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Warning to retail investors. When a company does a reverse split, say 1,000 to 1. The total capitalization of the business is not changed. Before a 1000x reverse 1.9 billion shares times .09 per share = $171 million. 1.9 million shares x $90 a share = $171 million.
Fundamental Issue with ACTC is not the size of the shares. That's simply a mathmatical nicety.
The real issue is: How can ACTC afford to rent the UCLA, Oregon and all the other labs/operating rooms in order to inject their patients' eyes. It is hugely costly and Rabin needs a ton of cash to power through these trials. The dirty secret that NONE on this board is considering is what damage will Rabin due to stockholders if he needs $50 million in new cash for the next year?
Let's just say he does get a 1000x reverse split. $50 million against $171 in capitalization is a 29% dilution. Multiply the stock price after the reverse by the reciprocal = $90 x .71 = $64.61. This is a 25.39/90 capital loss or 28.2%.
Anyway you slice it, you have lost 28% of your portfolio value if all else is held the same. Your ownly saving grace is... will Rabin use the proceeds carefully and get the frigging trials complete in a timely manner????? What will the Street give back as value to the Company? And really, how long will it take to regain the former valuation?
Realize that this is probably not to terribly close to reality. But, it does demonstrate why stock shares fall when companies due a reverse split .... It is the cash required amount that dwarves the rest of the share price valuation as dilution will be very heavy.
ES1 and other board members. Do NOT use technical analysis to give yourself a false sense of confidence. This is an extremely volatile biotech that is extremely small and extremely early stage. The stock price IS NOT a function of fundamental analysis. It is a function of the demand for shares as sort of a popularity contest and nothing more.
The fact of the matter is that the only avenue for significant amounts of incoming cash is to issue HUGE amount of shares. That is, dilution. Realize, with successful trial data being released, the Company will use that time period to issue shares. Note, they just received approval for almost a doubling of shares outstanding.
The correct point of view is not to study the value of your shares. Instead, look at how much in terms of dollars you are willing to risk in order to participate in the eventual success of trials. Only then will we have a bona fide chance in reaching shareholder profits.
Am I suggesting that folks go into paralysis by analysis? No. ACTC.OB is the right product in a HUGE worldwide need. But, it will take significantly more cash before these products start to get to market. And, it will take approvals by the FDA which is always a crapshoot.
While this stock will be volitile, it will take incredible patience in order to capitalize on this investment. Good luck.
How many eyes have now been injected by ACTC? I count 3. Am I missing something?
Sorry to be behind the curve on what's happening.
The stock has shot up this past week on 2 whispers, IMHO. (1) The CEO is enthusiastic about the Company given the success of the lower number of stemcells that have produced a remarkable result. No numbers or qualities out there, yet. He's simply smiling like the proverbial Cheshire Cat and disappearing with the huge smile hanging around! That's call building confidence.
Secondly, the whispers are about how many they will be injecting at a time for the rest of the Phase I/II trial. Recall they were talking about the cohorts specifically arranged by increasing dosages of stemcells. I'm hearing that they might inject a whole cohort at a time which would collapse the time to completion radically. Further, this has changed the landscape as to how quickly ACTC.OB can get to their next level of Trials... AND HOW LONG SUCH A TRIAL WOULD LAST!!! This is the hidden driver of value. This is the BIG KAHUNA in my humble opinion...
Therefore, to my fellow investors, if you have heard or read differently, please correct this analysis. We don't want unbridled optimism hear if it isn't merited. But, if you concur with this cocktail napkin commentary, please let me know.
Why is the above 2 whispers important beyond what I've already stated? You see the General Biotech Investor Market has been obsessed with the GERN complete retreat from their trials involving the nervous system. IMO, the Street was thinking that ACTC.OB would follow suit. As this breath of optimism continues to grow, the Company will continue to gain in value and in share price.
The Market also gave a thumbnail expectation as to when ACTC would be re-valued. It would be after painfully long trials. The whispers about the injection timing has the street aflutter.
Good luck.
Gastro, are you asking should we be worried when an investor buys or sells $25,000 to $30,000? Seriously? My friend, I'd start to worry when I see 25,000,000 shares start to be frequently sold. But even that pales in the real Wall Street marketplace where positions valued above a million bucks are a dime a dozen that change hands hourly.
Thus, I wouldn't worry about blocks of 250,000 shares coming or going. Rather, I'd focus on the science.
Why was the company up so much today?
I think in part because the Dendreon sales in the 4th quarter were up 16% above the general consensus. This immediately reminded the street that they had tremendously UNDERVALUED the entire biotech sector and would be missing out on huge profits with nice revenues created by successful biotechs.
To the degree that folks believe that ACTC will be successful, when another biotech is up, they feel good about investing in other, smaller biotechs. I call it the AMGEN factor. When folks feel good about AMGEN, the whole sector rises.
