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Vsualyz, OT - Yes, I should be more positive. I think my negativity stems from not wanting to be disappointed, so I set the expectation bar on the low side. Speaking of synchronicity -
>>> Synchronicity is a word that Swiss psychologist Carl Jung used to describe the "temporally coincident occurrences of acausal events." Jung spoke of synchronicity as an "'acausal connecting principle'" (i.e. a pattern of connection that cannot be explained by direct causality) a "‘meaningful coincidence’" or as an "‘acausal parallelism’". Cause-and-effect, in Jung's mind, seemed to have nothing to do with it. Jung introduced the concept in his 1952 paper "Synchronicity — An Acausal Connecting Principle", though he had been considering the concept for almost thirty years.[1]
Put plainly, synchronicity is the experience of two or more occurrences (beyond coincidentally) in a manner that is logically meaningful- but inexplicable- to the person or persons experiencing them. Such events would also have to suggest an underlying pattern in order to satisfy the definition of synchronicity as developed by Jung.
It differs from mere coincidence in that synchronicity implies not just a happenstance, but an underlying pattern or dynamic that is being expressed through meaningful relationships or events.
It was a principle that Jung felt encompassed his concepts of archetypes and the collective unconscious [2], in that it was descriptive of a governing dynamic that underlay the whole of human experience and history — social, emotional, psychological, and spiritual.
Jung believed that many experiences perceived as coincidence were due not merely to chance, but instead, suggested the manifestation of parallel events or circumstances reflecting this governing dynamic. [3]
One of Jung's favourite quotes on Synchronicity was from Through the Looking-Glass by Lewis Carroll, in which the White Queen says to Alice: "It's a poor sort of memory that only works backwards". [4]
A well-known example of synchronicity is the true story of the French writer Émile Deschamps who in 1805 was treated to some plum pudding by the stranger Monsieur de Fortgibu. Ten years later, he encountered plum pudding on the menu of a Paris restaurant, and wanted to order some, but the waiter told him the last dish had already been served to another customer, who turned out to be de Fortgibu. Many years later in 1832 Émile Deschamps was at a diner, and was once again offered plum pudding. He recalled the earlier incident and told his friends that only de Fortgibu was missing to make the setting complete — and in the same instant the now senile de Fortgibu entered the room.
During production of the The Wizard of Oz, a coat purchased from a second-hand store for the costume of Professor Marvel was later discovered to have belonged to L. Frank Baum, author of the original children's book upon which the film is based. [5] <<<
Money4, No plans to visit California in the near future :o) That would undoubtedly trigger the big earthquake they've been expecting, so I'll spare them the devastation :o)
The day I arrived in Italy/Sicily (2003), the entire country's power grid collapsed. Another year I went to Paris, and a week later the entire country erupted in riots. Then last year I decided on London, just in time for the terrorist plot to blow up airliners with liquid explosives. I won't even mention the hurricane Katrina connection. Coincidence, or the Twilight Zone? You decide :o)
Daviddal, OT - I looked at DSCO a year ago when they were waiting for an FDA decision to resolve an approvable letter on Surfaxin. There were manufacturing related issues, but they failed to get them resolved, so they're still spinning their wheels. I thought Surfaxin itself sounded like a promising product, but I think the latest problem is that the formulation isn't stable and deteriorates during storage. Here's a recent article (see below). I haven't really followed them for some time, but it looks like it'll be another year at the earliest for a possible resolution. Their relationship with the FDA has been lousy.
The company is based near where I live, so I cruised by there a year or so ago to snoop around. Shortly thereafter the FDA shot down their attempt to resolve the approvable letter, so my fact finding visit once more represented the "curse of death" for a company (the previous time I did that the company of interest went bankrupt several months later :o) -
>>> Discovery Prepares for Its Fate
http://www.fool.com/investing/high-growth/2007/02/28/discovery-prepares-for-its-fate.aspx
Brian Lawler
February 28, 2007
Pharmaceutical investing can sometimes be the worst kind of torture. You have to wait months and months for a regulatory decision or clinical trial results, and if the outcome isn't positive, then you usually have to wait some more. Investors in Discovery Laboratories (Nasdaq: DSCO) must be developing nerves of steel, because they've had two years of waiting since the company first received an approvable letter for its respiratory treatment, Surfaxin.
Today, Discovery released its fourth-quarter financial results. With no revenue-producing products to speak of yet, the only financial metric that's interesting is its cash level. At the end of the year, it had cash and investments of $27 million, and an 8-million-share financing facility it could draw down on at its leisure.
The failure to get approval for Surfaxin back in 2005 has been disastrous to Discovery's financial health. It has diluted investors to the tune of a 40% growth in shares outstanding relative to the start of 2005, and more dilution is surely on the way for 2007. To be fair, Discovery would have needed to do some sort of financing anyway to help commercialize the drug, but not to this extent.
