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I used "intention" because of the following reverse split that was approved by shareholders and later cancelled. ACT gave themselves a four month window to enact the split. We have the same BOD's now as then so the mindset if they were to condider a rs may be the same. btw to all, this was the last "annual shareholder meeting", we have had "special" meetings to increase shares etc but no annual.
NOTICE OF ANNUAL MEETING OF STOCKHOLDERS
DECEMBER 28, 2007
3. To consider and approve an Amended and Restated Certificate of Incorporation of the Company (the "Restated Certificate of Incorporation"), which amends and restates the Company's existing Certificate of Incorporation to effect a reverse split of the Company's outstanding shares of common stock, par value $.001 per share ("Common Stock"), at a ratio in the range from one-for-two to one-for-ten at any time before May 1, 2008.
http://sec.gov/Archives/edgar/data/1140098/000104746907009523/a2181358zdef14a.htm
we are definitely on the same page then rumit, and that might be somewhat optimistic on timeframe,jmo..
Some weekend reading for those inclined,
Orphan Myths
Orphan drugs have limited profit
Nich markets
Low competition
Longer exclusivity
Loyal customers
Once Orphan always Orphan
NDA amendments to add non-orphan indications
Multiple Orphan designations for the same product
Pricing and Insurance control by regulators
No price control in the US
Insurance companies cannot deny FDA-approved
treatments
http://www.amarexcro.com/articles/docs/Webinar_Orphan_Drugs_Nov2009.pdf
(start at slide 5)
Since 1983
?? Designation requests submitted: 2668
?? Approximately 1900 products have received
orphan-drug designation.
?? 330 orphan-designated products have received
FDA approval for marketing.
?? Approved orphan-designated products are
available to treat patient populations totaling 25
million in the U.S.
http://www.wmshp.org/annual_symposium/Rare_Diseases_Challenge_%20A_Pharmacists_Perspective.pdf
Advantages of Entering the Orphan Drug Space
Market opportunity combined with the decreasing likelihood of success with the blockbuster drug-development model is increasingly focusing big pharma companies on small-market, high-value therapies. U.S. orphan drug revenues reached $32.5 billion accounting for 55% of the market in 2006. Additionally, the U.S. market is expected to grow at a compound annual growth rate of 8%, reaching $47.8 billion by 2011.
Acquiring orphan drugs also gives pharma new science, technology, and manufacturing processes that have the potential to reinvigorate rusty pipelines. In addition, a higher percentage of orphan NMEs, according to one analysis reported in Orphanet Journal of Rare Diseases by Ohio State University and University of Massachusetts, were approved under priority review and accelerated review procedures.
http://www.genengnews.com/analysis-and-insight/big-pharma-adopting-orphan-drug-strategy/71053206/
Ok louisa,
as stated prior, it will most likely take the 10K filing in mid March to accurately depict where we are but rest assured we are getting up there so discusiion is worthy...
When ACT is at the point they need to address this issue, the following are options unless a merger/buyout or something in that form takes place prior.
1)ACT buys back a ton of shares and retires them(I think you have a better chance of winning the lottery twice in a row)
2)ACT does a proxy for shareholders to vote an increase to authorized shares.
3)ACT files a proxy to reverse split and stay on OTC:BB
3a)ACT files a proxy to reverse split with intentions to move to big board exchange.
ilong,
I hear ya, best summed up below.
"It's the clinical trials that take so long--usually several years," says Sandra Kweder, M.D., deputy director of the Office of New Drugs in the CDER. "The emphasis on speed for FDA mostly relates to review time and timelines of being able to meet with sponsors during a drug's development," she says.
http://www.fda.gov/drugs/resourcesforyou/consumers/ucm143534.htm
Addition to OS# post,
the fully diluted count is important for the following reason.
Take our last 10Q, the following was noted.
