or whatever was there. They only held because they couldn't get the demand they thought and it scared um off.
The stock traded as low as into the $5's, and it's parked at about $6.25 as of Friday. Those underwriters are always going to get a discount to that retail pricing- and on a more riskier OTC stock with a weak set of financials and a pretty tainted past- they'll need a steeper discount as they're not gonna get stuck with a bag of 10 MILLION shares they can't flip trade fast and for a good profit. That to me means they price somewhere like $4.50 to $5.00 a share probably. Tops. That's the reality of what I see happening. A 10% discount is not unusual for even financially strong stocks- and that would be $6.25 X .9 = $5.60 right there. I think OCAT is looking at a 15% or more share discount as they're very high risk. That puts it down near $5 a share tops IMO.
They can't uplist until they price and place this deal as they don't have the shareholder equity they need. Else, they maybe balked on the secondary and perhaps are going to try and tap Lincoln for a very large draw to make their shareholder equity, then uplist, then try the secondary again later, once they are on the NASDAQ. Thus the 8-K verbiage of "we're in dialogue" with the NASDAQ and pushing out to Q-1, 2015 which is any date from Jan 1 to March 31st, 2015.
Either way one slices it- they sure didn't build any confidence or earn any points for professional execution in my book after the Dec 18th fiasco and the subsequent week of mass confusion. Markets hate doubt and uncertainty - and they just served it up by the bucket full.
"I'll take a doctor's word that it is like a transplant. Super Post!"
I'll take the word of the COMPANY'S OWN SEC FILINGS and CLINICAL TRIALS info on the U.S. govt. website clinicaltrials.gov.
Is there a medical license number for this "doctor" one can look up and verify? Where is this "doctor" licensed to practice? Thanks in advance- look forward to learning more about the supposed "doctor". Very interested as I did not see any medical credentials or claim of a medical license stated anywhere, so how can one possibly know this or make this claim?
"OCAT is not a Drug or Stem Cell " FALSE. 100% NOT TRUE.
From the OCATA/ACTC last 10-Q filing with the SEC:
http://www.sec.gov/Archives/edgar/data/1140098/000101968714004157/actc_10q-093014.htm
PAGE 7:
" The Company’s intellectual property portfolio includes pluripotent human embryonic stem cell, or hESC; induced pluripotent stem cell, or iPSC, platforms; and other cell therapy research programs. The corporate headquarters and principal laboratory and manufacturing facilities are located in Marlborough, Massachusetts."
From the same SEC 10-Q filing, PAGE 27:
"This data, along with safety data we collected on the human RPE cells, or our RPE Program, formed the basis of several Investigational New Drug, or IND, applications filed with the U.S. Food and Drug Administration, or FDA, and an Investigational Medicinal Product Dossier, or IMPD, relied upon by the U.K. Medicines and Healthcare Products Regulatory Agency. It also served as the basis of our clinical trials using RPE cells in patients with SMD and dry AMD"
From same 10-Q filing, PAGE 28:
"Our program related to RPE cell therapy for the treatment of SMD has been granted Orphan Drug status in both the U.S. and Europe, which could accordingly lead to provide regulatory market exclusivity and potential FDA grant opportunities."
DRUG, DRUG, DRUG, DRUG- the word is PLASTERED throughout their SEC filings. It's a DRUG, CRYSTAL CLEAR. GLARINGLY CLEAR.
From the CLINICALTRIALS.gov web site for the OCATA trials:
https://clinicaltrials.gov/ct2/show/NCT01344993?term=rpe+advanced+cell+technology&rank=1
Verified April 2014 by Advanced Cell Technology
Sponsor:
Advanced Cell Technology
Information provided by (Responsible Party):
Advanced Cell Technology
ClinicalTrials.gov Identifier:
NCT01344993
QUOTE:
"Safety and Tolerability of Sub-retinal Transplantation of hESC Derived RPE (MA09-hRPE) Cells in Patients With Advanced Dry Age Related Macular Degeneration (Dry AMD)"
And QUOTING:
" Purpose
This is a safety and tolerability trial to evaluate the effect of subretinal injection of human embryonic stem cell derived retinal pigment epithelium cells in patients with dry Age Related Macular Degeneration (AMD) and to perform exploratory evaluation of potential efficacy endpoints to be used in future studies retinal pigment epithelium (RPE)"
From the FDA case law regarding use of STEM CELLS that are MODIFIED OUTSIDE THE BODY and then re-introduced into the body- they are REGULATED AS A "DRUG". A DRUG and a DRUG.
http://www.the-scientist.com/?articles.view/articleNo/39108/title/Judges-Side-with-FDA-on-Stem-Cells/
"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.
By Kerry Grens | February 6, 2014"
"The D.C. Circuit Court of Appeals ruled this week (February 4) that culturing a patient’s stem cells for therapeutic use falls under the aegis of the US Food and Drug Administration (FDA). FDA has said therapeutic stem cells should be regulated as drugs."
