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The really big Institutional buying won't occur till the Market Cap is dramatically higher, probably at stock prices at $5. Institutions which formally are chartered not to invest in stocks below a certain market cap or stock price frequently do get in, but then they get out before the end of the quarter unless the price goes above their threashold by the end of the quarter. Institutions only report what they hold for over the end of a quarter if it hasn't been held for a full quarter or more. An institution buying in October can sell on December 31st and not report at all, or if they do report I won't show until Mid February. While computers would permit all this to be done instantaneously, the rules permit Institutions not to report until half way through the next quarter. By the time Investors know what's really happened the news could potentially be as much as 4.5 months old if an Institution made it's move on the first day of a quarter.
It's my belief that by the time AEZS is $8 it will probably be 50% of more Institutionally owned. While some of these shares may come from newly authorized share, the overwhelming majority will come from individual investors selling.
I believe those who'll make the most money on this stock are probably not currently invested in its. If Perifosine and AEZS-108 are both successful, don't be satisfied with a 10 banger, in a few years it could be a 100 banger or more.
Gary
Here's an excellent response to AF's article about the Phase II.
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_K/threadview?m=te&bn=10207&tid=88849&mid=-1&tof=1&rt=1&frt=1&off=1#-1
Gary
I know, but clearly FH has ignored us for years, I don't expect anything until he's willing to reveal all. Sadly in the Pinks this kind of attitude goes without punishment from regulatory authorities. If FH determines he wants CTKH to legitamately trade he can file years of data all at once and all is forgiven.
If you don't believe me, take a look at WHEN. I hadn't even heard of it, had another stock known as APPI that hadn't reported in years, suddenly they took the new name and symbol and filed years of financials all at once. It's not worth much either, but perhaps it's building something worth holding. They are working on biofuels from algae growth, it does work, we'll see if it's more economical then other ways of getting it. Personally I believe it's better then creating it from growing crops, but the price to really beat is doing it for less then petroleum out of the ground.
I cannot see selling either of these companies for the few dollars they'd bring. If something real is happening behind the scenes, at some point we'll learn what it is.
I did get rid of all the CEXI but note it's still trading, and they still believe they have a product worth selling.
Gary
Years ago there was all sorts of discussions about how Carbon Nanotubes were going to dominate the market in all sorts of applications, including virtually all flat panel displays. Since that time LED displays that use less power then LCD and far less then Plasma are dominating the top of the line market.
Is it possible that FH while selling some product is primarily still involved with development of CNT's and when these products are ready for the market he'll finally open up about what the company's been doing.
I'm not saying this is the case, just that if it's possible, one reason for going completely underground on what you're doing could be the secrecy required by the other companies you're working with in doing it.
It's still my belief that CNT's will replace all sorts of things from how processors are made to flat panel displays, perhaps that roll up, to electrical transmission lines that are smaller, stronger, and have far lower line losses. I haven't kept up with developments, but I do pay attention to scientific news in general and advancements in CNT's just seems to have dissappeared.
At this point, regardless of what happens, I cannot see selling at prices under a penny if there is a viable company here, and if it's not, it will never go much higher then the $.0002 we've seen recently.
Gary
Many seem to be blaming the ATM on Yahoo. I have no idea how many shares from the ATM are being sold. It would be my hope that ATM shares would be used largely for institutional sales where the MM's generally would have to accumulate shares to deliver large orders. I would prefer that, and not selling many at these prices at all, but I don't know how the ATM's being handled.
If as some suspect each time the price runs up a bit ATM shares are coming into play, it is thwarting the rallies. This too will pass, and good news eventually should move the stock dramatically.
I originally thought the ATM could be better then a discounted offering, but if it's constantly being used, it's hurting the price worse than a one time offering.
Gary
I certainly agree. Even with millions of shares I can't see selling at any time soon, even at significantly higher prices, if the company doesn't release a full financial disclosure.
I cannot understand what's going on in FH's mind, but at some point I believe we'll find there could be real equity here. Perhaps never a dollar, but a dime would be huge.
Gary
It's my belief that Phase III is being planned, and perhaps it can be without other events occurring, however, in the back of my mind I have to wonder, is the company in the final stages of negotiating a partnership for AEZS-108.
If AEZS is considering a single worldwide partner for AEZS-108, at this point in its development, over $100 million up front could be reasonable. Certainly it's not guaranteed, but less impressive drugs have brought in substantially more.
Of course AEZS may be thinking of taking it well into Phase III, at that point history has shown big Pharma's willing to pay billions, when they also take a position in the company. What's clear is that until something is announced, AEZS has choices.
If AEZS is certain of Perifosine approval next year, one choice could be to wait and try to keep AEZS-108 totally to themselves. This might be possible, but even with Perifosine Approval driving the stock price up substantially, it would still require substantial dilution. Why? Because even if earnings in the first few years reach $100M, the cost of an approved commercial production facility for AEZS-108 as well as the cost of establishing approvals, distribution and sales worldwide could easily go into the hundreds of millions, or even billions. Much of what's needed is already available at most big Pharma's. In many cases even the manufacturing can be an adaptation of an existing facility rather then starting from scratch.
My point is that economics probably still says AEZS will partner the drug, if not, they may contract for services. I.E. they won't go it alone. At some point something will happen. The question is, are they trying to make it happen now, where a partner will take charge of Phase III, or do they wait.
There is a huge benefit to doing it now. Trial size. While no doubt both AEZS or a partner can reach an agreement with the FDA on the trial protocol. Lets say for the sake of argument that 500 people are to be enrolled and the trial will be concluded after 350 events. Acting independently AEZS would probably be able to fund sufficient clinical sites to enrol 100 new patients a year. If median survival was in the 18 month range such a trial could take 7 years to run. Big Pharma on the other hand might fund sufficient clinical sites to enroll 500 patients in less than one year, the trial could be run in perhaps 3 years.