Discovery is sticking with its guidance for filing its approvable letter response in September or October of this year, with a six-month review period by the FDA. It's currently running batches of Surfaxin through stability testing to bolster the approvable letter response.
Until those regulatory wheels start spinning again in six months, investors in shares of Discovery will be playing the pharmaceutical-stock waiting game. This is always the toughest game to play, so it will be interesting to see whether shares of Discovery get even cheaper before it hears back from the FDA next year. <<<
MarketFest, OT - Speaking of Intel, I'm currently reading one of Andy Grove's books, which deals with his childhood and early years. His famous saying at Intel that "only the paranoid survive" I always thought was appropriate for the bio sector as well.
Concerning trading, I remember back in the 1990's looking for an ideal stock to trade, and came upon Intel's chart, which at that time had an amazingly regular pattern. It was uncanny, a perfect wave-like pattern repeating itself in a steady, predictable way. On the 2 year chart were 8 or so identical, perfectly spaced price swings. I figured what a great opportunity, and got ready to start trading it using the technical indicators like MACD/stochastics, etc. I figured I'd do one "virtual" trade first without real money just to make sure, and you know that stock suddenly went haywire, ending its long string of predictable moves. Unbelievable, I must have jinxed it or something. Anyway, I've seen similar things happen numerous times since then, and have begun to think that stocks sense me coming and somehow conspire to thwart even my best laid trading plans. If it was merely chance then I should have had a 50% success rate with trades over the years, right? Go figure..
Anyway, the one thing I seem to be able to do reasonably well is to identify good stocks. Timing of purchases/sales is another story. So if I can somehow get a decent sized stake from this Cortex trade, I'll put the money into a diversified group of solid stocks (my "virtual" portfolio is now up to 75 stocks believe it or not, though only half are bio related, and half of those are in the bio picks/shovel category). With a large portfolio of solid long term type stocks like that, there's little need to trade, so the buy/sell timing isn't much of a factor.
Wahjjhugo, Once the dosing is liberalized, Cortex can do either (outlicense or in-house). I've been assuming that CX-717 would be outlicensed for ADHD not long after the FDA liberalizes the dosing, and then the BP would take it from there. But getting the Phase 2b IND approved also gives Cortex the ability to continue developing CX-717 in-house if they choose, and then do a larger outlicensing deal later. Both routes would have their advantages.
If the outlicensing happens sooner rather than later, I'm not sure if the BP partner would have to get a new/separate IND of their own for their Phase 2b, or perhaps the IND that Cortex gets would be sufficient. Perhaps Neuro has the answer to that one.
I'd settle for some of those 5 year warrants :o) Actually, because of my uncanny ability to get in at the top and out at the bottom, I've decided to dollar cost average this time around. While this won't guarantee a profit, at least the losses should be less :o)
See, I told you guys I could tank the stock at will. As the best contrarian indicator on Wall St, I should be highly compensated :o)
Bio-Generics (3-07) - Will Biological Drugs Go Generic?
>>> A bill in Congress could let generic drugmakers manufacture these pricey meds. But biotechs like Amgen claim they're too complex for others to make safely
by John Carey
In the fight to tame health-care costs, generic drugs provide a rare success story. These copies of brand-name medicines now account for 60% of all U.S. prescriptions. They shaved tens of billions of dollars off the nation's $213 billion drug bill in 2006.
But this remedy has a serious limitation: Generics are allowed only for traditional, chemical compounds whose patents have expired. You can't get them for complex biological drugs such as hormones or antibodies used in cancer treatments. Some of the world's most potent and popular medicines fall into this biotech basket, and existing federal laws prevent them from going generic.
While that's good news for biotech companies, whose drugs enjoy staggering monopoly prices, it's agony for patients and their insurers. A year's worth of Genzyme's (DNA) Cerezyme, for a rare ailment called Gaucher's disease, can top $200,000. Genentech's cancer drug Avastin costs as much as $100,000 per year. That places a huge burden on companies who cover the treatments in their health plans, and on consumers with high co-pays. "It's our single fastest-growing category of health costs," observes Sidney Banwart, human-services vice-president at equipment maker Caterpillar (CAT). "The trend is simply not sustainable."
Safety Concerns
To patients, insurers, generic drugmakers, and companies like Caterpillar, the obvious answer is to open the floodgates to generic biologics. These groups have put their weight behind a bill introduced in the Senate by Hillary Clinton (D-N.Y.) and Charles Schumer (D-N.Y.) and in the House by Henry Waxman (D-Calif.). It asks the Food & Drug Administration to establish a new process for reviewing and approving such treatments.
Even some traditional biotech and pharmaceutical companies have signed on, attracted by the fact that key patents on first-generation versions of the world's most successful biotech product have already expired. That drug is erythropoietin (Epo), an $11 billion per year worldwide anemia treatment sold by Amgen (AMGN) and Johnson & Johnson (JNJ). "Billions of dollars are at stake," says Dr. James Bianco, chief executive officer of drugmaker Cell Therapeutics, which would like to get into the generic-biologic business.