"
http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194655.htm
http://www.nature.com/news/fda-s-claims-over-stem-cells-upheld-1.11082
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"
"Consumers need to be aware that at present—other than cord blood for certain specified indications—there are no approved stem cell products." "
WHY is OCAT seeking $60 MILLION to $100 MILLION dollars to seek FDA approval? For what, if it's not for a DRUG product? Why? Why does their own clinical trial filing with the U.S. govt. use the specific words STEM CELL DERIVED? Why? What would they even need phase 2 and phase 3 trials for? Why? Just INJECT AWAY if this is the equivalent of some skin cream or eye drops like Visine or something, but of course it's not- it's a complex medical procedure using what is a DRUG according to the FDA and thus is highly regulated which is obviously why they're going to spend $100 MILLION plus dollars to seek an FDA approval.
Go to the sources for correct information. SEC filings, govt. web sites only.
"A positive financing package "??
Is that the opposite of a steeply discounted, highly diluted "financing package" - the type they are seeking now?
What's the exact definition of a "positive financing package" versus say a "negative financing package"??
Also, who exactly is "shorty" who's supposedly going to "be screwed"??
This is an OTC traded stock. There is little to no open short interest. The only people in general who can, and do short OTC stocks are professional traders, the market makers, insiders, the underwriters they just hired (see the prospectus), etc.
There is virtually ZERO retail shorting of this stock. Call up any retail brokerage house in the country and ask to get a retail margin account and short inventory on OCAT. Not going to happen.
So who is this mythological "shorty" person/entity about to "get screwed" and all? How is that gonna happen exactly? They just fired off every major "news" and "PR" announcement in their supposed biggest year ever- and the stock has gone nowhere.
In fact it's down over 50% in about a 2 month period, after a key insider dumped and unloaded a boat load above $12 a share, showing their long term confidence in what they think the stock is worth. There's been no large buying pressure or mass rush to get into this stock? Even the big "it uplisted-didn't-really-uplist" day didn't cause any mass buying to occur.
Not seeing what catalyst is going to "screw" this imaginary person/entity called "shorty"? Makes no sense IMO.
"How Come Gary Rabin is not in Jail"?
Well, the BOD approved every last share grant he ever got, approved of every compensation package he ever received and had to know of every share sale he ever made. The BOD and the Chairman of the Board are 100% responsible for oversight of any public company CEO.
The Chairman and the BOD are the TOP of the food chain
The CEO is then given direction and directive to run the day to day biz operations of the company.
The Sr. Mgt team then reports to the CEO, who in turn reports to the BOD.
That's the way it works in the big leagues. Langer as one example, was on the BOD since I believe 2011, so everything Gary did in that wash-list of share sales would have been on Langer's watch and that of the present Chairman Michael Heffernan, who was appointed chairman in mid 2012.
Got a "loose" BOD, you get a loose run company, IMO. ACTC/OCAT has a long, long, long reputation of taking very good care of their own and lavishly self enriching the insiders, as the common share holders have received a negative, zero ROI. (the common shares to date have lost 99% of their value, as insiders have been richly rewarded, and it's not just Gary that got heaps of easy money, large option grants to dump, perks and bonuses and all the rest) Nothing new here IMO.
Wanna blame someone- blame the BOD, it's their responsibility to "manage" the CEO. Simple as that. The BOD is also who approves pay and compensation packages for the CEO. So a beef about Gary's shares, all obtained via options grants, again leads straight back to the BOD.
Not that complicated.
"has pretty much achieved that already.."
No. A sample size of 18 (when looking at any population based study, regarding pretty much anything, let alone a highly invasive drug therapy) is not large enough, nor long term enough, to conclusively prove anything with certainty. There's a reason that phase II and then phase III grow proportionally much, much larger and enormously more expensive and include placebo and blinding, etc.
Then their is follow-on, follow-up safety studies and tracking, etc.
Not even close to "proving" anything conclusively yet- not via a tiny, tiny phase I. That's the first baby step on a 100 mile long road.
"This will sail through the FDA procedures,
because it's not a drug. "
"THIS IS NOT A DRUG.
THIS IS TISSUE REPLACEMENT. " ???? What? NO. Not even close. What facts is this assertion based on? Where is this disclosed in OCAT SEC filings or similar?
Again, NO. It's VERY MUCH A DRUG according to the U.S. FDA and according to the FDA "DRUG" trial(s) approval and submission path that OCAT is pursuing. WHY would OCAT be out trying to raise $60 million to $100 MILLION dollars in pure, Grade-A DILUTION money to run FDA TRIALS, seeking FDA APPROVAL is this was "imaginary" gonna just "fly through" cause it's supposedly "not a drug" and practically like putting a band-aid on one's finger?? Makes ZERO sense.
There has even been several Federal court cases now and the FDA has prevailed each time, that STEM CELLS ARE DRUGS and to be regulated AS DRUGS.
From the FDA WARNING TO CONSUMERS regarding stem cells:
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"
"Consumers need to be aware that at present—other than cord blood for certain specified indications—there are no approved stem cell products."
http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194655.htm
http://www.nature.com/news/fda-s-claims-over-stem-cells-upheld-1.11082
"FDA’s claims over stem cells upheld
Drug watchdog wins right to regulate controversial therapies."
" The US District Court in Washington DC affirmed the right of the Food and Drug Administration (FDA) to regulate therapies made from a patient’s own processed stem cells. The case hinged on whether the court agreed with the FDA that such stem cells are drugs."
http://www.the-scientist.com/?articles.view/articleNo/39108/title/Judges-Side-with-FDA-on-Stem-Cells/
"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.