Good luck... and remember to buy low and sell high. Don't wait for another DNDN or AMGEN field day to buy some more shares in ACTC.
Gastro and others ... could the market traders have hoped for a take out when the former CEO unexpectedly died? When I read that the Company had so few directors and managers, I too thought the Company would seek a buyer to provide experienced management. Or at least that was a reasonable thought at the time.
Seems to me there was NOTHING fundamental about that share price other than hype. The stock had rallied from $0.04 a share or almost 7 fold at that point and most of it came on one days' trade.
So, if you are trying to salve wounds of the loss of portfolio paper profit, and do so by some sort of fundamental valuation, you aren't going to find it in ACTC land. Until the Phase I/II results are in or even a Phase II/III trial, this is a beauty contest and not a stock valuation.
You best not look to the day to day turbulance in the shares. It will give you sea-sickness.
I wish all of your a Merry Christmas/Chanukah/holiday that you might celebrate. I know it has been a challenge for each of us this past year. We aren't crystal ball experts and knowing when to buy ACTC has been rather crazy.
I hope that you can get your mind off of your portfolio for a few days and find recreation and rest. At our house we'll be having our Grandkids over in few hours to make for a loud time. And we'll have football on the tube.
The stock will gradually regain traction. Not a robust up or down but a slow and steady upward trend with quarterly improvements. Just keep your wits about you and don't gamble. This just could be the very best stock to own for the next 5 years.
Regards to all.
There is NO valuation model to be made at this point for ACTC. It is so doggone early in the process, a valuation is a figment of the author's imagination.
Let's review the purpose for a model. It is to best predict the future so that you can make a money decision. I'd rather use tea leaves or throw dice at this point. Why? Because if it achieves anything close to reality 3 or 4 years from now, the author is just lucky. There's no financial analysis of the potential market translated to ACTC now.
This is NOT to be negative towards ACTC. Not in the least. The time for establishing a financial model for ACTC will be much later and when there is a better than 50% they'll approve the initial products. That would begin with the commencement of the Phase III trial. We would have to listen to management as to which market segments the Company will approach based upon feedback from their clinicians throughout the US.
Then we could start to envision volumes and perhaps even identify pricing and then the cost of a roll out. Heck, who knows what the price of such a therapy would be acceptable in the market?
But this is way to premature to even consider such an effort.
At this point, the very best thing you can do with ACTC is to hope for patience and patients. Realistically, the best you can hope for is to take a small position and not expect to sell for at least 2 years from now. I would not want to turn this investment opportunity into a gambling exercise for the unknowing.
Welcome aboard, Jmasdoc. The market analysis is extremely compelling. There are so many diseases that might be addressed by this scientific team over the next 5 years, ACTC could be THE most sought after research lab in the world. It would be for biotech research the way Bell Labs was for the communications industry for 75 years.
But, let me help you understand the lay of the land. The FDA controls the insurability of any patient receiving any prescription in the USA. If they don't approve the drug, it is out of pocket for the treatment. In fact the FDA has the ability to shut down companies that are providing surgical solutions privately if their procedures/drugs have not been approved by them.
So, pre-approval, companies such as ACTC have to follow the procedures/protocol necessary to get a new drug application approved by the FDA. These are typically in 3 levels of trials. The first is very small with under a few dozen patients where the drug is carefully tested for human tolerance. A drug company coming out of the lab has to show significant results using lab animals to be able to convince the FDA that there is no significant health risk. This then is called a Phase I trial. ACTC has 2 trial on-going now (call Phase I/II) where they are injecting their patients' eyes to both stop the progression of adult macular degeneration and juvenile macular degeneration (Stargart's desease). These are leading causes of blindness in both populations.
The trial is very simple, the doctors will inject one eye of each patient into the RPE channel with stemcells that will help regrow the communication capabilities of the eye and nerve ways into the brain. Then after about 6 weeks the doctors will test the patient for eyesight improvement. So far so good it seems. An independent team will then confirm the findings which will take a few weeks.
Actc is on the record saying that they hope these 2 Phase I/II trials will be completed in the first half of 2012.
The next step will be a Phase II trial where different doctors in different hospitals will see if they can at least duplicate the success of the Phase I/II trial. This trial should have nearly 100 patients and be distributed across the country in major eye surgical centers. This could take at least 1.5 years and probably closer to 2 years. This would take the completion date into 2014.
Lastly the Phase III trial which will be with several 100 patients will be for efficacy. The trial will measure specific levels of accuity obtained through the injection of stemcells experience by the patient. This is at least a multi-year effort.
Each time you complete a phase, you have to interact with the FDA which is an frustratingly slow process. Just the review of a Phase III trial can be as long as 6 months IF the trial is expedited and given fast track status.
I guess you can infer my basic premise. We are more than a few years away from FDA approval.
Thus, we have to temper our expectations for this powerful potential with the realities of medical trials and testing. Don't let folks that don't understand the intricacies of how the FDA operates try to convince you that this is a slam bam deal. This is a very slow and very long process.