It's my belief that even though long term shareholders may earn more without a partner, the benefits of a partnership at this point in the drugs development are tremendous. The biggest benefit is that instead of having to devote most of the companies finances to the development of the drug, they suddenly have substantial funds available for creating other drugs.
Eventually when drugs like Perifosine, AEZS-108, Solorel, etc are bringing in $100's of millions in annual earning, AEZS would have the funds needed to take blockbuster potential drugs to conclusion themselves.
Why not partner Solorel? Because it's a niche drug. With a small manufacturing capability and the assistance of someone like Fed Ex or UPS, AEZS can probably meet worldwide demand for this product themselves. I believe Solorel can bring in $10's of millions in earnings on sales that perhaps go into $100's of millions. That's enough to be worthwhile doing, but not of interest to Big Pharma.
Gary
Forgot the link:
http://ih.advfn.com/p.php?pid=nmona&article=49026129
Gary
You're right, here's a like to the recent and upcoming presentation.
I think $2's easy if the market's stable, but it's hard to rise in a market that's falling and I'm uncertain that won't continue until we have a stronger degree of confidence in the economy recovering. It's unfortunate, but our Politicians are putting Party above Country in not compromising on policies which most American's would say are right for the time.
Personally I'm all for greatly cutting corporate taxes, while greatly increasing revenue from corporations. I know that makes no sense, until you lower the rates dramatically, but remove the loopholes that have many corporations paying nothing. I'm not saying all exemptions should be removed, but lets lower the rate dramatically, strike all the current laws, then revisit those exemptions where a strong enough case is made to do something, but in every case that something should assure some tax is paid.
Some of our biggest corporations with tremendous profits currently pay nothing, or extremely low rates. If I remember correctly GE for example earned $7 billion and paid no taxes. To my way of thinking they shouldn't pay $2+ billion, which they would if they paid at the full corporate tax rate, but a 10% tax rate would cost them $700 million, I believe they'd agree its a fair rate.
There is a risk in simplifying taxes and tax law, we'd be adding to the unemployment picture as so many accountants and tax attorneys wouldn't be needed. Product prices could probably come down as legal and accounting costs would come down and even after paying the taxes, earnings would go up.
Imagine what would happen if we said all the laws past by Congress could be no more than 50 pages double spaced 10 pt. type. I suspect we'd have laws that were easily understood and contained virtually no pork as it couldn't be hidden in thousands of pages. Congressment who wanted billions to build an International Airport somewhere no one flies to, cause it's in his district, would have to write and defend such a bill. I'm not saying the money shouldn't be spent, but instead of that airport, perhaps it ought to be spent building new highways, upgrading our power transmission, sewage systems, fresh water systems, etc. Imagine what would happen if when their is flooding along the Mississippi and a drought in Texas that we could pump some of the excess to where it was needed. While I doubt we could ever pump enough to avoid all floods, we could diminish their impact, especially if we started pumping well before flood stage was actually met.
I know the above won't happen, but there is so much good we could do if we put our mind to it, but what the heck, lets get another International Airport built somewhere in the middle of nowhere, perhaps in time a city will grow around it. It's what our Congressmen do for their district while other Congressmen get their support for building something else equally unneeded in their districts. It's the American Political Way.
Gary
I believe their are milestone payment with royalty increases at pre-established sales levels. What's important to remember is that royalties are normally based on sales, not a percentage of the earnings. It's said that earnings from most drugs sold are in the 20 to 30% range, the remainder going to the cost of production, distribution and sales of the drug. If this is essentially true, the royalty figure AEZS receives should be 50% or more of what KERX should earn at absolutely no expense. When you add milestone payments and the cost of the trials, such an arrangement is fair for both sides.
What's equally important is that AEZS has the rest of the world, and as I understand it, Europe has agreed to accept the data provided to the FDA for European Approval consideration. I'm uncertain that AEZS with a large part of its staff in Germany is considering handling Europe alone, or if they'll either partner or contract for certain services. What's important is that however Europe is handled, AEZS should see considerably higher earnings from European sales then in places where rights were established far earlier in the trial process.
If KERX is sold post approval there is little doubts the buyer might want to either acquire AEZS as well, or partner with them. Personally I much prefer a partnership, even one which the partner takes a major interest. I believe shareholders still have the potential of tremendous future growth even if a partner essentially takes control. A 15% to 30% interest in the company would provide substantial control of the company after drug approval. Why? Because with the higher prices that Approval will bring, AEZS will see Institutional Ownership greatly increased and the Institutions will follow the lead of a Big Pharma that has substantial ownership. While 15% might only assure a seat on the BOD, 30% would effectively give nearly complete control as to the direction the company takes, yet they still would effectively operate separately.
Gary
Joel,
I really didn't mean to ignore you, I've been out at Catalina for over a week and spending little time on the net.
As for the price, I can't say who's trying to keep it down but believe they can only do it so long. If whatever data's revealed and whatever news is forthcoming reinforces the likelihood of approvals from the NDA's which should be filed next year, you'll not see it at these prices ever again.
Of course when you're dealing with the FDA their may be delays, in fact I believe the price could be 5 to 10 times higher prior to an FDA decision and even a delay that experts believed would be under 2 years shouldn't get a retrenchment to these levels. Only an out and out failure in Perifosine could do that, and even then other trials could lead to its approval.
Solarel (AEZS-130) is currently viewed as a Niche product which certainly can help the price, but at least today it's not looked upon as a tremendous profit center. It's use could change that if a greater percentage of the general population was found to be HGH deficient. This should be the first time in history where the determination of HGH deficiency can be simply and accurately determined. If it's determined that more then expected have the problem, it's use could greatly expand and suddenly a Niche product could approach Blockbuster potential. I'm not suggesting this will happen, it will take years post approval to determine if more people are affected then currently thought, but if that's the case, it could become part of our physicals once, or perhaps a few times in our lives. I don't know what AEZS will make for each use of the drug, but if they earned just a dime and the drug was administered once a decade to everyone on the planet, we'd be wealthy beyond our wildest expectations from this drug alone. Please note, I didn't say they sold it for a dime, I said they earned a dime, clear profit after all costs were paid out including the salaries and bonuses of all at the company. I don't know if that means selling it for a dollar, or ten dollars, my point is, if the volume were that great, it doesn't need to be a treatment that costs thousands or more. How'd you like to get just a dime for every dog that gets a rabies shot.