By Kerry Grens | February 6, 2014"
"The D.C. Circuit Court of Appeals ruled this week (February 4) that culturing a patient’s stem cells for therapeutic use falls under the aegis of the US Food and Drug Administration (FDA). FDA has said therapeutic stem cells should be regulated as drugs."
It's CRYSTAL CLEAR that OCAT's "product(s)" that DO NOT YET EXIST and are not YET COMMERCIALIZED, "IF" they ever do come to market- are going to be 100% regulated as "drugs". Simple as that.
OCAT isn't "sailing through" anything. They've been at this 20 (TWENTY) yrs now and just completed a tiny, tiny phase I trial. Per their own statements- they have at least 5 more yrs and $100 of millions of dollars needed for a "chance" at a commercial, FDA approved, salable, commercialized, proven safe w/ proven efficacy for use in humans, product/therapy.
Just another typical BHRT PR that never materialized and was never heard about again. Do a search in their 10-Q filings for "Stem MD". If it's not in there, then it's amounted to nothing and will never be heard about again, IMO. That's how many, many BHRT PR end up.
The PR was in typical, vague BHRT fashion with vague terms used like "an agreement" and a "term sheet" blah, blah, blah. NEVER HEARD ABOUT AGAIN. What a surprise. That was in Dec 2, 2013 over a yr ago now.
Again, I'd expect it to never be mentioned or heard about again IMO.
http://www.bioheartinc.com/assets/press/2StemMD-final.pdf
", announced that it has entered into an agreement with StemMD. According
to the agreement term sheet, StemMD will provide Bioheart therapies to its global
network of physicians and qualified patients. "
Always VAGUE, not details, nothing monetary mentioned, no terms of revenue or how it would be monetized- just a PR hype IMO. Never amounts to anything. Never shows up later in SEC filings. Typical IMO.
How many "term sheet" PR's have they done that never amounted to a hill of beans? Remember the Vitalmex, $2 million "financing TERM SHEET"? Lots of ole "term sheets" over the years- that never go beyond a "term sheet". Funny how that always seems to "work out" that way?
"Actually, they'll "lend their names out to ANYONE"
It's really not even a matter of "lending their names" - as that is not the business they're in. They are an investment bank and buy the shares in the secondary FOR A DISCOUNT and then turn around and sell them. In turn, the company, OCAT, gets cash for their shares in a single lump sum, the underwriters makes the "spread" on the share discount, plus fees, plus expenses. That's the "deal" in a nut shell. It's not complicated. Underwriters are about making MONEY, LOTS OF MONEY. PERIOD.
They don't care a wit about the company they underwrite- other than, can they sell and flip the deal for a large enough profit for the amount of risk they take. That is their business model. PERIOD.
They are middle-man, money lenders and sales houses. End of story. All they want to know, if they buy OCAT shares, is can they unload them at enough of a profit to meet their internal guidelines and profit targets.
That is why on a riskier, cash poor, tainted past, no cash flow, no earnings OTC stock like OCAT, they, the underwriters, demand a steeper share discount and larger up-front fees and expenses. HIGHER RISK = HIGHER COSTS from the underwriter.
They're not "lending their name" to anything. They buy the shares, sell the deal, flip um as fast as they can, make a market in the stock, short it or whatever, make their money and move on. It's not a love affair; it's just cold, hard, brutal, pure for profit business as done on Wall Street.
Bid .0117 FREE FALL, new 9 month low bid just made.
No bid support whatsoever it appears. It's on higher vol today too- as it's been on every day of the past month or so that's it's making a new, lower bid (since the Magna deals were announced)
And the Magna, serious dilution hasn't even gotten started IMO.
No "news", no "PR", no Magna "credit line", nothing has been able to put even a slight bump in this strong, now 3 month plus down trend. I don't see any sign of a near term bottom yet.
Lower lows and lower highs and little to no buying interest it appears, despite the price continually dropping.
Looking real, real weak in here- both technically trading and from a financial strength stand point for the company. The market cap is now dismal at under $7 million, when stacked against their $10 plus million debts and just short term obligations of accounts payable and similar short-term expenses that total well over $2 million and almost no cash at any given time, $46K total cash close of last qtr (and $800K in "bonuses now owed to just 2 employees, see last 10-Q filing).'
The lower this price goes, the worse and more harsh the convertible debt and Magna "credit line" dilution gets. It takes more shares for the same amount of cash, the lower this price keeps dropping.
Weak.
HIGH_RESOLUTION_REALITY of the extreme COSTS and DIFFICULTY to reach a FDA phase III completion, let alone an approval.
http://www.manhattan-institute.org/html/fda_05.htm
Manhattan Institute- highly credible, respected research firm. Not some penny stock "review" newsletter or something.
"Part 1: Phase III Trials Are driving Rising Costs in Medical Innovation
In 1975, the pharmaceuticals industry spent the equivalent of $100 million in today’s dollars for research and development of the average drug approved by the U.S. Food and Drug Administration, according to the Tufts Center for the Study of Drug Development. By 1987, that figure had tripled, to $300 million. By 2005, this figure had more than quadrupled, to $1.3 billion"
http://www.fiercebiotech.com/topics/fda_approval_process.asp
"In order for pharmaceutical and biotech companies to market their drugs and biologics, companies must receive FDA approval, a rigorous, expensive, and time consuming process that can take over a decade to complete. Of 5000 compounds discovered in the pre-clinical stage, only about 5 will make it through the entire FDA approval process. Therefore, companies have to cover not only the cost of successful development of a single drug, but of many drugs that never make it to market."
