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Or is there something specific hurting the chances ?
The following needs to be done prior to any NIH approval. This has stalled out due to lawsuits etc;
(February 2010)
WASHINGTON - The National Institute of Health's proposal to revise its definition of human embryonic stem cells (hESC) to permit earlier stage embryos may at first glance appear to be a minor technical change. But to firms like Advanced Cell Technology Inc., which has sunk a "fortune" into developing the cell lines, it is "hugely important," said Robert Lanza, chief scientific officer for the Worcester, Mass.-based biotech.
The NIH late Friday afternoon proposed changing the definition of hESCs issued in guidelines last July from "cells that are derived from the inner cell mass of blastocyst stage human embryos" to "pluripotent cells that are derived from early stage human embryos, up to and including the blastocyst stage." (See BioWorld Today, July 7, 2009, and Feb. 22, 2010.)
That change would allow ACT's five single-blastomere lines currently under review at the NIH to receive federal funding for research, if approved by the agency. ACT currently has an investigational new drug application (IND) under review at the FDA for a Phase I/II trial using its MA09 single-blastomere line to treat Stargardt disease, a genetic condition and the leading cause of juvenile blindness in the U.S., Lanza told BioWorld Today.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=46950661
My point is a very simple one. Have you EVER heard via ACT they are waiting on NIH cell line approval to move forward? Or has it been more like the following? If in fact they are waiting on NIH approval, then saying so would be a novel idea?
“The Company enters 2011 in its strongest financial position ever,” said Gary Rabin, ACT’s Interim Chairman and CEO. “Through a combination of the cash on hand and ability to sell Socius additional Preferred Stock, we believe we have the financial resources to take our lead program in Stargardt’s Disease, a form of juvenile macular degeneration, well into clinical development and to move our program for treating Dry Age-Related Macular Degeneration through the clinic if we receive FDA clearance. Less than one year ago, the Company was significantly in debt and lacked the financial resources to take even one program through the clinic. Today, we are essentially debt-free and have the financial ability to move both of our promising programs through the clinic. We believe 2011 will be a year filled with exciting developments as we begin to get data from these programs.”
per ACT,
(from last 10K)
The diseases and medical conditions we are targeting have no effective long-term therapies. Nevertheless, we expect that our technologies and products will compete with a variety of therapeutic products and procedures offered by major pharmaceutical companies (in the Retinal Disease indication one of our primary competitors is Celgene). Many pharmaceutical and biotechnology companies are investigating new drugs and therapeutic approaches for the same purposes, which may achieve new efficacy profiles, extend the therapeutic window for such products, alter the prognosis of these diseases, or prevent their onset.
In the general area of cell-based therapies (including both ES cell and autologous cell therapies), we compete with a variety of companies, most of whom are specialty biotechnology companies, such as Geron Corporation, Genzyme Corporation, StemCells, Inc., Aastrom Biosciences, Inc., Viacell, Inc., MG Biotherapeutics, Celgene, BioHeart, Inc., Baxter Healthcare, Osiris Therapeutics and Cytori. Each of these companies are well-established and have substantial technical and financial resources compared to us. However, as cell-based products are only just emerging as medical therapies, many of our direct competitors are smaller biotechnology and specialty medical products companies. These smaller companies may become significant competitors through rapid evolution of new technologies. Any of these companies could substantially strengthen their competitive position through strategic alliances or collaborative arrangements with large pharmaceutical or biotechnology companies.
The biotechnology and pharmaceutical industries are characterized by intense competition. We compete against numerous companies, both domestic and foreign, many of which have substantially greater experience and financial and other resources than we have. Several such enterprises have initiated cell therapy research programs and/or efforts to treat the same diseases targeted by us. Companies such as Geron Corporation, Genzyme Corporation, StemCells, Inc., Aastrom Biosciences, Inc. and Viacell, Inc., as well as others, many of which have substantially greater resources and experience in our fields than we do, are well situated to effectively compete with us
http://www.sec.gov/Archives/edgar/data/1140098/000114420410013897/v177442_10k.htm
We have known for over a year that the FFB cannot get involved unless the MA09 cell line is NIH approved for federally funded monies. That is nothing new and NIH approval doesn't seem very close at this juncture.