I am hoping that the time lengths can be condensed, but that is wishful thinking on my part. If you make an investment in ACTC, realize that you are in a very long term investment period before you will realize significant stock appreciation. Thus the multiples that lead to billions of dollars of valuations are off into the distant mist. And given the length of time to get there, professional analysts won't begin to cover ACTC for a couple more years.
Good luck.
Another tip on what I use for a tool. It is rather simple minded but it is rather powerful over time.
I look at a 6 month graph and focus in on the bottom of each swing that's greater than a 2 week trend. I look at volumes during such periods.
And here's the kicker. Over a 5 or 10 day period as it hits the bottom, I'll take an average volume of that dip. If the average volume of the dip increases only to be followed by a recovery, a sell off but with more volume, then I know without question that someone big is accummulating on the dips.
If the bottom starts to rise and there's a quiet accummulation going on, I'll increase my shares owned. I know that the flow of the stock price will be supported by larger players such as funds expanding their ownership OR new players taking significant positions.
This is NOT ment to over whelm you with a bunch of analytical poop. It is just a quick and dirty technique to figure out if the big boys are taking positions into the shares before the market figures it out.
Thus, I gain more knowledge with dips and volumes than other periods of trading.
Investing vs. Trading. There is a huge difference. When I invest in a biotech, I look first at the potential multiple. If I'm thinking about investing during the first Phase I trial, I am expecting a very large multiple down the road to compensate me for my risk and the long term to expected pay off. But, this dictates that I've done extensive due diligence on the products under trial. I've looked at difficulty of the technology to be introduced, the complexity of the drug (or creation of the stem cells), the ability to withstand competitive challenges and the likelihood to be able to manage the process (quality of scientists).
I am very interested in public pronouncements for the past several years and clarity of information released. I am very interested in the continuity of management under adverse situations.
I do NOT try to forecast future cashflows in such an early stage investment. I anticipate several needed fundings to keep the business running. However, I am very concerned when I see shares being printed as if it is a 3rd World Currency.
In fact, I don't read the boards each day. I do a quick scan of headlines on Yahoo.com for my portfolio. If I see a 5% up or down, I dig down further.
I do look at the chart to see trends. I like the 6 month and 2 year charts.
But, that's about it. The day to day fluctuations are beyond my comprehension. I tune out the trolls very quickly as they tend to publish at a much greater rate than valuable posters. I'm not in this for popularity or to be viewed as a stock maven. I'm in this to make money.
I do appreciate those of you with good intentions and good hearts that are so eager to share information. Thank you.
I just think that the art of investing gets short shriff with all the day to day traders hovering around stock boards.
$6 Billion?
Sorry to force reality on retail shareholders. This Company is at least 5 years away from such a stock evaluation.
Reality is this. The astronomical valuations folks in the biotech patch like to spew are tied to a different era of stock investing... BEFORE October of 2007 and thus before the Financial Panic / crash.
There is just not a lot of disposable cash flow in and throughout Wall Street. Every month the market goes sideways, the cash falls. Why? Salaries and office expense have to be paid from such little real profit. And there's a huge number of office types that make way too much money for the cash generated throughout the street.
This is forcing the Street to re-value all shares. It is forcing a much higher discount on future "possible" cashflows. Why? Because it is darn near impossible to replace cashflow from blown projects.
Here are some basics. If a biotech gets sponsorship, the pre-trial value can grow as high as $300 million (RARE) in capitalization. If within 6 months of likely FDA approval (Company announces positive data from a Phase III tria), The Street will increase the Company's value to $500 million to $700 million. Upon commercialization, the street will push it up to a billion if the projected sales will achieve over $300 million after 1 year.
When the run-rate of sales moves up to $87 million a month, the street will begin to expand the sales multiple up to 6x sales. And this is where the $5 Billion starts to appear.
But, any premium on a small little buy out is going to be very hard to achieve. Even a buyout premium over 50% could cause the acquiring CEO his job if the acquisition doesn't pan out.
No. The world has changed dramatically in 4 years on Wall Street since the Financial Panic of 2008/7.
This is the right way to move forward on medical science breakthroughs. Dr. Schwartz knows much more about the science underneath the outcomes and would have couched his language with "remains to be seen" if there were any doubts left in his mind. Researchers are only human. They want to contribute to this modern miracle.
So, the Good Doctor has joined the ACTC parade and that is really important. This will translate into other prestigious facilities quickly signing up and will make cost certain the future cohorts trials expenses.
Bottomline, we avoided a real showstopper if the lab doing the trial was disappointed with results. In fact now, we have an ENTHUSIASTIC LAB DIRECTOR SUPPORTING THE TRIAL.
Many thank yous to Louise and Hort for their help in getting this important step documented on the board.
Sometimes expected value is very hard to ascribe, let alone used to compare and contrast with other companies. The practice of comparasons is as old as man. Why not compare?