At September 30, 2010 , approximately 338,868,000 potentially dilutive shares
http://www.sec.gov/Archives/edgar/data/1140098/000101376210002605/form10q.htm
Example:
Knowing we have 1.4 Billion out and if that number stayed the same(it shouldn't be even close) then we would have 1.739 Billion fully diluted to our 1.75B authorized meaning a proxy would be very near term asking for more shares or doing something else.
I fully expect that some 10 cent warrants and 10 cent options were exercised so I don't expect the "potentially diluted" number to be as high as 10Q had Nov.30,2010..also Optimus shares would have been included in 10Q number and they now are in the OS# column so that alone changes things.
Regarding OS#,
The last prospectus filed Dec 6, 2010 had the outstanding share number at 1,139,314,444. Rumit and I had discussions here after the 3 8K's(financing) were filed and given the info available to us we approximated about 1.3B shares out. I found the info below while cruising for some info. ACT has the OS# at 1.4 Billion as of January 6, about two weeks ago. The xtra 100MM shares could have come from exercised warrants/options or something else. I have noted an ACT PR below because I have always been unclear to the one bolded item. Upcoming S-1 or mid March 10K will give us the all important fully diluted number which will determine or at least give us an idea of how soon more shares will be needed or restructuring may occur. Adding 261MM shares to the float in less than 30 days should help everyone understand the pps battle we endure all the time. FWIW, back in the 2009 run to .29, ACT added 260MM to the float also, Groundhog Day?..it has to stop..
Key Market Data
Ticker: ACTC.OB
Closing Price 1/6/11: $ 0.20
52-Week Range: $.04 - .27
Shares Outstanding: 1.4 B
Market Cap: $261 M
3-Mth Avg. Daily Volume: 28 M
http://www.advancedcell.com/documents/0000/0281/Corporate_Profile_updated_01_06_2011.pdf
(end of year PR)
"ACT expects to end the year with approximately $15 million in cash and equivalents, and less than $1 million of debt. The Company recently strengthened its balance sheet by selling 750 shares of non-convertible Series B Preferred Stock to Optimus Life Sciences Capital Partners, LLC under a previously announced $10 million Preferred Stock transaction. ACT also eliminated more than $10 million of indebtedness through conversions and settled more than $10 million of other liabilities."
http://www.advancedcell.com/news-and-media/press-releases/advanced-cell-technology-secures-25-million-funding-commitment/
Ken and all,
Ken, ison, harlem,
Ken, I am in no shape or form an "expert", not even close. I do try and stay on top of things but when it comes to the scientific readings of the patents and trying to get the one up on clinical trials and methods and the FDA I have found it to be very challenging, to say the least. I try and back up my thoughts with pertinent links but it certainly doesn't mean that's the way things will go and I hope investors take ALL info available to form their own opinions. I am sure ACT has a road map for trials but that could change too as things move forward. Treating the first patient with MA09-hRPE is what things are all about right now no matter what may or could come down the road at a later time...
Folks,
Per request, this is my take on upcoming trials. No guarantees, it's just how I see things.
The SMD was chosen to be first in trial because:
(stated by ACT)
a)Highest likelihood of seeing signal in Phase I
b)Significance of Market Exclusivity: Barrier to Entry
c)The only practical choice for first clinical trial involving
RPE cells for macular degeneration.
The Orphan designation allows ACT to possibly complete clinical phases in HALF the time it takes a non-orphan designation. "Signals" of progress can possibly happen during safety study in Phase 1.(big deal,imo) Early positive results combined with more efficacy results may position ACT to apply for an NDA(new drug application) much quicker than any other disease indication. As mentioned in prior post, NDA can be submitted and granted prior to complete testing results being finished. Whether or not we will meet the following clinical benefits I am not sure, but somehow seems to fit.