FORBES, one of the most credible, biz journalistic sources still in existence:
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/
"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.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/SummaryofNDAApprovalsReceipts1938tothepresent/default.htm
What does a phase III FDA submission look like? Think it's a few forms being filled out and a little ole power point presentation being tossed in with some nice color slides attached to it?
A phase III FDA submission is typically 1000's of pages, even 10 THOUSAND pages of documentation- it's a mind boggling undertaking. There are entire contract firms, or in big pharma, entire dedicated departments with 100 or more people in them, all degreed specialists (from Ph.d's to M.D.'s to Masters in pharma and chem and science and engineering and bio-med and similar fields and full time tech writers, etc) doing nothing but FDA submission and regulatory affairs who may work a yr or more as a focused team just to write and draft the submission package. They then must do a long series of back-n-forth question and answer formal question/answer submissions and all done per very specific protocols, in reply to anything the FDA wants to ask or know or have clarified. DAUNTING, complex and labor intensive and time consuming and MEGA EXPENSIVE.
The photo is from the FDA site itself, in the link above. Think this is a "slam dunk" and "done deal" cause they completed a tiny phase I and put some cool looking color slides together in a 20 page presentation or whatever??
Photo title: Chemist Lee Geismer looking over an NDA at FDA in the 1960s.
That was in the 1960's, the "good ole days". It's only gotten more complex, more daunting and requires more paperwork today, with far less drugs than ever, as a percentage of submissions, being granted approval, despite record number of drugs starting out in the labs and phase I research.
Hopalong its your turn ...
If it's from icell- it's a 100% made up fantasy "story" with zero proof behind it IMO. Not even debatable as far as I'm concerned. icell = "wrong" and "more wrong" information. That's their only two categories as far as I'm concerned. What does it amount to to me? Nothing, that's what. icells "prediction" record at being correct is so low IMO, it doesn't even rate. Throwing darts at random choices gets better results.
Guess what, I talked to "some guy" who knew another "guy" once on Wall Street who via a friend of a friend they used to know, really knew this person who is a supposed real pro, who used to do IPO's (rumor is some of the biggest deals in IPO history they say) and all- and this person said the EXACT OPPOSITE of everything stated in the fictional icell tall tale.
Oh, and the dude I spoke with- it was one day ago, meaning it was more current than the 2 day old, imaginary icell info. I trust my guy more. More up to date info is better. Oh, and my un-named guy's conversation, it took at least 45 minutes, which is way longer than the 30 minute imaginary icell conversation. See, my guy's conversation was just so much better, all the way around. Way better.
That was easy.
"they don't lend their names out to just anyone! "
Actually, they'll "lend their names out to ANYONE" willing to PAY THEIR FEES and EXPENSES and SHARE DISCOUNT RATE.
That's their one and only criteria. It's Wall Street, the ONLY thing that "talks" is money, and lots of it.
"OCAT "Therapeutics" board-member Robert Langer "
Wiki?
Well, he jointed the ACTC (OCAT) board in 2011, brought on by CEO Gary Rabin (That's Rabin of SEC violation and conviction fame).
Apparently the BOD was not "hands on" or monitoring the company activities and day to day business close enough IMO, to keep their CEO from committing SEC violations, leading to SEC prosecution, fines, the exit of the CEO, etc?
What was the stock price and company value in 2011 when Langer got a BOD seat and what's it at today? Looks like while he was a BOD member, the stock diluted out to past 3 BILLION shares, was a solid OTC penny stock and sold for at least as low as 5 cents a share. Not bad I guess?
Normally, BOD positions are essentially just paid spots, handsomely paid to lend their name and potential connections to a BOD, show up and meet a few times a yr at the most, etc.
Celebs, former astronauts, political figures etc often sit on BOD's for large companies, getting paid easy money to lend their names, status, connections, etc. It's good money for a few meetings a year.
I'd need to look at their 10-K to find out what Langer and others are getting paid in annual compensation and more than likely shares of stock, options, etc for their BOD participation. It'll be in the SEC filings somewhere. I might check it out later.
"What is all the speculation about? WE ARE NOW TRADING ON THE NASDAQ"
Actually, it's NEVER traded on the NASDAQ and is 100% for certain trading as an OTC stock, as it always has been.
NO speculation at all- it's 100% for certain an OTC traded stock.
"looking good here"???
It's trading at a 8 or 9 month low on practically nothing volume- maybe $3K to $5K total a day, except on the huge sell-off, dump days.
It's down 50% in just about 2.5 months or so. It's making lower lows and lower highs, despite multiple efforts to put out "PR" about anything possible, despite "news" about the dilutive Magna "credit line", etc
Now, they're mired in what appears to be a pretty large lawsuit involving all the Sr. Mgt and Northstar LLC and the ex wife of the former CEO and a key creditor, a guy involved with Grey Stone who's lent a lot of money to them in the past. They're seeking $2.3 million plus interest in damages and this all had to be put in a revised prospectus for the Magna credit line, because it looks like Magna and/or Bioheart determined it a serious enough "material event" that it needed disclosure in the share registration statement.