But, and I say this with humility, it takes an almost soothsayer at times to understand the future value of a biotech that is several months if not years away from a drug approval.
I don't blame Wall Street for stepping back from ACTC. While the product is extremely interesting and poised to fill an unmet medical need, you do have to worry about stemcells and politics. And yes, ACTC does have an answer for stemcell research with their blastomere reasearch, the answer seems to be overwhelmed by the political in-fighting and shouting by folks not in the know.
The Street will therefore act with their hands in their pockets until a. the political climate accepts ACTC's answer to stemcell research (I personally believe this is already happening as the more folks I talk to about their scientific breakthrus, the more people warm up to the drug) and b. the FDA accepts the infusion of stemcells into the human eye as safe and efficacious.
Draw what ever conclusions you want. It still gets us to the same place. $0.10 times 1.7 billion shares outstanding gives us a capitalization value of $170 million. Finish the Phase I/II trial successfully, and the shares will gain as the Street gives more credence to the infusions. Fund raise for $30 million, and THEN consider a reverse split. Perhaps 50 to 1.
Good luck.
Have a happy Thanksgiving Holiday, my friends. Thank you so much for your generous sharing of your insights, opinions and information. Perhaps in a year or so, we can add some significant investment returns to the above...
Thank you, Louisa. If you start out with a problematic goal, all your strategies just get you nearer to problems. The key to capital conservation is to start off with easier to master goals so that you will have quicker successes AND profits to fund the later trials. Then all your strategies get you closer to results.
I've seen too many CEO's promise the moon and deliver zip in the biotech patch. One of the reasons I invested with ACTC in the beginning is that the trials should be completed more quickly given the target within the eye.
We'll know fairly soon if this trial can be completed in multiple locations under different personnel. (of course the answer is a resounding YES!) But, this is to prove the point that this new procedure and use of stem cells is efficacious across a spectrum of facilities. Dr. Lanza will be spending the time instructing the teaching facilities the procedures and details and will be hands on with the results.
The Street denotes completion of Safety for a new drug by increasing the capitalization value of the Company. With a combined trial being a Phase I/II, this is more than Safety in just one clinic/hospital setting. It is testing the viability of the product in various settings not only for Safety on humans but is there clinical value. Note this is still not to the level of being efficacious. (That is from a full bodied, Phase III Trial in 2014 or 2015.) But, it is a broader test than straight forward safety.
Thus, the surprise would be the ease of results (the data results tightly repeat themselves between centers) at 5 or more major clinics across the country. That would allow Wall Street to vote with there wallets from the $275 million level up to $550 million or there abouts. If the results vary widely between centers, then ACTC will be locked into a full blown Phase II Trial (Perhaps 2 Phase II Trials.)
Warning to investors! DO NOT divide current shares into $550 million. We have to fund raise with additional shares at the conclusion of the Phase I/II. Those additional shares WILL in part gobble up the additional head room in the Street Value of ACTC. Thus, we're apt to get perhaps only about half of the additional, incremental value of ACTC with a successful Phase I/II. Perhaps as much as $0.12 per share more in street value, or Low $0.20s after fund raising.
The safety aspect is where the stemcells do not remain anchored in the RPE channel. That is, they get loose and move around within the eye. The reason for the 4 Cohorts is that the ACTC's scientists want to find the best number of cells injected for maximum advantage. But then as the cell numbers rises, the number of cells to remain in the RPE channel increases.
Thus, the safety aspect of the trial will continue until all 4 Cohorts have been completed and the data is evaluated for safety. At the same time, the scientists will be getting a leg up on understanding the effect of the number of cells with regards to vision improvement.
There will be no short cuts here. The only way the trial speeds up is if the number or patients getting the cells get shot more quickly and the turnaround is quicker. But, that's not likely.
Rabin said that he hoped the Phase I/II Trials would conclude by the middle of next year.
That may be optimistic. We'll have to see if the number of cells shot into the RPE channel becomes more cumbersome wrt safety as the numbers increase.
I want to commend Hanuman for his post. He is 100% correct. However, I am talking about 2 Phase III studies which are much, much larger and on a nationwide basis than a Phase I/II study. Typically, no journal will devote time/effort to a formal review to any study unless it is a Phase III, ready for FDA submission. They might allow a brief comment, but certainly very little detail.
The Journals I'm referring to, the really prestigious journal are in fact very firm on this point. If the phase III data is released elsewhere in a PR even by mistake, the presented study is viewed as tainted by the Journal and refused publication. Why?
First of all, prestigious Journals have limited numbers of pages. There is much competition for the space by many study submissions. Second rate studies get second rate status and fall to second level Journals for publication. If you fail to live up to their standards, then it makes it easy for them to pass on your analysis. Obviously with lesser Journals, it is harder to get a community consensus to support your study.