Published: February 19, 2010
"As a private company, Advanced Cell itself is not bound by N.I.H. rules, but its clinical trial, to be conducted with the Foundation Fighting Blindness, will be supported by the Department of Defense, so the institutes’ approval of the cells is required, Dr. Lanza said."
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=46863846
thanks rumit,
Shaking my head here, how many times since the SMD gained FDA clearance has ACT touted the fact they don't need funding to start trial? And then 4 months later we read the following..so, is it really because of so much interest from different clinical sites or something else that we haven't started SMD yet?
"For ACT, the funding restrictions also threatened to delay a clinical trial. The company had been counting on funding from the Foundation Fighting Blindness, a non-profit organization based in Columbia, Maryland, to back its trial of a therapy for Stargardt's disease, a hereditary cause of blindness in children. But the human ES cells in the therapy were derived from a blastomere, and as the foundation draws its clinical-trial support from the federally funded National Eye Evaluation Research Network, it was barred from contributing to the costs of the trial."
"We're tearing our hair out over here," says Stephen Rose, chief research officer at the Foundation Fighting Blindness. "We really wanted to help fund this trial." Eventually, ACT pulled money from its other research programmes to fund the trial, which is scheduled to begin later this year.
Member states of the EU
http://europa.eu/abc/european_countries/eu_members/index_en.htm
Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that, working with the European regulatory consulting firm TMC Pharma Services, it has filed for Orphan Drug Designation with the European Medicines Agency (EMA) for its Retinal Pigment Epithelial (RPE) Cells for use in treatment of Stargardt’s Macular Dystrophy (SMD), also known as Stargardt’s Disease. Orphan drug designation may provide ACT with several advantages, including ten years of marketing exclusivity for embryonic stem cell derived RPE cells upon market authorization for the indication, financial incentives such as fee reductions or waivers, provide free scientific advice during the drug development process, and access to a centralized review process for all 27 member states.
http://ih.advfn.com/p.php?pid=nmona&article=45774780
The FDA approval for SMD Orphan status covers the US market while the EU approval would cover a 27 state area. It enlarges the marketing area significantly..
, how often does the EU also award orphan status?
it happens on many occasions. Not uncommon at all.
ACT Interim Chairman and CEO Gary Rabin to Present at BIO-Europe Spring 2011 Conference
Advanced Cell Tech (OTCBB:ACTC)
Intraday Stock Chart
Today : Monday 14 March 2011
Advanced Cell Technology, Inc. ("ACT"; OTC Bulletin Board: ACTC), a leader in the field of regenerative medicine, announced today that Gary Rabin, the company's interim chairman and chief executive officer, will be presenting at the BIO-Europe Spring 2011 Conference, March 14-16, at the Milano Convention Centre in Milan, Italy. Mr. Rabin's presentation is scheduled for Wednesday, March 16, at 10:15 a.m. CET, level 1, room Yellow 3.
Webcasting is not available but following the conference a copy of Mr. Rabin's slide deck will be available on the company's Web site at http://www.advancedcell.com.
Speculative Biotech Firms Grind Through Regulatory Process
Advanced Cell Tech (OTCBB:ACTC)
Intraday Stock Chart
Today : Monday 14 March 2011
There is plenty of optimism surrounding the Biotech industry as firmer pricing and new products have improved sales and earnings trends. Meanwhile, younger, more speculative biotech firms continue to garner significant attention with potential blockbuster drugs working their way through the regulatory process. The Bedford Report examines the outlook for companies in the Biotechnology Industry and provides research reports on Advanced Cell Technology, Inc. (OTCBB: ACTC) and Novavax, Inc. (NASDAQ: NVAX). Access to the full company reports can be found at:
www.bedfordreport.com/2011-03-ACTC
www.bedfordreport.com/2011-03-NVAX
A recent study released by BIO and BioMedTracker claims that the success rate in bringing new medicines to market in the past six years is only about half of what it had been previously. The study claims, however that biotech drugs are twice more likely to gain approval than more traditional chemical drugs.
The study finds that drugs moving from early stage Phase I clinical trials to FDA approval is roughly ten percent, down from around 20 percent in reports involving earlier years.The report adds that approval applications were filed for 55 percent of the drugs that made it to Phase III testing, and 80 percent of those gained eventual approval -- though only half were approved on initial review.