Gary
NP,
Personally I look at all these drugs as tools an Oncologist ought to be allowed to use. The fact that some other drug achieved a higher percentage is meaningless if that drug won't help a particular patient the Oncologist is working with, and AEZS-108 or some other drug which had lower percentages would help.
I'm of the belief that any drug benefitting perhaps as low as 10% of the population where other drugs don't appear to work could prove itself worthy of FDA approval. More importantly, I believe Oncologists will find combinations of this and other drugs never in trials together which will prove far more effective then any of them used alone, or used in specifically approved FDA protocols.
Of course with my attitude the FDA ought to approve more drugs, perhaps some day they will. I think the best test for whether a drug should be approved or not would come from people asking if they'd want access to it if they were stricken with the cancer, and if all other approved drugs failed. Only 20+% recieving benefit may sound low to you, but it wouldn't if you were somewhere in that 20%.
Gart
I'm not suggesting that all the technical theories are bunk, but the period after the 4th of July and Labor Day is often referred to as the Summer Doldrum's when it comes to Biotech's, largely because of a general lack of news during this period. This year's probably far worse then the average because of so much negative economic information bringing down markets everywhere in the world.
It's not that AEZS has had no news, the conclusion of the Solorel trial, anticipation of the Phase III of Perifosine trial ending, top line data for both, and finally anticipated NDA filings are all newsworthy, but it's all news that's completely been expected. Much the same is true with most other biotechs, but DNDN's announcement of less then anticipated sales tanked both them, but to a greater degree the entire industry.
I don't know what it will take to straighten out the economic mess all over the world, or even here for that matter. I believe we'd make a big step forward if Politicians put Country ahead of Party and spoke with one another, rather then through one another. The next election will probably be one of the nastiest ever as the Democrats wage class warfare and the Republicans scream cut taxes. The truth I believe is, we need a little compromise.
It's true that cutting taxes on Corporations could create jobs, if they were paying taxes. To me it's logical to lower Corporate tax rates, but eliminate regulations that permit them to operate offshore, or hide all they're earning in loopholes we've provided them. 60 Minutes had several CEO's defending their actions as what's best for the shareholders, wish I could disagree, but it's our laws that permitted the likes of GE to earn something like $7 billion and pay zero taxes. I believe we'd take in far more money if the Corporate rate were lowered to perhaps 15%, but most, if not all the loopholes and subsidies they get were removed and companies doing business here paid taxes here.
On the other hand the Republican's insistance on maintaining all the benefits for the wealthiest of us, while others suffer with less all the time cannot fly with voters. Cutbacks by States, Cities, etc because of lower tax revenue effect all our lives with lessened services. Our wealthiest may not notice the decay as much, flying around in their jets or traveling in limos, but the rest of us feel the potholes, and we'll feel the pinch if Social Security or Medicare is cut dramatically, at least when we're at that age, which I am. One solution to extending the benefits would be to take the level where you continue to contribute to the fund dramatically higher, yes, you can call it a tax on the wealthy, but it's the same percentage the rest of us pay on all we earn.
If I had a choice, I'd vote for a Moderate Party that promised to put Country above Party and would kick all the current politicians out. While I'm a Democrat by affiliation, I'm sickened by both Parties actions and would openly support a Moderate party that's somewhere in the middle, but not the fringe parties attempted by the likes of Perot and others.
AEZS and other biotechs will eventually soar, or fail, based on news that's specific to the company, not the economy, or other biotechs. Right now the big news people want to hear is Top Line Data for Perifosine, which should come a month or so after they announce the completion of the trial, perhaps by years end, or early next year. We've been told that Top Line Data for Solorel should come this month, while hopefully it's good, they've said they'd file a NDA early next year, that's a hint, but understand, this is a drug which should earn them some money, but not a fortune. The real news is about Perifosine, about AEZS-108 after that, both these have blockbuster potential, as do other drugs that are years further out in development.
The Dow's down over 100, AEZS is down pennies again, when it was down 50 we were slightly up. The point is barring other news we are influenced greatly by the market. When good, or bad news comes in, it's not that the market has no influence, but the influence is diminished. I'd much rather see great news on an up market day, but regardless, the news will ultimately lead to approvals and approvals will lead to earnings, it's those earnings that eventually will dictate stock value, though it's always influenced by what's happen in and around it. Under the right conditions a company like AEZS with earnings could be valued at 30 to 50 times earning under the right conditions, however under other conditions it might be judged worth 10 times or less. The earnings multiple is dramatically effected by other influences, if optimism pervades, the higher figures certainly come into play, but if pessimism is seen in the market or company, the multiplier will clearly be lower. In the time I've been writing this paragraph the Dow's improved to down 80, and AEZS is down just a penny. Things just happen this way.
Gary
Joel,
At this point much depends on what the data tells Analysts and Investors. We may only get Top Line data from the trials prior to NDA filings, but if that Top Line information is extremely positive suggesting almost certain approval, the stock price could rise dramatically on that. On the other hand, if the Top Line info is solid, supporting the NDA filing, but if there still are questions in the minds of the experts as to whether approval is a sure thing, then the price gain may not be nearly as great, but I'd still expect a rise as the PFUDA date approaches.
In the initial case where approval is practically sure, the price prior to approval may not rise dramatically after approval as it's largely built into the price. On the other hand if approval is questionable, then when it occurs the price rises dramatically.
Of course approval is never really sure, and failure of a drug anticipating approval often provides tremendous opportunity when instead of approval you get delay. Look at companies like DCTH or DNDN, both have had delays in the approval process. DCTH will eventually probably get approved, DNDN obviously did, but the sales data recently disappointed and the stock's back to numbers not seen for months before approval. It's important to properly value what's being approved.