Secondly, prestigious Journals have an editorial board that reviews your study and they debate the science of your study. It can take a few months before they conclude a yea or nay behind your study. Obviously, if the study is accepted after their peer review, then authors of they will slot you into a publication. But, the timing might be delayed as you could be queued up against previously submitted studies.
Thirdly, this does not end the analysis of the data and the results of the study. Upon appearance in a Journal, the general scientific/medical community can then make comment. Such comments can swing the general sentiment of the community for or against the study.
Only then, when the FDA sees the general sentiment of the study that it is indeed relevant and important to pushing forward the benefits will their statisticians seriously take up the NDA for review. Without the general public of scientists and medical doctors behind the application, they will simply drag their feet and eventually decide the fate of the application.
However with a strong public sentiment, the FDA will then move forward. BUT even in a perfect world, they have 6 long months from the submission of a study to a PDUFA date if they've granted fast track status. If the FDA doesn't, they can take up to a year to decide the fate of the application.
There are no overnight successes when it comes to the FDA.
Understanding the approval process is crucial to your biotech investment strategy. Failure to understand the steps will mean that you expectations for share price increases will be completely frustrated.
Rabin is counting on a logarithmic rise in ACT's stock price with a successful conclusion to the current Phase I trials. He alluded to it in the context of the next significant fund raising effort. He strongly wants to right the ship.
Fine and good.
But, I'm afraid the Board of Directors is going to need to understand that this Company has champagne tastes but has to be on a beer budget. This Company can't be all things to all people in so many different products or they will end up with no products. They have a tremendous stable of boni fide homerun products because they have a hugely successful Science Leader (Lanza) and now Board (Langer). So, how to get cash without selling the crown jewels? And which products will be considered the crown jewels?
Very good luck to CEO Rabin. He's going to need it.
Take aways from the conference call.
1. "we have enough cash on hand to complete the phase I trials without having to go back to the capital markets."
2. Rabin expects the Phase I trials to be completed in the First 6 months of 2012.
3. 4th Qtr cash utilization will be about the same as 3rd Qtr.
4. Board of Directors will meet in Dec to decide on strategic direction. That Rabin has beefed up the board to get experienced hands to help direct ACT. They will have a lot on their plate beside science. Funding. Do they separate out the various blood products? Should they go into China with Joint Ventures objectives? How can the company build the manufacturing from a small situation to a very large commercialization.
5. Clinical progress made. Will inject 5 more patients by year end. 4 in new prestigious centers in the US and 1 in London. They want the additional centers as participants in completing the initial cohort.
6. Will report info to investors as part of a larger Scientific and General/Media strategy. They will observe the highest scientific standards using a methodical approach. No info will be released haphazardly.
7. China -- huge opportunities ahead in China. Toured one facility where they treat 4,000 patients a day. Want a joint venture as the partner will supply the capital for the Chinese trials and they will share profits. Will choose from 3 groups. Mentioned that they groups are interested in the blood platelets product. Mentioned that they are working with only groups that will safeguard their technology and research.
8. Explained that the warrant liabilities were cashless but dilutive.
Update on Clinical Activity slated for Weds. afternoon. Now that's a great idea. I am looking forward to the news. Hopefully it will be very positive and forward looking. I wish all of the ACTC employees and shareholders luck with this new info.
Thanks Rocky for the post!
"...people get out of ACTC..." Said with fervor.
I completely disagree with you. Here is why. When I've bought shares, I buy so on my own due diligence. I won't be steered by your emotionalism and ranting. But, I also won't be manipulated into buying more shares on a gambler's hunch. Yes, there's dilution ahead. So what? All biotechs have to go to that phase when they don't have revenues at hand. Are you a beginner and haven't realized this necessity?
This is about investing in SCIENCE. Cutting edge science. This is about the human eye diseases and how to begin the process of taking back some ability for the eye to function normally... out of the darkened world of macular degeneration. Some have noted that this could be a $30 billion buck market. I don't know. Perhaps. But, I'll leave that to the folks that have a much clearer eye on the need.
This is a very early stage biotech stock. There will be ups and downs. I do not encourage traders in this stock because it is still on the over-the-counter market and you can't purchase Options insurance.
Yes, there will be market makers doing the evil deeds of their largest patrons like selling short. So what? If this therapy can finally get to commericalization in 2015, it will be a God-send to the patients. And that is my goal. Make money but more importantly, help mankind by endorsing new therapies.
I won't waste further expression here on your knee jerk suggestions. If you lose money on ACTC, it is because you didn't hold on long enough...
This stock is going to require Patience and Patients.
Cordially yours,
F
You don't have a rudimentary sense of history for this company. The stock price did break a penny intraday a few years back. This Company simply survived that catastrophe. Period. End of Story. You are behaving as if this Company's execs had a choice.