The Bedford Report releases regular market updates on the Healthcare Sector so investors can stay ahead of the crowd and make the best investment decisions to maximize their returns. Take a few minutes to register with us free at www.bedfordreport.com and get exclusive access to our numerous analyst reports and industry newsletters.
Regulatory approval of drugs is a process that frequently comes under fire for being too rapid or too slow. The FDA has reacted to long standing criticism by streamlining some of its guidelines and procedure. Europe's EMEA has largely resisted expediting its approval process. A recent study suggested that the European drug approval system takes twice as long to approve cancer drugs than does the FDA, adding fuel to recent criticism of the European drug approval process.
Last week the European Medicines Agency's Committee for Orphan Medicinal Products granted Advanced Cell Technology a positive decision on its human embryonic stem cell-derived retinal pigment epithelial cells for treatment of a genetic disease that causes progressive vision loss. The opinion now goes to the European Commission, which will determine whether to grant the orphan drug status. The U.S. FDA approved an orphan drug designation for the same product last year.
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jt,
No trials have even started yet and when they do think years not weeks to complete. Link below MAY be of some help.
http://www.advancedcell.com/documents/0000/0285/ACT_Corp_Pres_2011-BIO_CEO_2.15.11.pdf
Mail ? on todays PR,
"when ACT receives Orphan approval can we start trials in Europe?
No. The EU requires a CTA to be filed(clinical trial authorization). This is similar to filing an IND here in the States like ACT did with both SMD and AMD.
To understand the similarities and differences between the
EMEA and FDA requirements for initial submissions of new
medicinal products
http://www.pharmatek.com/pdf/PTEKU/Sept232008.pdf
I was in this stock for a very short while Rich, just long enough to make a few coins. I check the board now and then to see if anything has changed but it hasn't. These non reporting pinks have it made. At the stroke of a pen they can up the authorized shares and issue them at will. IMO, basically a private company with ability to shed shares in public market. No accountability and transparency is what they want it to be. It is tough enough when you deal with SEC reporting companies so I choose only to "play" with pinks if I feel a chance to recoup in a short time. Pink sheet reporting should be mandatory, as minimal as it is, or else you are gone...good luck and hope things do change for those here...
I don't think anything with Identa is significant...lol I posted thinking it was what Emily was looking for..
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=60784426
"The meeting went well and the chain officials are very interested in offering the Identa products under their private label.
"Identa will supply in the next few weeks, samples of the new General Drug Screening Detector for the American drug store chain, to design it with a private label.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=60359992
No time frames?
the first example shows it took almost 2 months from "positive opinion" announcement to actual approval..
the COMP adopted a positive opinion on 3 December 2009 recommending the granting of this designation.
On 2 February 2010, orphan designation (EU/3/09/720) was granted by the European Commission to Oxford BioMedica (UK) Ltd,
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=60795995
The other two were recent examples of companies that announced "positive opinions", as we did today, and have NOT received approval as of yet.
(49 days..no approval)
ZIOPHARM Receives Positive Opinion for Orphan Drug Designation for Darinaparsin from European Medicines Agency
Jan 20, 2011
http://ir.ziopharm.com/releasedetail.cfm?ReleaseID=544639
(44 days..no approval)
01/25/11 Alnylam Receives Positive Opinion for Orphan Drug Designation from European Medicines Agency for ALN-TTR01, an RNAi Therapeutic for the Treatment of Transthyretin-Mediated Amyloidosis
http://phx.corporate-ir.net/phoenix.zhtml?c=148005&p=irol-newsArticle_Print&ID=1519451&highlight=
well, first example was 2 months and here are a couple others that PR'd "positive opinion" that have yet to announce approval. Recent examples that one would think can serve as a guide, but who knows.
ZIOPHARM Receives Positive Opinion for Orphan Drug Designation for Darinaparsin from European Medicines Agency
Jan 20, 2011
http://ir.ziopharm.com/releasedetail.cfm?ReleaseID=544639
01/25/11 Alnylam Receives Positive Opinion for Orphan Drug Designation from European Medicines Agency for ALN-TTR01, an RNAi Therapeutic for the Treatment of Transthyretin-Mediated Amyloidosis
http://phx.corporate-ir.net/phoenix.zhtml?c=148005&p=irol-newsArticle_Print&ID=1519451&highlight=
example cited was approx. 2 months..eom
The following "summary' is what you can expect to see when Orphan status is approved by EU commission and gives an example of time frames..