A $2.3 million judgement or even a fraction of that would more than likely put BHRT in BK IMO as they have about $250K total assets to their name and almost no cash at any given time.
From this latest SEC filing, Form "Prospectus Filed Pursuant to Rule 424(b)(3) (424b3)" PAGE 75:
http://ih.advfn.com/p.php?pid=nmona&article=64900333
"Legal Proceedings
On November 10, 2014, the Company was served with a lawsuit by an alleged assignee and a guarantor to a Loan Guarantee, Payment and Security Agreement. These parties claim breach of that Agreement and damages of approximately $2.3 Million plus interest. The assignor and assignee also sued the Company’s directors and a past director and an affiliate shareholder for breach of fiduciary duty, claiming damages as alleged creditors arising out of these parties' alleged participation in Northstar Biotech Group, LLC, a secured creditor of the Company."
Farview,
"Frankly, my guess is a Hopalong has suggested and that is OCAT does NOT meet the financial requirements given the failure so far of the offering, among posible other assessments of the company's history which nasdaq has found troubling? Maybe not?"
Bingo. I think that's the keys to the puzzle. They need the $4 mil in shareholder equity which they do not have at this point. It was logical that they'd close the secondary and up-list as near co-events.
Again, the only thing in my mind that explains the massive train wreck now known as Dec 18th, the uplist-sorry-we-didn't-uplist day is that they abruptly pulled the plug on the secondary.
That secondary money is what would instantly give them the shareholder equity they'd need. I don't think they can tap Lincoln in a single draw that would equal that much money without crushing their share price and the Lincoln line I'm sure has per-draw-down limits. I'd doubt they can pull $4 mil plus in a single draw. Also, they're using and need Lincoln just for their month to month cash burn money. As soon as they draw $4 mil for example, then pay a month's worth of bills, they'd drop right back down below the shareholder equity numbers.
Thus, they need and would like to, my guess, put the big number "on the books", the $50 mil cash or whatever it turns out to be and lock in their shareholder equity and other NASDAQ minimums 100% solid w/ no risk of teetering on the edge of qualifying.
That's my guesstimate, 2 cent thought process- on how this played out. Something triggered Friday Dec 18th to happen- a big ole snafu. NO WAY that was some minor technical glitch IMO. They had a plan, and something major went amiss and someone didn't get their market uplist pulled on-time and they spiraled into the mess ending in FINRA daily list, the 8-K disclosure just filed that essentially disclosed they did not uplist and by the way, everything is pushed out to Q-1 2015. Else, what was that 8-K even filed for?
Explain the events of Friday Dec 18th then, in detail. And then explain the subsequent 2 weeks and the FINRA need to "re-instate" to OTC and all the rest.
Looking forward to the exact details. Thanks.
The 90 day requirement (above $4 a share) is BEFORE APPLYING, thus OCAT which did their R/S on August 28th has been above $4 a share for over 90 days.
They are NOT under any "90 day requirement" in order to apply/up-list to the NASDAQ and there is nothing "magic" about Jan 7, 2015.
The 90 days would have been completed 90 days post Aug 28th which is/was about Nov 28th, 2014.
The proof in the pudding is that they clearly "thought" they were "up-listing" which was the fiasco that began on Friday, Dec 18th, 2014. Obviously they thought they'd tie it in somehow with the secondary- but something (the secondary did not pull demand, would not price high enough)- something went amiss on the entire plan and they pulled the plug.
That's the only explanation of why the stock CLEARLY, w/o debate started showing as being on the NASDAQ, including on the company website, had a template page created on NASDAQ, began to mis-quote, become untradable in retail accounts and then FINRA had to step in and require several days of making the "daily list" to show "re-instated" to OTC, as the NASDAQ uplist never occurred. They clearly "tried" to uplist- that many steps don't happen by mistake. The company had clearly told NASDAQ and probably via the underwriters and their legal firms to uplist them on Dec 18th, but again, yanked the plug.
They are NOT presently under some 90 day wait until Jan 7th. Simple as that. Read the NASDAQ listing requirements on the NASDAQ site itself- it's pdf document that explains it all. 90 days is PRIOR to applying, meaning they had to have 90 days above $4 before they could speak/ask NASDAQ about an uplist. Those 90 days finished around Nov 28th, 2014 after maintaining above $4 a share from the day the R/S was completed. It's not that complicated.
Their 8-K made it crystal clear, they are "in dialogue with NASDAQ" and they gave no specific date, certainly not Jan 7th, 2015. If there was a specific date, they'd have given it in that 8-K filing.
(Oh, and they still have problems in the shareholder equity department, I believe. Need to double check NASDAQ latest, but as of past rules, OCAT would potentially have a problem still in shareholder equity, as the secondary DID NOT OCCUR, thus they did not put the cash on the books and would only have about $750K equity today, and it's $4 mil minimum I believe- that is probably their biggest issue right now and what screwed the pooch, causing the plug to be yanked- as they probably balked on the secondary pricing, which was supposed to happen and coincide with the NASDAQ uplist. That not happening botched the entire deal- but someone didn't get to the OTC/NASDAQ in time on the 18th and stop the transfer from taking place- thus a 2 week mess that the stock is still mired in.)
farview,
Could not agree more. I just read that wash-list on the "patent statements".