Listen, and listen carefully. Since 2007, the world of finance has changed. The World's capital had an incredible fall off of a cliff. $40 TRILLION worth of capital went poof! That included the money being tossed into the biotech sector. Couple that simple fact and the really, really tough anti-stemcell politics of the Bush Years and you have a perfect storm visited upon this stock.
Instead of belly aching about the stock price, you should do some hard core due diligence about what this company has gone through. Then take off those 1995 rose petal glasses and wake up to the reality of the stock market world of 2011.
Hedge funds are funding themselves by shorting small OTC and NASDAQ companies. All because the world of finance really did change with the 2007 - 2009 financial panic and aftermath. They have (with the tacit approval of the SEC) creamed one company after another. ACTC is not unique in this far reaching problem.
ACTC will be the target of shorting until they bring a product to market and it cash flows. Until then, it is they and not management strategies that are holding back the stock. Management is just trying to keep this stock alive.
Oh and their salaries... that so many here are so jealous of... wake up. If you want to keep competent management, that's the reality. You can hire a real random group of lousy managers for $140,000 a year. And you'll never get to where you want to be as an investor because those types of managers have no ability to bring quality products to market.
Are there any T. Edisons within ACTC??? You see, I love their scientific breakthroughs. They are world changing if someone can simply command the approval process, the funding process and the commercialization process and get these products to market.
What I'm saying is that while Edison may have been a great inventor, his genius truly was his ability to get so many new products to the average consumer. Where as the science has indeed take very large steps forward out of the mice labs with ACTC, the process is slow and tedious in this generation to get anything to the consumer.
This is where a new general, be it Lanza or Rabin or ?????, steps forward to maximize value for the investors. It will take an extraordinary leader to harness the profit making potential with so many avenues to choose from. And with each golden goose pursued, ACTC will attract extremely envious competitors that will want to grab her for cents on the dollar.
I am extremely pleased with the rising stock price this week. I hope that there will be a continuation of an upward Melting of the stock price...
GLTA.
Jonny Boy. This sounds like your first foray into the biotech patch. That's ok in my book. You have to start somewhere. Others are in the same boat. It takes awhile to learn the ins/outs of biotech investing.
1. The FDA has a long and winding road for any biotech or pharmaceutical company that seeks approval for a biologics license. This includes drug trial data sets, how to run them, how to report data and even the times it takes to deliver the data and how long the FDA has to make a decision. (ed. note.: we are just starting down this road with ACTC. We have a very, very long road ahead that's full of pot holes.)
2. The FDA will not accept your application if you have communicated to the public about your data. Period. End of Story. This is a very difficult rule that most investors don't get. It works this way, if the data is tainted by the Company, it won't come out until the FDA rejects the application. If a company goes out to the public and purposely creates a mob scene to pressure FDA personnel by saying how great is their data is with specifics, they would then turn the approval process into a political one and not a scientific one. Thus, if the Company even hints of their success or failure of data before applying to the FDA with their data in hand, the FDA will slap down the company application and tell them to go away and NOT ACCEPT the trial's results. The US Court System has adjudicated this point and agreed with the FDA on this point.
3. And the rigorous rules don't begin or end there. Are you aware that biotech companies sometimes wait months and months on the trial structure and what would be considered success? That is, the trial design is established jointly with the FDA and is recorded in their working papers and stored waiting for the data to be completed. Companies can't change the design willy-nilly because they will be accused of data mining.
When the time comes, you can submit your data and everything else required of the application process. But, the real evaluation only comes when you have filled in the FDA's trial database software and the FDA has run their statistical models. Many, many Company's trials come undone during this step because they have not gotten Full FDA approval on their trials.
Example: Arena Pharmaceutical's phase III applications blew up when the FDA's panel of experts rejected their application for not addressing cancer causing molecules in lab rats associated with their product ... which occured a full 5 years earlier. The FDA mentioned it in passing but gave the company a go-ahead to move into a phase I trial. Yet, when they concluded all the next 5 years of work, they submitted their data, their write ups to the FDA. The FDA called for a panel of experts. One of the experts knew of the cancer issue and came back to that single point and asked, "well, how did you fix this problem?" It didn't matter that the human dosage would have to be about 200 times less than the rats dosage. What mattered was that the Company had to pull back their application and deal with their molecule causing cancer in lab rats.
4. My point is urgent and straight forward to all folks investing in ACTC. You need to understand the environment of biotech investing (i.e. rules laid out by the FDA) if you want to succeed in this sector of the marketplace. This requires some homework on your part. I hesitate to say that you need to know all the ins and outs because that's a fools' errand. Just to see that you can't buck the FDA system is a good start. Their procedures are out on the internet. Google them. Then, Google what must a company do to have a successful phase I. And then a Phase II. You'll be surprised how specific the rules will be.
Sorry to be so pedantic and long winded here. We simply have a very, very long road ahead.
ACTC has a great deal going for it. It does have cash for about a year. It does have lines of credit (I believe) to a degree untapped. And, it has an incredible array of products in their labs. The shorts have forgotten painful lessons on overshorting companies with such an array of choices on how to walk to commercialization. They have over played their reasons for selling ACTC in my opinion.