Public summary of opinion on orphan designation
Lentiviral vector containing the human ABCA4 gene for the treatment of Stargardt’s disease
the COMP adopted a positive opinion on 3 December 2009 recommending the granting of this designation.
On 2 February 2010, orphan designation (EU/3/09/720) was granted by the European Commission to Oxford BioMedica (UK) Ltd, United Kingdom, for lentiviral vector containing the human ABCA4 gene for the treatment of Stargardt’s disease.
http://www.ema.europa.eu/docs/en_GB/document_library/Orphan_designation/2010/03/WC500075159.pdf
Decent site if you haven't see it.
Last 10 years
Status of orphan-designation applications
• A total of 1113 applications have been submitted to date for the designation of orphan medicines.
• A total of 760 positive opinions on orphan designation have been adopted by the COMP.
• A total of 269 applications have been withdrawn and 16 received a negative COMP opinion
• A total of 724 medicines have been granted orphan status by the European Commission.
http://www.ema.europa.eu/docs/en_GB/document_library/Report/2010/05/WC500090812.pdf
Myoblast has been stalled out for 3 years now so your guess is as good as anyones..It was stated approx. $15MM to restart..
http://clinicaltrials.gov/ct2/show/NCT00626314?term=NCT00626314&rank=1
nothing to update except to say it is moving through the EU established process. Open "submission deadlines" link at post below.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=58639373
Nick,
as far as the large OS# and float I am well documented here as to what I think of it. With FDA clearnace for 2 trials, new financing, several patents PR'd and a huge news blitz for several months we sit around 15 cents per share. While many here think the OS# isn't a big deal, I disagree. If the last 3+ months didn't prove that, nothing will I guess.
What will it take? Here are just a few, the NDA approval is years away so I hope ACT is one of the 15% that make it..
1)Initiate trials
2)Treat a patient
3)Have positive safety results as all of the upcoming trials will be using MA09-hRpe so it is vital to moving forward.
4)Have substantial efficacy results over time.
5)New CEO and BOD's
6)Restructure the shares(for me I hope we try a big board exchange)
7)Quit the massive dilution
8)Pay any and all debts instead of waiting years and having fairness hearings
9)No more GIFTED shares until something is truly accomplished.
10)Some or all of the above will give this company credibility which it sorely has lacked the past 10 years and imo ACT brought that on.
Mail ? Is there a limit to the number of shares a BOD or insider can sell in a week or month?
1% of OS# over a 3 month period. 1% of the OS# of ACT is approx. 15MM shares which translates into about 5MM shares per month limit.
"Trading Volume Formula. If you are an affiliate, the number of equity securities you may sell during any three-month period cannot exceed the greater of 1% of the outstanding shares of the same class being sold,"
"Control securities are those held by an affiliate of the issuing company. An affiliate is a person, such as a director or large shareholder, in a relationship of control with the issuer. Control means the power to direct the management and policies of the company in question, whether through the ownership of voting securities, by contract, or otherwise."
http://www.sec.gov/investor/pubs/rule144.htm
Nick,
fwiw, OS# as of one month ago was 1,449,161,997
Hey Rocky whats Your take on Socious capital and this drop?
no correlation.
rumit,
If they are over and need to address the issue via Proxy are you saying the statement below should have addressed that and it is part of the decline other than normal debt holder selling? Still not quite sure what you are asking rumit.
"The Company knows of no business, clinical or financial reason for the stock's recent significant decline."
rumit,
you asked,
How can they POSSIBLY put out a PR like this, when there is the strong likelihood that we are out of shares to issue?
ACT is NOT out of shares to issue. Please read prior posts on this topic and if you have questions let me know..thanks rumit
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=60396750
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=60198976
I'm hoping they all are..eom
Form 4 filed BOD Ruoslahti sells 500,000..
http://www.sec.gov/Archives/edgar/data/1140098/000101376211000550/xslF345X03/primary_doc.xml
Nick,
there is always lots of good info in the 10K..I will especially want to see the OS# as well as diluted share # to see how soon the Company will need to address things via proxy. I also want to see the Optimus "fairness hearing" deal spelled out which paid off some old debt...the following not directed at you Nick, just tagging on to this reply.