Solorel is a niche drug. The niche may grow if more people are found to have HGH problems then currently are anticipated. The company may make millions, or even tens of millions from the drug, but barring a miracle it's not a drug that will dramatically increase the share price.
Perifosine has tremendous potential IMHO. If over time several cancers gain approval for treatment with Perifosine, it could be a blockbuster drug many times over. If AEZS only had it in partnerships world wide, and if those partnerships royalties were just 10%, it could earn them hundreds of millions annually. Even if the O/S eventually exceed 100 million shares we're still speaking of dollars per share in earnings annually. If drugs like Solorel make enough money to offset other corporate expenses in developing other drugs, then the royalty and milestone earnings from a blockbuster can essentially be pure annualized earnings. With other drugs approaching approval I believe a company like AEZS warrants a P/E of 30, but much depends on market conditions. I like $$$'s in earnings with P/E's close to 30. Of course this all starts with approvals, note the plural, for real success a drug like Perifosine needs many of them, the first may be the most important, its earnings will fund many other trials and while not every trial it funds will be successful, each successful trial will dramatically add to those earnings.
It should be noted that only the first approval is needed for drug sales in any capacity. Once approved, drugs can be used off label for other applications, but if you want insurance to pay, their has to be some history of success. If Perifosine is approved say in Colon Cancer, if promising data is seen in say a Phase II in Prostate Cancer, a case can be made for its use and Insurance companies may pay. On the other hand if no data's been established for Prostate and either an Oncologist or patient was convinced it might help, it could be tried as long as someone was willing to pay for it. If successful it could add anecdotal information which can under the right circumstances gain approval or greatly speed the process.
Many investors get in before Pivotal Trials and out just before or after approval. Growth during this period can be tremendous, however, if a company has a large pipeline, and if the drugs approved have tremendous sales growth potential, the company may undergo tremendous growth for many years. I failed to buy AMGN in 1990 when it was about $15. When it split a couple years later I thought it had its run. It went on to split 3 other times that decade, a total of 48 to 1. Since that decade it's largely been dead money, but what a decade. I'm not saying that AEZS could have that big a decade, but looking at it's pipeline, with success in several bigger drugs, it could write the same sort of story if it's not bought out.
Gary
Joel,
While it's possible that Perifosine will end the trial this year, and the end of the trial for AEZS-130 has occured, don't rush the approval process. It takes substantial time post trial to fully understand the data and properly present an NDA, AEZS has clearly stated it will be early next year before their submission on Solorel (AEZS-130) much the same should be expected of KERX on completion of the Perifosine Phase III, so conclusion this year may still take well into next year for NDA submission.
Small biotechs generally partner drugs because they simply don't have the funding required to do everything properly themselves when it comes to testing, manufacture, distribution and sales of what they've developed. Right now it's questionable in my mind whether KERX can do it alone in North America, or whether and even bigger partnership may be established where a big Pharma either partners with them, or even with all currently involved with the company for worldwide rights. Likewise, AEZS with most its personnel in Germany may have thoughts of handling European needs themselves, or again another major regional partnership may be in the works.
As small biotechs mature, they may emerge as major Biotechs if they're not bought out themselves. If for instance Perifosine were approved prior to a partnership for AEZS-108, AEZS could consider if they'd like to consider keeping AEZS-108 completely in house, or only contracting out that portion of the effort it couldn't possibly support. The difference between partnering and contracting is a tremendous amount of money. In a partnership they'd receive a tremendous amount of money up front, and the partner would typically pick up all expenses, then on approval they'd see nice royalties on sales, not earnings, of the drug. The partner might sell $1B a year, but earn $100M, while with a 10% royalty AEZS would also earn $100M for doing absolutely nothing. If on the other hand they keep the drug in house, they'll have to pay substantial money either for a manufacturing facility, or to contract for it. Then they must pay to build a distribution and sales staff, or again, contract for it. This is all in addition to the cost of gaining approvals which grows dramatically in Phase III.
Look at DNDN, many were sure they'd go to triple digits either on sales or once they partnered Provenge. I cannot say if they turned down partnership offers because in their mind they were simply not enough, or if no such offers were made as major Pharma wasn't interested in the logistics involve in individualized drugs. Regardless, much of the shine has come off the company with weak sales.
Personally I hate seeing big Pharma swoop in and buy promising drugs for what seems like a song, but I recognize it's often the best thing a company can do. Had DNDN gotten a partner on Provenge, I don't doubt that sales would have been greater as big Pharma has the wherewithall to build sales in a manner that DNDN didn't. Single digit or low double digit royalties may seem wrong when you've done all the heavy lifting, but with big Pharma pushing a drug it might be a blockbuster many times over, while a company like DNDN is actually losing money on its sales.
While I'd love to see AEZS grow into a major Biotech capable of fully supporting full development, manufacturing, distribution and sales of their own drugs worldwide, it's a huge effort for drugs with blockbuster sales. That's not true of Solorel. It's a niche drug, major Pharma's not that interested and as of it's approval there will be no competition with other products. Because the demand for it is anticipated to be small, the manufacturing capability may already exist, at least for its launch. In short, AEZS may keep this drug completely and while it won't earn billions, it can produce tens to hundreds of millions in sales, and at least tens of millions eventually in earnings.
I wish I could say what will be the next major event for AEZS, but in reality it has many opportunities and you never know what may interest a major Pharma. If they're more excited about something that's not yet in the clinic, they could partner that before a drug such as AEZS-108 is partnered. Clearly the earlier stage a drug is in its development the less that can be demanded for it, but if Company X really wants drug Y which is preclinical, they may pay more for it than drug Z which is in Pivotal trials, but they're not interested in it. Big Pharma clearly wants Blockbuster drugs, drugs which they feel certain will sell in the billions annually. If they see a drug as promising, but with a limited market, like Solorel, the fact that it should be easily approved means little, they're not interested.