Sometimes you simply have to wait for the emotionalism to be done with and in this case the short side of the market. This stock will bounce back into the teens. We'll see a big bounce once the lawyers for the warrant holders and the Company have a meeting of their minds and finally agree on parameters for doing a deal.
No one wants to kill the golden goose, especially the warrant holders. They ALL showed up with their hands out as soon as it appeared that the Phase I/II was going TO WORK. Remember that. It is as good as a buy signal as you will get.
Now, my heart goes out to those of you that loaded up already and simply can't buy shares below $0.10. Just hang loose. This Company's science will power the stock price forward when all this monkey business is completed.
And, if you do have some dry powder, why not start averaging in a position in the single digits?
JB, where would the researchers get their stemcells?
Are you aware of any of the lengthy research and patents on the research by ACTC? Are you aware that Lanza IS the #1 scientist in the world for this sort of scientific breakthroughs?
So, on the contrary, just any researcher won't be able to get their hands on the stemcells and the patents protect the utilization of them within the RPE channel.
The issue IS not the science or competition within the space. The competition is from other therapies in trial utilizing a different method of action.
To that I say, great. The patients will be the ones that benefit from competitive scientific approaches.
As far as investing in ACTC, average buy-ins are recommended. The current stock price is such a level. Now is a good time to start buying. Just don't toss all your investment dollars into the shares at any old price. The street is going to push the share price around for a few more months until Rabin gets agreement on the warrants price.
Please understand that the shorts want to make hay by turning this board upside down and get and keep a continual negative mood here. Don't buy into that. Don't measure yourself by the stock price until the results of the complete phase I/II are known. Grousing about the dilution, the lack of Corporate Development with partners, and how slow the trials seem to take, all of this points back to the poster that has no clue what he/she is getting into when investing in micro cap biotechs. Don't be that rusty gate.
This stock is strictly a beauty contest at this point. Without a measureable revenue stream in the next 6 months, the stock can literally be any price a really big player wants it to be. To be successful in ACTC, your capital should be framed into a 5 year window. That's how long it will take for this company to finally get to commercialization from here. That is, unless the FDA gives ACTC a miracle short cut to approval. And, this might be the case... BUT DON'T GAMBLE ON THIS OCCURING.
Further, partnerships might show up and cause a huge upside for investors. These ARE not the sorts of reasons to invest because they occur when they occur and are out of our control. These are simply reasons to speculate/gamble in ACTC.
Grousing each day about your paper gain or loss is ok but, over time, you'll be pulling your hair out. Again, look to key events ahead and pattern your investing prior to the events depending upon your point of view.
But, we are not going to know the results of the Phase I/II until the end of next year.
Patients and patience is a common theme for folks to follow upon investing in this biotech.
Good luck.
No, I don't consider folks here bashers at all. You folks are passionate investors that want this therapy/scientific breakthru to reach the market so that folks with this horrid disease can purchase it and recover their vision. That is an extremely noble idea and worthy of investment.
This will be a fantastic investment if you can stand the near term heat. It's just that so many of us look at the stock price daily and say to ourselves we're goats or heroes. This sort of biotech investing doesn't work that way. Not in the least. Don't reward/sanction yourself daily due to the stock price.
There will be days like yesterday and today where the short side of the market will take advantage of the retail investors and try to scare them into submission and selling their positions. Keep your eyes on the horizon during times like these. No matter how screwed up the near term finances might seem, the shorts can't erase the scientific breakthroughs not the need for the products.
Just be careful from here forward not to risk more capital than you can stomach for the long run.
That said, from here forward we're getting closer to where I think it could be advantageous to increase positions. But, don't expect a tooth fairy to show up tonight and leave quarters under your pillow.
Thank you, Spetty, for your insights.
Rocky, et al... here's a problem for ACTC to resolve. 380 million more shares will take the shares issued up to nearly 2.1 billion shares. On a base of 1.75 billion that represents dilution of common shareholder interests of nearly 20%. This means that the share price will receive a 20% haircut cateris parabis. If the pre-announced share price is .14 cents, the post announced share price would drop to 0.112 cents.
Of course the stock price will move around quite a bit until a judge makes a judgment. But, if it continues to go against ACTC, this simple explanation shows the potential downside.
And, the shorts will try to make hay from this potential order being affirmed by a judge.
Paulness... the system is the system, unfortunately. Why? Because the FDA protects itself. No info to shareholders except under very, very, very strict provisions. Like when a trial has been completed... you may say the trial is completed. But you can't colorize the data until after the write up has been completed, sent to the FDA, the FDA accepts the write up and made their decision. Then you can add color. But, you may not share actual data for it is confidential. You may only share statistical inference.
Actual data colorization can be made after a successful phase III trial in a Peer-Reviewed Journal. The data can then be compared to a placebo group and/or other treatments.