"Accelerated Approval
Traditional approval requires that clinical benefit be shown before approval can be granted. Accelerated approval is given to some new drugs for serious and life-threatening illnesses that lack satisfactory treatments. This allows an NDA to be approved before measures of effectiveness that would usually be required for approval are available.
http://www.fda.gov/drugs/resourcesforyou/consumers/ucm143534.htm
What the NDA Approval means to me? This is a critical part of any trials. Only about 16% or less of all orphan designated trials receive NDA approval. Not only will it allow the exclusive marketing(7 years) to kick in for a relatively low number of SMD patients but IMO it says much more considering we have the money maker AMD trial most likely running in tandem with SMD at some point. The FDA APPROVED NDA for SMD means that the FDA has assured itself, and the world, the MA09-hRPE cell line is SAFE IN HUMANS. This exact same cell line is being used in the much larger AMD trial so safety Phase there should be limited at best. Mr. Caldwell pounded the importance home a while back also..
William M. Caldwell, Chairman and CEO of ACTC: I think we’ve alluded to some things a couple of times either on blogs or in conferences, and I can start with the approval of our IND for Stargardt’s Disease which we will be seeing some time in the first half of the coming year. (That will mark) us going into the clinic. And we have already alluded to the fact that we will go into multiple sites, not just one particular site, for the reason that we have filed for Phase I/Phase II. For those who are not familiar with that, Phase I really focuses on safety. That’s going to be a very, very important piece, not just because of the safety, but because it will ensure for the FDA that this cell type can be safe in humans.
Once ACT has Orphan Drug Approval established and a non-orphan indication in trials too, I feel the following(below) from my Part 1,2,3 post a while back has a chance to kick in. Knowing the cell type is safe in humans and seeing decent results in SMD patients may have Doctors in the field prescribing off-label usage for injections to AMD patients long before the AMD trial is finished knowing clients won't be harmed and yet the injections may help. Insurance company coverage would be a huge bonus, but not absolutely required if AMD patients are willing to pay out of pocket.
"Once established as an orphan drug, off-label usage and expansion to nonorphan indications can lead to an increase in sales. Genentech’s Rituxan, for example, became a blockbuster drug within a short span of time as it was prescribed for many off-label indications. Drugs such as Centocor’s Remicade have become blockbusters due to expansion to nonorphan indications including rheumatoid arthritis. In fact, 12 out of 19 leading orphan drugs had just one approval for an orphan indication but became blockbusters by expanding to nonorphan indications or by off-label usage"
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=58584839
The above is my take on a potential path for our two hESC trials. Two things are crucial to any of the above transpiring.
1)we have to actually treat a patient and start the trials...lol
2)show safety and positve results at every turn.
hESC trials are new and only one is actually underway. Will the FDA scrutinize to death or actually find the hESC's can be brought through the process quicker than others? We shall see(no pun intended)..:)
Keep in mind 84% of the trials did not receive NDA approval. It is a daunting process and a lot of work. The average NDA is between 70,000-100,000 pages long. Our IND filing was 4050..
louisa,
yes, embryonic inclusion is important to be correct.
Adult stem cells?
http://clinicaltrials.gov/ct2/results?term=adult+stem+cells
rumit,
The trials will hopefully be quick compared to most FDA trials, but they are still going to occupy the better part of the year when you include official results and reports.
I never would have guessed we were tracking the same as the underlined part of your statement above threw me for a loop. If stated, "better part of the next 2 years or more" I probably wouldn't have needed clarification...:)
My findings are showing minimum 2 years for clinical phases.
That may or may not include NDA time of approx. 6 months depending on how it is treated and when filed.(see below)
"Accelerated Approval
Traditional approval requires that clinical benefit be shown before approval can be granted. Accelerated approval is given to some new drugs for serious and life-threatening illnesses that lack satisfactory treatments. This allows an NDA to be approved before measures of effectiveness that would usually be required for approval are available.
http://www.fda.gov/drugs/resourcesforyou/consumers/ucm143534.htm
positive results in SMD trials imo won't be the catalyst but further positive developments into AMD could very well be. Couple of paragraphs below that apply,imo.