I liked AEZS because of the breadth and depth of their pipeline. Once sales are established for bigger drugs like Perifosine, if AEZS isn't bought out, it truly could become a Biotech Giant, like Amgen. At one time I could have said like Genentech as well, but it's been bought out, spun off, and bought out again by Roche and I have a feeling they may spin off a percentage of it again.
My biggest investment mistake came in roughly 1990 when AMGN was suggested to me at about $15 a share and I didn't buy. If you look at AMGN in the last decade it did essentially nothing, but if you look at it between 1990 and 2000 it rose to perhaps $80 at the end of the decade, no big deal, but it split a total of 48 to 1 during that decade, Big Deal. In short it grew so fast that by 2000 it could no longer support the growth rate, and while a giant Biotech, like Giant Pharmas new blockbuster drugs just sustain it, while blockbuster drugs can explode the price of a tiny biotech, like AEZS.
Gary
Phase IV is a post approval trial which the FDA can require, but certainly not a part of every approval.
I for one would much prefer faster approvals for Phase II or III trials which always were followed with required reporting of the outcome of all use of the drug, call it Phase IV, or something else.
AEZS's drugs are currently in, or have completed, trials which can result in Approval. The company stated that AEZS-130 will be discussed with the FDA in a pre NDA filing meeting followed by a NDA early next year. Sure, it's possible they could have rushed the NDA and filed it this year, but IMHO it's better to take your time and get it right, or at least as right as possible. The FDA asks questions all the time of drugs you know will be approved, delaying approval with each question by at least 6 months, and in some cases for years. No matter how reasonable the question is, they can ask it, and you must answer if you want a chance at approval. When a question is fully and completely answered, the FDA still has the right to ask another question which is totally unrelated to the initial question. I.E. if the FDA wishes, they can delay drug approval as long as they wish. If you look at their history, they seem to have a heavy bias toward approving the drugs from big Pharma, and delaying the drugs from tiny Biotechs, often until they're sold out of frustration to big Pharma.
When the company spoke, they did indicate at least a possibility of expedited approval for AEZS-130, previously they sounded as if they weren't even going to attempt to get it. With expedited approval the FDA has 6 months to act, without it, they have a year.
Perifosine could have it's Phase III end this year, and an NDA filed by the first half of next year. If that's the case, expedited approval is almost certain and should get a decision next year.
As I said, I'd like to see shorter approvals, but all drugs should have outcomes reported, and no outcomes could be hidden by manufacturers willing to pay someone off to withhold negative results. Problems with drugs like Vioxx or FenFen would never have reached the levels they did if negative side effects were reported from the beginning, instead of payoffs to victims or families of victims of these drugs. Has the negative effects of Vioxx been reported initially, it probably would be on the market today, but usages would be restricted to short periods, i.e. sales would have been much smaller, but they'd have been sustained.
Other AEZS drugs should go into Phase III in the not too distant future, but depending on the Phase III Trial design, approval could take several years.
Gary
Thanks Bigcue,
Now if we could learn more about what's behind the payments, we might learn that their is a business there. Of course I've believe there's a business there for some time, FH simply refuses to tell us about it.
Gary
The release gave people a half hour to review the release before the webcast, while this is common, it's normally released by most companies before or after the market day.
I'm still listening to the Webcast, but I believe it's very positive as so much seems to be happening on virtually all the drugs they've developed. By the end of the month we should see top line data on the AEZS-130 Trial which they no doubt intend to develop an NDA for this year. It is possible that they will market this niche product worldwide themselves.
I believe the company's being very open and honest about their plans, but do maintain certain information they can't discuss rightfully. It's unusual to have quarterly webcasts last an hour, this one is almost there.
Gary
Remember, this is a niche drug, it's approval will help, but it won't make you wealthy unless its application expands and/or there are theraputic uses found, not just HGH deficiency detection.
That said, the company has options on how it may handle the completion of the trial. They could announce top line data once they've received it, they could wait for a quarterly to announce it, they might present data at an appropriate technical conference, then discuss it in greater detail with investors, or they might say nothing and just proceed with NDA development and let us know when the NDA's been submitted to the FDA.
I suspect we'll either get top line data from a PR, or they discuss it at the next quarterly, probably early next month. As for NDA development, I believe we'll see it sometime later this year, but probably not until late this year.
As for the expansion of the drugs use in HGH deficience, if after use it's found that a far greater percentage of the population have this problem, use of the drug could expand dramatically. It won't happen quickly, but if a decade from now the SOC said test all patients beginning at age 50 and do so every 5 years, similar to the guidelines with colonoscopies, this could be huge.
For now, if approved late next year it will have little impact before 2013, and even then be quite small. If partnered the impact of a partnership might be greater then the drugs approval, but don't expect tens or hundreds of millions up front from such a partnership, this simply isn't that big a drug, at least not for now.
Gary
Here's a related article which shows the potential of Perifosine to go well into the billions of dollars.
http://www.cantechletter.com/2011/07/aeterna-zentaris-european-patent-perifosin/
We'll know a lot more once the top line data is revealed but once the approvals start, AEZS will either grow tremendously, or be bought out. Personally I'd rather see it grow for the next several years.
Gary
You're giving a good assessment of AEZS for Perifosine, however it's their pipeline that could really move the stock even more dramatically in the future. By the time Perifosine is approved it may be clear that AEZS-108 is close, and could be bigger than Perifosine. It's also very possible that Solarel (AEZS-130) could be on the verge of approval or approved for diagnosing HGH deficiencies, and perhaps showing benefits in other theraputic uses.
I'm not suggesting that AEZS will be bigger than DNDN on Perifosine, but when you add the others it might be the one that others site, instead of DNDN, but it will take at least a couple years.
Gary
I believe it happened roughly a week ago. No announcement has yet been made on how far the oversubscription went.