For those sending mail once again asking "what is going on with PPS?".....It is identical to what took place in the 2009 run. The Company issued hundreds of millions of shares and you have seen constant selling for some time now, or at least as much as they could given paltry volume. ACT tells all what they did so I really don't understand why many don't get it...daytrades? MM manipulation?
yep, a small percentage imo, most are debt holders as it has been for years. The writing was on the wall with the 3 8K's filed in late December...Flashing neon lights?..
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=58412055&txt2find=neon
Warrants,
Jon, the warrants(as they are called) for Optimus and Socius financing are NOT the same as the warrants issued to CD holders under the amended terms to fend off default.
The CD holders received warrants that can be exercised at 10 cents any time prior to June 30,2014. When holders exercise these warrants the monies received go to ACT's treasury. When first registered there was approx 192MM warrants. Some of these warrants were cancelled when Bristol received approx. 50MM shares at .02 from lawsuit..The upcoming 10K due by next Wednesday will determine what was exercised. Once again, the warrants for Optimus and Socius are called warrants but do not fit into above category. Hope that helps you.http://www.sec.gov/Archives/edgar/data/1140098/000101376209001837/forms1.htm
I wasn't aware the ACT board was set up not to question anyone...gee, thanks for the heads up..obviously you have a handle on things.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=60393751
so you are counting all the shares the insiders gave to themselves at no cost as "major shareholders"?..Take away " insider holdings" and what do you have? So once they gifted themselves about 140MM shares you then came to the conclusion it was a quality company?
ACTC is still an OTC with major holders.******** to me this is a major signal of the quality of this company for an OTC.
ACTC is still an OTC with major holders
please list the "major holders"
Another Form 4.. BOD Ruoslahti sells 322,050 shares..Approx. 1.5MM shares sold in February..
http://www.sec.gov/Archives/edgar/data/1140098/000101376211000512/xslF345X03/primary_doc.xml
fwiw, monthly volume stats
December....1.22 Billion
January....487 Million
February....132 Million
http://www.otcbb.com/asp/tradeact_mv.asp?SearchBy=issue&Issue=ACTC&SortBy=name&Month=2-1-2011&IMAGE1.x=18&IMAGE1.y=7
ACTC BOD Erkki Ruoslahti,
BioTime+Ruoslahti
"The acquired technology includes technology patented by CTI and an exclusive license to use technology invented by Dr. Erkki Ruoslahti's group at the Sanford-Burnham Medical Research Institute (SBMRI) for use in cell therapy."
http://www.b2i.us/profiles/investor/ResLibraryView.asp?ResLibraryID=43194&GoTopage=1&Category=1802&BzID=1152
The Ruoslahti laboratory in Santa Barbara is a branch of Sanford-Burnham Medical Research Institute affiliated with UCSB
The underlying themes of Dr. Ruoslahti’s work are tumor vasculature and metastasis. Tumors, like other tissues, contain both blood vessels and lymphatic vessels. A tumor needs blood vessels to be able to grow, and destroying tumor blood vessels is the basis of a promising new cancer therapy. Lymphatic vessels are not needed for tumor growth, but like blood vessels, the lymphatics are an important conduit of distant metastasis.
http://www.sanfordburnham.org/research_and_faculty/faculty_search/ruoslahti_e_md_phd.aspx
advancedcell,
we need some sort of update on the effectiveness of the trials...
How is that possible when trial has not started yet?
last transaction date was Feb 18 so the filing was due Feb 22nd.
"Changes in ownership are reported on Form 4 and must be reported to the SEC within two business days."
http://www.sec.gov/answers/form345.htm
Form 4 Filed, BOD Ruoslahti sells 385,551 shares. A little late in filing.
http://www.sec.gov/Archives/edgar/data/1140098/000101376211000511/xslF345X03/primary_doc.xml
north,
all 3 license agreements between Embryome Sciences(subsidiary of BioTime) have been posted many times here and can be viewed by anyone. It is not new or secret by any stretch...If you want them let me know..