"The fact remains that it is still the biotech and small pharmaceutical companies that are investing in the early stages of orphan drug development. Big pharmaceutical companies enter the picture once the drug has passed the discovery stage and a significant part of development, too.
Most often, big companies choose to acquire or collaborate with biotech companies rather than start a new drug development program targeting an orphan disease. This strategy has been a boon for biotech companies, which often struggle with inadequate funding. It has also worked well for the venture capital community, as it provides a good exit strategy."
http://www.genengnews.com/gen-articles/biomarket-trends-orphan-drug-arena-driven-by-biologics/2318/
rumit,
Based on everything I have researched on orphan desiginated clinical trials I find the following to be a common denominator.
1)Time in clinical trials has increased the past few years
2)Amount of time to review/approve an NDA(new drug application) has been cut in half from 2 years to approx. 7 months-1 year.
Using the following chart link below(main article is second link) and you subtract out the IND time and NDA approval time it averages out to approx. 3 years in clinical phases.
http://www.nature.com/clpt/journal/v89/n2/fig_tab/clpt2010286t3.html#figure-title
http://www.nature.com/clpt/journal/v89/n2/full/clpt2010286a.html
I have seen several sights with basically the same info. Most info mirrors the FDA stats "Approximately half of the approvals occurred by four years after being granted designation, and the most common patient population size was fewer than 10,000 patients"
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=58590825&txt2find=clinical
So this suggests once again that AFTER you subtract out Orphan desig time(1 yr) and NDA approval time(7 months), clinical phases average around 2+ strong years..
So whether using FDA stats or mean chart stats, they are both in the same ballpark. I believe it falls more in line with Caldwells statement.."Typically, once a quadrant of patients is treated you will have 90 day, 6 months and one year data points"
rumit,
In a prior post you had said the following,
"The trials will hopefully be quick compared to most FDA trials, but they are still going to occupy the better part of the year when you include official results and reports."
For my own clarification, based on above, at year end you feel we are where in the process?..thanks
There is no logical reason ACT would deviate from their plan or reasons they chose SMD trial to be first..
1)Orphan Drug Designation
• Stargardt’s Disease is the only practical indication with which to begin clinical trial
• Highest likelihood of seeing signal in phase I.
2)ACT has obtained Orphan Drug Designation in United States
Significance of Market Exclusivity: Barrier to Entry
The only practical choice for first clinical trial involving
RPE cells for macular degeneration.
That's the whole point davpar, why change it so far out.
Must be a reason which is the point I was making. ACT changes in timeframes have always been for a reason in the past...we shall see. The "shortly" part for clinicaltrials.gov info is 17 days old so who knows..
no, there is a large contingent that reads this board but do not post here. I don't blame them for that. I post the responses here so they can read and so the the same question isn't asked over and over.
"induce a response from ACTC?"
I know better.
as it turned out that was the problem but you had to dig through a 10K much later in time to even find that out. For those that were around then the trial was a very big deal with many eyes watching but nothing was mentioned by ACT. Why the delay this time is anyones guess.
jon,
"rock, what is your take on SMD trial delay? are you concerned?"
jon, info would dictate there is a delay. December Executive Summary stated protocol was approved and trial sites were designated with patient treatment in first quarter.
http://www.thechairmansblog.com/william-caldwell/wp-content/uploads/2010/12/Executive-Summary-ACT-Macular-Degeneartion-Program.pdf
January 3 PR had stated info to be on clinicaltrials.gov, "shortly"
Mid January Corp. Presentation, "IND approved Nov. 2010
Phase I to begin 1st Half 2011"
I was here when Myoblast Phase 2 was suppose to be on the verge of starting with all clinics in place as well as supplier partnerships and all info submitted to clinicaltrials.gov and 3 years later..nothing..so yes, delays are an inherited concern with ACT..
last week you were posting 1.5B shares out now it is 1.6B? That's in the same category as a post made saying ACT holds 200 patents..just wonderful..
yes, ACT has the only Orphan Designation for Stargardt’s disease here in the United States and currently seeking the same in EU. There are two companies that already have been granted the orphan status in Europe.(see below)..