It's a mind blower to say the least. I won't even cut-n-paste or repeat the list, it's so far out there lost, but it's like 50 or more serious maladies?
1) Essentially, it's being "claimed" that little ole OCAT now holds the keys to "cure" pretty much EVERY serious malady and chronic disease known to mankind. Pretty amazing stuff for $6.30 stock and what, 30 employees or something? Considering that EVERY major university in the country and EVERY major pharma and bio-med company in the country is working on every last one of those maladies in that incredible wash list, and via literally $BILLIONS being spent and 1000's and 1000's of the finest medical minds in the world, with years-decades of research dedicated and they've yet to solve or provide "cures" for that wash list. But little ole OCAT apparently has it all in the bag and is a hop and a skip and a few bucks away from putting it all on the shelf at your local Walgreens. Right on. Cool. Sounds good to me.
2) The "claim" that just "X" or just "Y" "patent" or whatever is worth $BILLIONS, yet amazingly, no "smart money" is beating a path to the door of OCAT to get at those imaginary $BILLIONS. If OCAT were worth anywhere near that- a hostile buy could be made and suck up every last share off the OTC and own the company for a song- but of course that hasn't happened. Further, in 15 plus years, no top-shelf venture folks have come to fund this company with non dilutive equity stakes, despite old OCAT holding the supposed keys to the universe. Those Menlo Park boys are pretty darn sharp and have bought into some of the most successful companies in world history and little ole MA, right in OCAT's own backyard has a "venture capital row" of decent fame that is no sluff or bunch of duffers either- and yet none of them have ponied up to fund this multi $BILLION world changing miracle, hidden gem??? How can that be? Why is that?
It's easy to make vast, grandiose, hype, hyper-inflated "claims" that have zero basis in reality. If I had a dime for every OCAT "prediction" ever made that never came true- I'd be in the centi-millionaire's club. Easy. More wrong, and totally wrong "predictions" for years about this company than probably any other one I've followed. And most of that bad info originates and then gets cut-n-paste repeated from good ole icell. The center for financial and biz illiteracy, mixed with a near cult like following that is so blinded to reality- and fed so full of bad info and hype and super-stories and what not, that it's the blind leading the really blind IMO.
If this company was worth a fraction of what all these vast "claims" are stating- someone "in the know" would have bought it or funded it or whatever. NOTICE, not a SINGLE INSIDER BUY, NOT ONE using their own money. The stock was literally at 5 CENTS a share- and no insider bought so much as $20 bucks worth.
If you or I were an insider- and we KNEW, KNEW for certain as all these "vast claims" are stating- that we held literally something more valuable than gold in our hands- we'd mortgage our properties, we'd take out loans, we'd sell everything we had and we'd BUY, BUY every last share we could accumulate. Cause according to these vast, fantasy based "projections", in a yr or two, we'd make 20 or 40 or 100 times return on our money and be filthy rich. But reality? NO insiders have barfed up so much as $6.50 for a single share, the price of a Big Mac meal and drink
Says all one needs to know IMO.
A little pay to promote penny stock video, looks like.
http://www.publicwire.com/contact/
http://www.publicwire.com/services/
The little promoter outfit is right in Florida from their web site. Appears to be a tiny little penny pay-to-promote outfit. The same, single guy is shown in all videos and in their contact and sales video- where he pitches their services.
BHRT must be trying the paid penny promotion angle again, looks like. Based on today's closing price and volume- this stunning and fascinating video must not have made the big hit parade list just yet?
Nice little clip though - has 7 views so far. Not bad. The guy doesn't list his "package" prices on the web page- one has to call. Wonder what it costs?
"$25,000 per patient for 120 patients, single injection as out patient is more than than ample over one year and perhaps $40,000 total per patient with the second year follow-up."???
No. Not how clinical trial spending works. Again, WHY are they out trying to drub up $60 MILLION in cold hard cash, via pure dilution? Why? And why did they open and file, on the record, a $100 MILLION shelf to have available to tap-out as needed? Because $100 MILLION is a well known industry "average" to conduct a typical pharma-bio phase II. That $100 million number is published all over the place in financial and journal articles discussing the costs of clinical trials. $100 million is actually on the low side for a decent phase II.
So why is mgt out seeking an initial $60 Ma MILLION? Cause they know they're gonna need it, that's why. It costs big money to draft SEC filings and prospectus documents and file and hire law firms to put all that together, as well as, hire qty-3 underwriters. Those people don't show up and work for free. They've probably spend $500K already just in setting the table to "try" and get that funding in place.
It's nice just to invent imaginary numbers- but those numbers have never been seen or heard of in any phase II in modern times I'm familiar with? Management wouldn't be out hunting for large money for no reason. $3 to $5 mil is noise level money- they'd just use Lincoln in that case and be done with it. Again, they're already consuming about $2 million a month and that's running no trials right now.
"Pivotal Phase2B 80 to 120 Patients could be $3 to $5 mil over 1 to 2 years. "???
Uh, a zero must be missing somewhere there? 80 to 120 patients in an FDA quality phase II for $3 to $5 mil, spread over 1 to 2 yrs? That's the first, down payment for the first month, correct?
It's more like $50 million on the low side and 2 yrs easy. $3 mil doesn't even get a phone call returned from a contract service agency who's gonna hunt down and enroll 80 plus patients.