Gary
I agree, I suppose it's natural that both breast and prostate cancer have more emotional attention then others, but if you do get on the national news, or into a major newspaper or magazine, it can move the stock price years ahead, but ultimately it's earnings and anticipation of future drug approvals that will set where it can go.
Gary
I can remember when Nevada outside the cities was like the Autobahn, no speed limits. The fastest I ever drove was there, I past a few cars and was passed by a few between the California border and where Las Vegas City Limit's applied.
WRT how high, or low, the price of the stock may go, so much is determined by the emotion generated at the time. Perhaps emotion is the wrong word, but I'm speaking about what coverage the approval gets. If on one hand a P.R. is released, it's spoken about on various message boards, the Street, etc but that's as far as it goes, the lower end of the anticipated price scale would apply. On the other extreme, if say the New York Times featured the drug just approved in a feature article, don't be surprised if the stock goes even beyond everyone's wildest expectations. That's not to say this price is extreme, it's a price that would probably be justified after a few years of sales growth, it's simply achieved, and may be sustained, a few years early.
Personally I believe that Roche/IMGN's T-DM1 could be a drug that sees a lot of emotion on approval as there are a lot of breast cancer boards, chat sites, etc following the progress of this drug. I cannot say I've seen the same energy for Perifosine, that's not to say it can't happen, but I've seen no sites where those being treated with it are actively touting its virtues, I've seen that in T-DM1 for years.
Many years ago the NY Times wrote up Judah Folkman and the results he achieved in mice, ENMD, the company employing his technology rocketed from single to triple digits as I remember it briefly, but it fell back to earth and remained there. Investors have become far more sophisticated since then, perhaps to money driven to look to the future. A company that signs a partnership with $100 million up front, but single digit royalties will almost always get a greater rise then a company that signs a partnership with tens of millions up front but double digit royalties. Let's say the royalty difference is 10% and the drug reaches blockbuster levels. That's a $100 million difference in royalty level every year, and it probably grows even greater as sales continue to grow. Certainly it's great to get both, hundreds of millions up front and double digit royalties, but given a choice, I'd rather see the higher royalty level for a drug I really believed in.
Unfortunately, investors will never be told the details of negotiations, in fact, they'll only be given a ballpark feel for what's in the partnership agreement. While you have to believe nothing was set in concrete prior to the agreement, there are probably limits certain companies have which they won't exceed. I.E. if say PharmaX has never partnered with any company for more than 15% royalties, if you're in talks with them that already get you 15%, you might as well push for the higher up front and milestone payments as push for higher royalties, and perhaps get nothing. Investors never get the full picture unless it's constructed after the fact, i.e. after a drug's approved and all milestones are paid you can determine what each one was for, and in that royalty rates normally adjust upwards as milestones for increased sales occur, you really don't learn what the highest royalty rate that will be paid is until after that final milestone has been paid.
It's very possible that a stock that just reaches say $10 on approval could be worth $50 to $100 or more on a purely earnings basis after say 5 years as sales volume grows to the point where royalties reach several dollars a share. I believe Perifosine to certainly have blockbuster potential, perhaps many times over. The key may be how many cancers it's ultimately approved for. Tens of millions in royalties from the first few years may grow to hundreds of millions, or even billions, after sufficient time, though billions are doubtful. For say 100 million share issued a half billion in royalties would equal $5 a share if other operations are revenue neutral. A very conservative P/E of 10 give you $50, but certainly $150 is possible without stretching too far, and if other products are approaching approval, even more is possible. Remember, it takes time for sales and approvals to build.
Gary
Ben,
You could be very right, the question might be, how long will it rest before starting to achieve new highs, where it's next resting place might be $8 to $12 after hitting somewhere between $10 and $20. How high may the filing of a NDA for Perifosine take it, how high does it go as the FDA's date approaches, and where does it go afterwards.
While I certainly don't know the answers, I believe much may be influenced by other events.
We just recently learned that while AEZS is headquartered in Canada, the majority of its staff can be found in Germany, and others can be found in the U.S. It's a question of what their strategy is for Europe. Could they support the European market themselves? If they already have the production capability for Perifosine, a large staff headquartered in Germany, this might be a market they can handle, or the next major news could be a partnership.
We then have the filing of a NDA for AEZS-130, Solorel. While it may not have blockbuster potential, it certainly should be a revenue producer and is potentially a drug which AEZS could handle themselves, or garner a partnership. Either way it's positive news.
Finally there is news of other drugs that AEZS is developing.
My point is that while Perifosine is the near term potential major income producer, AEZS represents far more. It's how the entire company is perceived at the time that Perifosine is approved that will determine if the stock price is $10 or slightly less to $30 or slightly more.
Gary
Speaking of value, does anyone know if CTKH could build the critical components needed for a 3-D display that requires no glasses. I've not seen it myself, but was told about it over a year ago by someone attending the CES in Vegas, Samsung displayed it.
I can only assume that each eye sees a different image which is differentiated by the slightly different angle between the eye's view of the screen. I have no idea how wide the viewing angle is, or if you must be positioned fairly precisely relative to the screen. I'm also unsure just what LG is doing with glasses that don't have the electronic shuttered lenses required by others and the claim that viewing angles are far better then other sets.
I frankly believe that 3-D will be big in time, but I suspect that either Samsung's no glasses, or LG's non electronic glasses approach will dominate, depending on which can give the clearest picture with the largest viewing angles. Until virtually all the sets are built that way, I doubt if it will be high demand for those that are not.
If CTKH has something propriatary that can add to the viewing quality of 3-D TV's, no telling just how much they might earn.
Gary
You're correct if he has over 50% of all the outstanding share under his control, perhaps with some sort of preferred stock, which he may. Unless he holds them all himself, or in his family, and they dare not defy him, I question if others would still be firmly in his control after this much time at $.0001 and no financial reporting.