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
On 6 February 2009, orphan designation (EU/3/08/609) was granted by the European Commission to Fondazione Telethon, Italy, for adeno-associated viral vector serotype 5 containing the human ABCA4 gene for the treatment of Stargardt’s disease.
http://www.ema.europa.eu/docs/en_GB/document_library/Orphan_designation/2009/10/WC500005628.pdf
mail ?,
"rock, how can we have so many shares out, when did the last batch go into effect? Don't the preferred get added into the authorized?"
ken,
We went from 500MM authorized to 1.75 Bilion authorized 16 months ago, see Certificate of Amendment below. ACT averaged 50-60MM shares issued per month, at that rate they disappear in a hurry. The preferred does not get added with authorized. Our Preferred shares have no trading platform so there value is in the common stock conversion. 1.75 Billion is it until they ask for more or do something else.
http://www.sec.gov/Archives/edgar/data/1140098/000101376209002153/exhibit315.pdf
Karin,
ASTM was on the Nasdaq prior to the 1:8 reverse and implemented the reverse to meet continued listing requirements. When big board stocks reverse, that is generally the reason...thanks
We can regain compliance with the minimum closing bid price rule if the bid price of our common stock closes at $1.00 or higher for a minimum of ten consecutive business days, although NASDAQ may, in its discretion, require us to maintain a minimum closing bid price of at least $1.00 per share for a period in excess of ten consecutive business days (but generally no more than 20 consecutive business days) before determining that we have demonstrated the ability to maintain long-term compliance.
We believe that approval of this Proposal would provide us with the ability to meet the continued listing requirements for the NASDAQ Capital Market. We do not believe that having our common stock delisted from the NASDAQ Capital Market is desirable because, among other things, it could reduce the liquidity of our common stock. Even if our common stock’s closing bid price satisfies the minimum closing bid price rule prior to approval of this Proposal, we may still effect the Reverse Stock Split if shareholders approve this Proposal and our Board of Directors determines that effecting the Reverse Stock Split would be in the best interests of Aastrom and its shareholders.
http://www.sec.gov/Archives/edgar/data/887359/000095012309053669/a53958dedef14a.htm
let alone a pink..who's pink?..eom
yep, if or when that miracle happens I agree. Your 90 days isn't even close to reality paul and I think you have to know that. The point of the rs discussion is what is better for ACT the next couple years. Add more shares and stay here or make a move. I wouldn't think of supporting a reverse if I didn't think ACT had a very good chance of capitalizing on several opportunities. The reason it is hard to find good examples is simple, very few companies on the OTC are uniquely positioned like this is. I am not frustrated with any progress but I am being realistic on when it will happen barring any delays. Good luck, whether we move or stay
that is not the case,
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=58698628&txt2find=21|days
http://prsinfo.clinicaltrials.gov/s801-fact-sheet.pdf
(from last PR)
Specific inclusion and exclusion requirements and Investigator contact information will be posted shortly at clinicaltrials.gov. Patients and their caregivers should refer to this source rather than contacting ACT or its representatives.
90 days from now will mean very little(provided we have started trial), Getting the NDA approval to market a successful product will be the turning point which is closer to a 2 yr. timeframe. You may get some early signs of improvement but you won't be telling the world you have a working product when trials are barely underway. With the FDA there will be no touting early progress signs as a world changer. If you are looking at a world changer in 90 days when we haven't even started trials yet then it is no wonder a rs isn't acceptable. lol..Reality?
Good luck with your pps predictions
ACTC in 2005 was trading at about the same price as SIRI in 2006 with around the same shares out .Hmmmmmmmm
How in the world were the share price and shares out even remotely the same?
All figures taken from year end 10K's for each.