No way they get anything even remotely done for $3 to $5 mil. They're spending $2 MILLION a month right now just to keep their doors open- and all they had to show for that was a tiny phase I. They've made it clear they need a lot of cash. Round 1 of the $100 MILLION shelf is seeking out $60 MILLION in pure dilution money. Why would they be going after that kind of coin if $3 to $5 mil gets it done for um?
No way. Not a chance. They'll be spending $3 million a month just in general cost and burn-rate once they ramp even into the beginning of running these phase II(s).
$230 bucks traded, 1 hour into trading day. (almost 1.5 hours now actually)
A single, 17K share trade about 15 seconds after open. Then it's totally flat-lined out. Volume is gone, an hour passed now and not a single trade printed.
Looks like perhaps the Magna and Asher and other "Wall Street boys" are more than likely gone for the holidays already. Pretty typical on Wall Street, that those type of firms just button up and totally shut down and leave town. Probably not back really until after Jan 1, 2015.
Bid is still low, parked at .0124. No "news" or PR or the Magna line or anything has really budged it off bottom looks like.
Looking like some pretty tough sledding in here- the large amounts of Magna dilution shares hasn't even really gotten underway or hit in any serious way yet.
Very technically weak in here IMO.
"The "placebo effect" is FDA blind.... but there is no way a placebo effect would allow a person to see a darn eye chart.... its pretty darn basic... "
Once again, a TOTAL lack of any understanding of basic science. And how many people, out of the 6 BILLION plus on earth- supposedly "saw the eye chart"?? How many and for how long have they been tracked and against what baselines and broad cross section of a variety of population sub-set(s) have they been compared and measured and about 500 other variables, YET UNKNOWN when a "study", a very small trial, is barely out of the lab.
WHY, are phase II and III trials needed and conducted, if SHAZAM, you and a few people see a few powerpoint slides and "declare" by fiat, that by golly IT WORKS, PROVEN SAFE and EFFECTIVE and NO SIDE EFFECTS or long term problems in all humans, across all races, ages, health side effects, co-morbid disease states, etc?? HOW would the FDA and OCAT know how to label it, administer it, in what doses, what would the side effect sheet read when handed out by the physician or pharmacy- ever see one, not the little "cut sheet" given to Joe Blow by the pharmacy, but the full "fold out" version that comes to the physician in micro-type print, like a small book- WHO WRITES THAT and why and how if it's all just a DONE DEAL, SLAM DUNK, 2 steps from INJECTING AWAY?? Hey, it's ONLY the freaking human eye- about as close a MAIN-LINE into the human brain that one can get via the optic nerve. Want to put a drug into the brain- RIGHT THROUGH THE EYE, straight and near instant path, what could possibly go wrong? EASY, SLAM DUNK. 18 people, in a micro "trial" and some "eye chart" and SHAZAM, shoot it up and lets get going, right?
How bout this one- how is the set size, the number of people for a phase II or phase III even calculated and why? Explain that one from the stand point that the FDA uses to determine statistical relevance. Why is it 187 patients or whatever, for example, in a particular study. How and by what methods do they determine that number? If one doesn't know -then they know zero about the clinical trial research process.
Who sets the criteria that need to be measured to show the statistical relevance and confidence interval and standard deviation from some baseline, etc? Why do they even bother with all that nonsense- it's a DONE DEAL cause an "eye chart" was looked at and some reports were written. Hey, NO researcher ever gets the results they want in the early stages, right? HAS NEVER HAPPENED- only like ALL THE FREAKING TIME. Tell ya what- you give me something you want a "study" done on. You tell me what result you want and need. I can GUARANTEE YOU, that I can design a good, credible, highly scientific looking "study" and measure lots of variables and produce a lot of data and run it through statistical programs, make lots of charts and graphs,etc and I can give you ANY RESULT YOU WANT and it'd look pretty darn good and be a pretty tough nut to crack to prove it wrong, w/o a lot of work and effort. Big pharma is FAMOUS for it- they "shelve" or "drawer" data and certain "studies" all the time and then select the ones that give the results they're looking for- it's well documented and well known.
Thus, the FDA is the gatekeeper and thus the stricter and stiffer protocols and more timely and more expensive and now often larger phase II and phase III trials. And the FDA can, and often does, even ask for more than one trial if they feel the results are not conclusive or clear or are clouded or the data looks tainted or any number of issues that constantly come up in trials. BUT, an "eye chart" was used so IT'S DONE. FINISHED- it's about 3 months from HITTING THE SHELVES, with even fabricated COST PER EYE numbers- even though no manufacturing line (FDA APPROVED OF COURSE) or process has been written and vetted yet, and no manufacturing line exists and has been FDA vetted and approved- who knows how this would even be made or what container it must go in, shelf life testing and the FDA's MEGA PET the LABELING of the container and packaging. Wanna see an operation get shut down- just MIS-LABEL A PRODUCT and ship it to a hospital or doctor or whatever. The FDA goes ballistic over labeling- so how is this product that does not exist yet going to be packaged and labeled? Does it react to a plastic container perhaps and maybe need to be in a glass vial, as certain IV products still are? Who can know that at this point? What temperatures must it be stored at and for how long? Ever worked an FDA regulated facility or line- ever seen what FDA compliance and an audit is like- what they look for and ask for and demand to know? Ever start up an FDA line for a single product- how long does it take? Is this product hand made or does it use automation, what kind of process controls will it need and who's gonna write that documentation and then go through an FDA acceptance and sign-off and start up? What's the containment and recall process if process controls are breached or suspected bad product is made? Is that written or in existence yet? WHAT? Oh, the PRODUCT HAS NEVER BEEN MADE YET, let alone MADE IN VOLUME in its final, 100% FDA tested and approved form...Ooooh. I see. Yeah. BUT IT's A DONE DEAL- cause you know, an "eye chart" was used and all. Shoot, pretty much done deal.