Clearly some stocks do report and do anything they damn please. If you're not familiar with Genta, symbol GNTA, they've been developing, testing, and failing with the very same drug, Genasense, for perhaps two decades. I certainly could be wrong, but I believe if you had 50,000 shares back in the mid 1990's which at one time were worth over $20 a share, today you'd have one single share worth less than a dime, and they'll probably do another 100 for 1 any time. I could be wrong about this, if you wish do the research and see for yourself. Over the entire time they've had the same CEO and they just keep starting new pivotal trials, and issuing more stock, between R/S's.
Gary
If he did do an R/S I believe he'd have to provide all the financials first. I don't believe even in the Pinks that the MM's, brokerages, etc. would be willing to participate without the financials being current.
I frankly am amazed that the company remains on the Pinks without filing in all this time. Another stock I followed was delisted in much less time. I have a feeling that FH does something annually to permit the stock to trade.
Gary
I agree with your assessment What's Cooking. It's very possible that CTKH is selling far more then $10 million in product, in fact it may be dramatically more, but we'll only know if FH loses control and whoever gains control does all that's necessary to become compliant. From what I've gathered, FH is brilliant in his field of expertise, it's very possible he's making products which are truly very superior to his competition. Unfortunately, FH has also become a total maverick when it comes to doing what's expected from a company which complies with security regulations.
All's not lost. I'd practically given up on APPI, they hadn't reported for years, suddenly the symbol was changed to WHEN and years of back filings were submitted. The company changed directions, but it now trades, has a business plan, and there is hope. It's still under $.01, but it's roughly 40 times what CTKH is and many believe $.01 or better's in the not to distant future.
I know FH once did a reverse split and swore to never do another. While I don't like R/S's, I also don't like billions of shares outstanding at prices below a penny. I do believe that CTKH is in an industry that could warrant a multi billion dollar market cap, but it cannot happen without being fully reporting, and having earnings that go into the hundreds of millions. Again, nothing is impossible, there are plenty of companies with billions of shares outstanding, the key is they have credibility, CTKH does not.
Gary
Thanks Denver,
I do frankly believe that diesel produced from algae will be very similar to biodiesel, my caution is that some older diesels have catastrophic results using biodiesel. Also if further refinement results in a gasoline replacement, other problems can result there as well.
Personally I believe we need to cut our generation of combustion products tremendously, with one exception, water. If we use hydrogen for fuel, it's combustion results in water vapor and while even there it may change climatic conditions, with reductions in other pollutants I believe we can deal with that.
What's interesting is that an internal combustion engine can run on hydrogen, but so can a fuel cell, and I believe the fuel cell can be far more efficient, however as cleanly as hydrogen burns, it's possible that thermal efficiency could be dramatically improved in piston engines that didn't require all sorts of devices to reduce pollution.
If we had cheap, plentiful electric power produced by fusion, wind, solar, etc it's easy to get hydrogen for use in cars, trucks, planes, trains, etc if we wish.
Gary
It certainly appears that Cetek is involved in all sorts of things which potentially are making money, perhaps even lots of money. The question is, "Should this rightfully be our money?".
Has FH set up Cetek not to be part of CTKH?
I have no idea how he can get away with what he does, nor do I know if his annual earnings are 5, 6, 7, 8, 9, or 10 figure, or larger. Frankly, Cetek is in an industry where billions in earnings are possible, that would bring our stock price into the $10's, on the other hand if he's earning under $100K, our shares may be very fairly priced where they are. The point is, we don't know.
All we know is the Cetek keeps popping up in places where advances in technology are being discussed.
Personally I won't put another cent into CTKH but if someone could find an attorney willing to say 10% of my shares if he could gain CTKH becoming a company that's fully disclosing what they're doing and meeting SEC regulations, I'd certainly pledge my shares and believe others would do the same. With over 1 million shares 10% might only represent a couple dollars, but what if we find this stock actually deserves over a penny in valuation, how about a dime, it starts to add up to real money. I believe there are many like me, if there's an attorney out there who could shake this lose, they could put hundreds of millions of shares in their account, that's a good size payoff if we should be worth $.01.
Gary
Does anyone know the specifics about the fuel they're creating. I'm sure that most diesels will run on it, however, in at least a few diesels I'm aware of that were in marine applications the bio-diesel they used led to major engine rebuilds as the gasket material used was broken down by the fuel. In some cases bio-diesel or gas that had enough alcohol added was know no break down the plastic fuel tanks and/or hoses found in certain boats.
I bring this up not to discourage investors, rather I'd like to know first if this isn't a problem with fuel derived from algae, which I'm uncertain of, but even if it's the case, I believe it's just a matter of time until either everything necessary will have to be retrofitted, or boats, cars, trucks etc that cannot handle bio-diesel or gasohol fuels will be limited as to where they can purchase fuel.
While I'm reasonably certain anything manufactured in the last several years should be okay, there are many boats in service for 50 years and more which never envisioned fuels of this sort, as I understand it, the same is true of aircraft which cannot handle totally unleaded fuels, and probably not bio fuels either.
I'm a big believer that almost all our garbage and even sewage can be turned into something useful, and I don't doubt that in some case algae can be used to break it down. While personally I'd really like to see a push into fusion for electricity, then safe hydrogen technologies for most portable power applications ranging from cars to computers which fuel cells can power for much longer than conventional batteries. Right now this is pie in the sky, but if cheap electric power is ever created with fusion, then hydrogen powered fuel cells won't be far behind in sizes that will power everything from mobile phones to 18 wheelers.
We'll probably always need some petroleum or bio based liquid fuels for certain things like aircraft, but the majority of what's being brought out of the ground today could be dramatically lower.
Gary
No stock move up every day, a small retrenchment is very normal. Some would say even more is needed, I'm no technical expert, but I believe technicians can always make it sound like a stock is following the path T/A says it will.
It's all about controlling the numbers. After the fact a technician could look at the recent increase and say it began at $2, reached a peak of $2.68 which it just hit and in closing at $2.36, the 32 cent retrenchment represents nearly a 50% retrenchment. Someone else would say the base should have been $1.80, would only consider the closing high of $2.54 and the 18 cents it was down at the close, so the retrenchment was less then 25% of the gain.