ACT:
March 16,2006
approx. 24MM shares out
sp at $1.57
Siri:
March 8,2006
approx 1.388 BILLION
sp at $4.77
Siri ipo'd on the Nasdaq. They have never been an OTC stock trading at .17 with OS# 0f 1.4B or more. ACT would reverse split to gain shareholder value via a big board. That isn't the same as Siri who would reverse only to save their butt from minimum listing requirements. Huge difference. Even with Siri's 1B(25%) ownership by Inst's it will have a tough time increasing pps like the old days. So, your example while irrelevant to a RS performed by ACT, does point out that when you have major dilution it makes it tough no matter where you trade.
daulton,
Your honesty is appreciated. Your example cited $10 per share. I would suggest the following as a consideration...
If back in November it was stated that ACT would have SMD FDA cleared, filed the second IND for AMD and had it FDA cleared, cleaned up balance sheet and secured $25MM amongst other positive PR,s and would receive and have a media blitz for 45 days that was second to none, and 2.5 months later would be trading around 17 cents, what would the response have been here? I will venture a guess the majority here would have said whoever posted that would be totally FOS....Me included to the extent I expected to base and hold higher than our run in 2009. My point is this, this is a factual testimony of how difficult it is to move with well over a billion in the float. Trials take TIME, results take time and that puts us back to where we started, Increase authorized or reverse. JMO, I don't see the $10 pps you presented as even remotely possible under our current structure...thanks
daulton,
Can somebody play devils advocate as to how we will avoid an RS?
1)Sure, increase the authorized again. I believe the upcoming S-1 will indicate the fully diluted share count is at the point where management will have a decision to make, sooner rather than later.
2)Secure a partner soon that for example supplies a substantial funding arrangement not based on shares and takes a percentage or royalty from any products derived.
I am well documented as being pro reverse split on this board. What I am having a hard time understanding is the following. The majority here view ACT as a stock with massive potential and many upcoming events near term and down the road. Most here, like yourself, have stated ACT will be a major player. With all that in place and ACT being on the doorstep of trials and many other things, you folks are fearing the reverse. My question is WHY?
Is it because of the pink sheet OTC mentality where reverses are done just so companies can start issuing shares again with nothing of promise upcoming? I would suggest there is no better situation to reverse and move to a larger board. NOT reverse and stay on the OTC. Examples have been cited where a one time penny has increased pps to a point where they meet the $2-4 minimus listing requirements to go to larger board without reversing. I don't see those examples as relevant because they didn't have a billion plus shares during the sp increase. While some believe we can make the $2-4 pps under current conditions, I am not one of those. Something will have to happen long before any trials are finished. So we either increase authorized again or rs..What happens if we reverse and delays or something worse happens? Well, what will happen if we are on the OTC and something adverse takes place? Where would you rather be if everything goes as planned? So I for one hope they make the move as the benefits of doing so outweigh a bloated OTC situation. Once again, I don't understand the "fear", so please express concerns...you should also take that list you presented and view how the institutional holdings change the dynamics.
gee, thanks for the update.
who is talking about RPE and Hemangioblast cells?
rumit/louisa ..re: WARF/ACT license
phone reply and e-mail from WARF saying they cannot comment. No response from ACT.
WARF is not able to comment on the existence of a license agreement with ACT. Please contact the company for more information. Thanks and hope you have a pleasant weekend.
Sincerely,
Andrew DeTienne
Stem Cell Licensing Manager
Wisconsin Alumni Research Foundation
614 Walnut Street
Madison, WI 53726
PO Box 7365
Madison, WI 53707-7365
Office - (608)262-7859
Fax - (608)262-7859
Email - adetienne@warf.org
Web - www.warf.org
no doubt that is part of it, it always is. Add that in to the options the debtholders have:
PLAN OF DISTRIBUTION
Each selling stockholder and any of its pledgees, assignees and successors-in-interest may, from time to time, sell any or all of its shares of common stock on the Over-the-Counter Bulletin Board or any other stock exchange, market or trading facility on which our shares are traded or in private transactions. These sales may be at fixed or negotiated prices. A selling stockholder may use any one or more of the following methods when selling shares:
· ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers;
· block trades in which the broker-dealer will attempt to sell the shares as agent but may position and resell a portion of the block as principal to facilitate the transaction;
· purchases by a broker-dealer as principal and resale by the broker-dealer for its account;
· an exchange distribution in accordance with the rules of the applicable exchange;
· privately negotiated transactions;
· settlement of short sales entered into after the effective date of the registration statement of which this prospectus is a part;
· broker-dealers may agree with the selling stockholders to sell a specified number of such shares at a stipulated price per share;
· Through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise;
· a combination of any such methods of sale; or
Any other method permitted pursuant to applicable law.