Here's the 100% FALSE assumption being made- that this is a DONE DEAL, that the phase II and phase III trials are a guaranteed success and that nothing can possibly go wrong in them or trip them up etc. So, WHY is OCAT about to spend upwards of $100 MILLION dollars minimum, and years, to even waste their time to conduct these trials??? WHY? Why even do it- cause you and a few others have said, emphatically, "IT WORKS, IT's PROVEN, IT'S DONE".
SO WHY are these supposed "best minds" out beating the bushes for $60 MILLION freaking dollars to blow- if they don't even need to according to you and a few others? HOW CAN THAT BE? WHY? Why - they just like to spend money on worthless testing? Is that it? WHY? WHY? In detail- WHY $60 MILLION just to get started? WHY? Why would they do that- IT'S DONE and FINISHED and WORKS according to the "old time" geniuses who have "been on the board" per their self proclaimed years or whatever?? WHY? WHY $60 MILLION? WHY?
It's actually 90 days above $4 BEFORE applying. They're not under any 90 day restriction right now.
There's nothing special about Jan 7th, 2015 or whatever the date being bantered about is.
Their own 8-K filing simply implies they delayed it- it's clearly linked to the issues surrounding their lack of ability to apparently get adequate pricing power and demand on the secondary. Further, Wall Street essentially shuts down from about today to past Jan 1, in terms of investment bankers and similar activity, it's a literal ghost town.
They clearly screwed the pooch and "tried" to make a go at the "up-list", probably thinking the secondary was going to price and place. Else, there's nothing to explain what occurred from Friday Dec 12th to today. The stock clearly got FUBARED, and showed supposedly "up-listing" then had to go to the FINRA "daily list" to show it in fact never did and was "re-instated" to OTC for several days in a row. I read the FINRA site with my own eyes each of those days. It took days to get it to even get semi back to quoting properly or showing properly in people's brokerage accounts and on-line timely price quote screens and similar.
What, how did all that occur? By chance? No, they "tried" and "thought" they were "up-listing" and someone pulled the trigger by mistake- only to rapidly have to try and back-peddle and undo the entire mess. It's still not fully settled back in as of today- that's how royally messed it was.
It's not because of some 90 day whatever. It's caused they boned it up and that's what the 8-K was put out to say- that everything hyped and pumped was not "delayed" into Q-1, 2015 at a minimum. Q-1 is any date from Jan 1, 2015 to March 31st 2015. Simple as that.
"If OCAT's "tiny, tiny Phase I trial" produced a 20/400 to 20/40 result, and efficacy in 17 of 18 patients, with a "placebo affect" imagine what we're gonna do in Phase II with the real thing! "
It's 100% clear one does not even understand what the "placebo EFFECT" (not affect) is or even means. No surprise.
Very few posses an actual education or strong background in actual "science" or even a rudimentary background or any actual understanding of the "scientific method" or its application to real world problems and almost none posses any background or formal training in probability or statistics- which is a grad level course to even scratch the surface into trial or engineering study front-end design, how to calculate population or sample set sizes, how to properly blind, how to screen and insure data is free of inherent bias, etc.
The statement/post above shows a total ignorance (lack of education or understanding) as to what the placebo effect is or even means. It would not be the placebo effect that was "claimed" to produce the reported results in the very, very tiny study. It's the opposite. It's that the "claimed", non-blinded results, when put up against an actual placebo arm, may be unable to show statistical improvement any better than the sham "treatment". That's it in a very, very basic laymen's terms.
It's not unusual to have little or no understanding or ability to understand it- it takes a significant education and strong background in actual science or engineering and use of probability and statistics- and most will posses none of that.
No surprise here.
" Negotiations with potential pharmaceutical partners is always hardball tactics and IMO $OCAT will wait until Jan 7 for listing and not concede"
1) What negotiations with what "pharmaceutical partners"??? The company already made statements making it pretty crystal clear they're plan is to "go it alone" and they just took on all the expense and effort of bringing on qty-3 underwriters to "try" and pitch and sell shares to raise them cash to give them a shot at going it alone. Where are these imaginary "pharmaceutical partners" information coming from exactly? What would they be in "partnership" for exactly and why?
2) What is magic about Jan 7, 2015 for "listing"?? The company just filed a 8-K with the SEC and all it said was "in dialogue with NASDAQ" and nothing more. Absolutely no indication of a date or date(s) was given. All other info in that 8-K referred to other events as being scheduled for Q-1, 2015 which would encompass the entire range of dates from Jan 1 2015 to as late as March 31st 2015. That is Q-1, 2015.
How can anything else be inferred or imagined from that 8-K filing?