If the stock rises from here, the first T/A expert would be deemed correct, if the stock fall slightly further before continuing the advance, the second would claim to be right. Regardless, there will also always be a third, fourth, etc who'll claim a totally different set of parameters. The stock floor was really begun at $1, or the high should be based on the highest weekly close, rather than the highest intra-day price, thus we're currently at the high and haven't retraced at all.
I'm not putting down T/A, just suggesting that like Economics, it's not a precise science. They say if you put 20 Economists together you get at lease 21 opinions. I believe much the same can be said about those practicing T/A.
I believe AEZS is still dramatically under-priced and will remain so until its market cap is equal or greater then that of KERX. I also believe that KERX should be a good investment, just not as good as AEZS, i.e. I expect that when AEZS's market cap equals KERX's, the market cap of KERX will be up substantially from where it is today.
As always, JMHO.
Gary
http://www.azom.com/suppliers.aspx?SupplierID=5580
This is what I found when I added Cetek to your search, were there others where Cetek was specifically mentioned on developing flat screens.
Thanks,
Gary
The company never said more then what Homeland Security said about when then intended to purchase FMD Vaccine. I cannot say if delays have been caused by wanting further improvements to the vaccine, or it it's a contracting or funding matter.
I've unfortunately had to tolerate the actions of govt. buyers who feel they're acting in the best interest of the Govt. I've seen millions spent because the or equal that buyers insisted on were equal in performance, but not geometry thus all sorts of fabrications had to be scrapped, designs redone, but they got the equipment for a few dollars less then what was requested.
I also was involved in a project where six P.C.'s were needed, the total cost was about $3000. The buyer ground down the company selling the computers, it took nearly 3 months of grinding, but they saved the govt. about $500 in the total transaction. It didn't matter to the buyer that the delay forced me to put my people on maximum overtime to get the work done that they were initially purchased for. Over time having the computers made tremendous savings over typing all sorts of documents, but tens of thousands were spent in overtime because the buyer believe it was her duty to save the govt. that $500 with no consideration of the time she was taking to do so.
I have no idea if the purchase of FMD is awaiting funding, or if they're still tweaking the vaccine, or if they've decided to buy the commercialized version that GNVC's developing with Merial rather then what they have now. My point is GNVC didn't lie, they occasionally reported what could be found in H.S. based documents, but H.S. didn't do what was shown in those documents. Is it really a surprise that anything the govt. schedules takes longer than they estimated.
Someone once said it would take Congress a week to decide how to make 4 minute eggs. On reconsideration they determined it couldn't possibly be done in under a month. They went on to specify all that would have to happen to make such a determination and it was far more likely that 6 months would be needed.
Is anyone really surprised that the purchase of FMD Vaccine has been delayed?
Gary
I agree. Even if I could sell at .0001 or even .0002 it's hardly worthwhile. I can only hope that at some point FH, his family, or others he's sold the majority of the shares to want the company to truly be public again.
It hasn't done much, but I believe I've previously mentioned WHEN which used to be called APPI. After years of not reporting or complying with any regulations they suddenly filed years of financials all over about a 2 day period. Hopefully they also plan to build the company which now is based on growing biofuels.
I do believe that CTKH does have profitable products and technologies, perhaps some day they'll realize the shareholders could be wealthy if sales and profits were divulged. While I frankly question trading for over a dollar without a reverse split, trading in pennies would make many of us good money.
Gary
You're correct, I know he did it, and swore he'd never do it again, but I wasn't around when it was done.
I'm not suggesting he's great, but by comparison to a CEO that turned $1 billion worth of stock to a dime, he's done better.
I originally purchased CTKH for under a penny, the only such purchase I've ever made. I don't know if FH will ever go public again and try to rejuvenate the stock, but at this point what I own isn't worth enough to bother selling.
Gary
If you want to see what artfully done reverse splits can do, take a look at Genta. 50 million shares, worth about $1 billion in 1996 today have been reduced to one share worth about a dime. The CEO remains the same person who served in that capacity then.
I certainly don't like what FH has done, but compared to the CEO of Genta, he's done great.
Gary
While I agree with you long term, even if they do the 1 for 10 reverse split, but if they do that split, I believe post split shares will be available even cheaper then ten times the current price.
I believe if they announced a reduction in the rate to 2 to 1 and were confident that $1 would be achieved, that confidence would be seen in the stock price, the R/S supported, and the price would immediately rise above 50 cents before the R/S. If they keep the information flow going on what they're doing, sustaining $1 after an R/S could be easy.
On the other hand if all R/S's are voted down, I believe the share price will move up nicely. As currently structured unvoted shares count as votes against the R/S as to pass they must get 50% +1 vote of all outstanding shares, not simply a majority of the shares voted with over 50% of the O/S voting. This is a higher standard then most companies set, but if achieved it improves the chances of success.
Once GNVC's technology advances further and shows additional successes I believe people will see what a bargain today's prices are, but the current trials are not structured to rapidly gain results, they're rather like watching grass grow.
Gary
GNVC has stated that they expect no royalties from Merial in 2011, but it's also clear that the Merial partnership is not a part of the material which Homeland Security may purchase for the U.S. It's unclear that Merial would provide the vaccine, but if they do so it would not be under the partnership terms.
It has also been indicated that the final composition of the commercial drug could be different from what H.S. wanted. If that were the case, I believe U.S.D.A. or whatever approval is sought would be different from the approval currently in process for the vaccines developed for H.S.
On the subject of the Reverse Split, anyone who's followed the dialog I had with Doug on Facebook before he took it down knows that I and others don't support the 1 for 10 proposed by the company. I can see no reason why Outstanding Shares should be reduced to under 13 million. I believe somewhere between 65 and 40 million shares would be justified, i.e. a 1 for 2 or perhaps as much as 3. Any higher then that I'll oppose, and I hope others do.
Gary