Well, the same gang from the 2009 run are posting the same now as back then. I guess I simply don't understand. In 2009 the Company wrote on the blackboard in big letters for all to see...260MM shares added to float....this time around another big float increase happened and yet the same excuses and theories.. I honestly don't get how the messages the company sent starting with the DEC 27 8K were once again ignored by many. As I said prior, Ground Hog Day...
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=58412055
well sure it is, that has always been the excuse, hasn't it?
Depending on the stage of the study, doctors will inject 50,000 to 200,000 RPE cells into patients' eyes
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=58323181
Advanced Cell’s trial will start by treating a single patient with an injection of 50,000 cells, Lanza said. If no safety problems are seen, two more patients will receive the same dosage, he said. Subsequent patients will get higher doses to find the most effective safe therapy, Lanza said. http://investorshub.advfn.com/boards/read_msg.aspx?message_id=58357040
"Dry AMD is the leading cause of blindness in individuals over the age of 55," stated Robert Lanza, MD, ACT's Chief Scientific Officer. "As the population ages, the incidence of AMD is expected to double over the next 20 years, further exacerbating this unmet medical need. Using our clinical-grade hESC lines, we are able to generate a virtually unlimited and reproducible supply of healthy RPE cells. Because only a small number of cells (50-200K) are needed to treat each patient, manufacturing and distribution of the therapeutic product is scalable with many similarities to the drug businesses that pharmaceutical companies understand well.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=58405022
Stephen Price, SVP
Well, it didn't take long for Rabin to place a buddy into the SVP role.(did we need one?) Maybe at some point, with a new CEO, we can eventually have a BOD group and management not involved with financial groups profiting from ACT.
Rabin-Price..from Cais Internet to Price consulting(money for financing) in 2004-2205 with ACT to both being involved with PDPI who are a current debtholder.
Cosulting Agreement with ACT..April 28th, 2005
http://www.sec.gov/Archives/edgar/data/1140098/000110465905024999/a05-8588_1ex10d50d1.htm
document signed,
Price Consulting LLC (dba Green Mountain Finance)
By:Stephen Price Managing Director
Both Price and Rabin involved with PDPI
PDPI-Rabin..1/3 owwner
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=57788027&txt2find=PDPI
(PDPI+Green Mountain Finance)
a debenture in the principal amount of $250,000 to Pierce Atwood LLP in order to satisfy certain outstanding payables owed by the Company, and (iv) a debenture in the principal amount of $61,000 to PDPI, LLC in order to satisfy certain outstanding payables owed by the Company to one of their partners (Green Mountain Finance LLC). The debentures and warrants described above contained the same terms and conditions as those issued to the investors in the 2008 financing.
http://google.brand.edgar-online.com/EFX_dll/EDGARpro.dll?FetchFilingHtmlSection1?SectionID=6043936-231528-237848&SessionID=ThuSHC9JmyZQEA7
From Rabins profile:CAIS INTERNET
" Before joining CIBC, Mr. Rabin served in an operating capacity at a broadband services company when he was Chief Strategy Officer of CAIS Internet, Inc."
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=57766163&txt2find=CAIS|Internet
Stephen Price+ CAIS INTERNET
SEC proceedings:
http://www.sec.gov/litigation/admin/34-48485.htm