As there is no placebo comparison by definition to a phase I/II, we won't be able to pound numbers and create a well thought through analysis.
Thus, Paulness and others, there will be no one telling you what the risk/return quotient will be for the time being. Let me conclude with a generalization. ACTC is extremely high risk as there's no guarantee that their therapy will eventually be successful and approved by the FDA. This is a very high risk investment that could lead to dramatic profits or losses.
If the board was forced to pass a unanamous consent to borrow/enter into a liability with any other party, it becomes not strictly a Caldwell problem. The kicker here is we don't know if the Board of Directors signed such a consent. With the voir dire (let the facts come out)stage of any trial, such a document has been signed or not. All the Caldwell Estate has to do is flash such a document at the Judge and he won't allow their shares to be placed in escrow.
PRs... and the stock price.
I've said this before. If a PR of really good news comes out, it will raise the stock price, but then, for how long? Dr. Langer is exceptional news but now, it is slipping in importance to the question of cash burn. If ACTC truly wants to get a much higher valuation for its stock shares, Management (Rabin are you listening?) how to create value with its dormant Patents that could be either joint ventured out or outright sold.
But this would require Dr. Lanza to reduce his research horizon to the implementation of first things first. And this would be painful to the great researcher because it would limit his future endeavors.
Either ACTC must view itself as an R&D lab or a biotech that will roll out products to create cash flow. If it is forced to jump strictly into the R&D mode 6 months from now, Management wont be doing the choosing. It will be the funding guys.
Unfortunately, this is one of the huge traps for small biotechs... losing control of their operation because they focus too hard on the research and not on the necessity of creating cash flow.
Thus, the Street will return to this issue over and over and over again after absorbing unexpected great news.
WOW! Robert S. Langer is a stunning addition to ACTC's advisors. Congrats to all involved, esp. Dr. Lanza. Hopefully, he can help spot potholes from the research side of things before we get to them. This is incredibly prestigious.
Let's crawl before we run. That $30 billion buck market place sure smacks of blue sky at this point. I'll grant you that it is a huge Promise Land. Harry, I'd even love to quaff a few gulps of champagne with you upon approval.
Here's my point of view. It is a lot safer for newbies not to even think about that Promised Land at this point because it will lead to over investing and that's dangerous for the less experienced investors. I'd table any and ALL discussion of unmet medical needs until this Company is in a real Phase III trial with significant success demonstrated by the FDA accepting the results from both a Phase I/II trial.
Some here are unaware that the FDA has at times require 2 separate Phase III trials to prove efficacy. I'm just not certain what the regulatory hurdles will be ahead because this Company is only now getting traction for its first Phase I/II combo trial. I have seen in my own experience, the Medical/Academic Community typically remains skeptical until they see the results duplicated with a separate Phase III trial. It is the old adage... prove to us your success.
All I'm saying is we have a very long road ahead to get to the Promise Land. It is going to require exteme motivation by investors to hang in there with all the road's curves and bumps ahead.
I am not pessimistic at all. We just need to not oversell the benefits and then get blindsided by the costs. And, believe me, there will be major costs ahead.
The blind see? Not necessarily with ACTC. For the newbies, you need to dig a little deeper on your due diligence to understand the MOA, (the method of action) behind this combo trial. The purpose of this therapy is NOT to give those that are blinded by Macular Degeneration. It is to aide those on their way to blindness that do have some partial sight left.
The disease as I understand it is a progressive disease. It simply overwhelms the connectivity nerves between the rods and cones with the retinal nerves and eventually breaks the connection. By injecting the stem cells into the channel in front of the retina, it repairs that connection and improves eye sight where is was deteriorating. BUT, it can't repair the cones and the rods that atrophe after the retina connection has been completely broken. This therapy does NOT repair rods and cones in the eye.
So, please, do not sell this to yourselves/others as re-gaining sight for those poor souls that have completely lost their vision. Instead, understand that this therapy is going to be applied to those on their way to losing their sight.
Perhaps our researchers can eventually rebuild rods and cones within the eye. But, for the time being that is a long way off.
So the phrase, "there are people walking around in Asia and Europe that were blind that have regained their sight" is misleading and a dangerous overstatement of this therapy.
Why raise this? Because we will eventually have shorts trying to overstate the benefit and then slam the therapy as it "doesn't work". We need to be vigilent to accurately communicate among ourselves the benefits of this therapy.
Not a shock there, Rocky. These guys no longer have a congruent goal for ACTC as the common shareholder. This happens when you gift them too many shares. As they don't have any worries except taxes, they will be selling shares once a quarter for not only cash but taxes.
This is not how the common shareholder sees it. Being well below even $0.20 cents, you don't have options to cover your downside.
So, you are stuck in the hold and pray mode for anything that will re-value upward the shares.
But, the employees keep frittering away free shares... get used to it.