What's holding the floodgates shut, for the moment, is a set of concerns about patient safety. Companies such as Amgen and Genentech would be hit hardest by the bill, and they make a plausible case that biological medicines are too complex to mimic. Competitors would be "unable to make copies that are the same," says Walter Moore, Genentech's vice-president of government affairs. Even a relatively simple biologic drug like blood-thinner Lovenox, extracted from pigs, contains over 100 individual molecules.
Same Old Story?
One false step in manufacturing, and patients can get very sick, as Johnson & Johnson learned producing Epo under a license from Amgen. It made a small change to its manufacturing process, which involves growing the medicine in cells from the ovaries of Chinese hamsters, and introduced a stabilizer ingredient that was thought to be safe. But the stabilizer interacted with the rubber stopper on each vial, creating substances that caused the body's immune system to attack the production of blood cells. Scores of patients were hit with this severe side-effect.
Opponents of the new drug bills argue similar lapses are certain to occur if there's a wave of generic biotech products, and that a lot more people are likely to suffer.
Many experts believe such fears are overblown. Before the first generics law was passed in 1984, "We heard the same kind of stories of woe and terror," says George Barrett, CEO of Teva North America (TEVA), a maker of generic and brand-name drugs. He and many others believe it's inevitable that Congress will pass a bio-generics bill—not least because of cost concerns.
America's tab for biological drugs was about $30 billion last year. But with more than 400 new biotech medicines in clinical trials, the cost is expected to jump to $90 billion by 2009 and keep climbing. "This is throwing nitroglycerin on the fire of health-care costs," says Consumers Union analyst William Vaughan. "We've got to get an answer to this."
An Air Bag for Biotech
Any new law, however, will take generic biologics only so far. First, it would take several years after the bill is passed for the FDA to issue regulations. Then, because of safety concerns, the agency is expected to require some clinical trials before approving generic competitors, slowing their entry to the market. And it's unlikely that the copies will automatically be substituted for brand-name drugs, the way today's generics are. Instead, they will be seen just as another choice.
Such developments will be "like an air bag to protect the biotech industry," says Ira Loss, senior health analyst at Washington Analysis, an investment-research firm. "They may get a broken arm, but it won't have to be amputated." This gradual solution will also mean that generic biologics won't have a huge, immediate impact on health-care costs. An analysis by Avalere Health pegs the estimated savings for the federal government at $3.6 billion in the first 10 years after a bill passes, with equal or greater savings in the private sector. Further out, though, the savings would rise substantially.
However that shakes out, the measure can't come too soon for Kathy Ramert, 54, a single mom in Tucson, Ariz., with multiple sclerosis. Even with health insurance, the accountant pays $822 a month for her medicine. "This is what's keeping me going," she says. "Any savings would be a huge help." <<<
Thanks for the info. Actually I'm with Ameritrade, but their procedure is probably similar.
Well, looks like it's waiting time now. I guess there may not be additional press releases for the filing of the tox data or the filing of the ADHD Phase 2b IND, or if there are they will probably be brief. That's just as well since it's probably wise now for Cortex to stay quiet and let the FDA do their thing.
The only other potential wildcard I can think of prior to the FDA decision (other than overall market volatility) would be an announcement of the non-Ampakine inlicense, though that might happen afterward. I doubt we'll hear much from Schering over the next few months, though that could get interesting later in the year.
My plans are to gradually add over the next 4 weeks or so, and then just hang with it until the FDA announcement. I'm figuring the odds are approx 85% favorable, which seems like a risk worth taking. Alternatively, if the stock should get over $3 prior to the decision and my cost basis is $2.20-2.40, then I might take out some profits pre-decision and let the balance ride. Fingers and toes will be crossed for this one, but it looks like the odds are clearly in our favor :o)
Genzyme (3-07) - Cashing in on 'orphans'
Pharmaceutical companies like Genzyme reap huge profits off treatments for obscure diseases.
>>> By Aaron Smith, CNNMoney.com staff writer
March 15 2007: 9:48 AM EDT
NEW YORK (CNNMoney.com) -- Some of the most successful blockbuster drugs in the world treat diseases that most people have never heard of.
They're called orphan drugs, and the government doles out big tax breaks to companies that deliver them. Even without the tax incentives, plenty of biotechs have found ways to profit big off drugs for rare diseases.
How do they do it? By charging gobs of money.
Consider Genzyme (Charts), one of the more prolific producers of orphan drugs, also known as "orphans." The Cambridge, Mass.-based biotech has three on the market, including a $1 billion-a-year treatment for a debilitating, hereditary disease called Gaucher.
Cerezyme, Genzyme's Gaucher drug, is one of the world's most expensive drugs. An annual supply can cost $200,000. Of the estimated 100,000 Gaucher patients worldwide, 5,000 take Cerezyme, according to company spokesman Dan Quinn.
"Genzyme charges a higher price per patient because patients need the drug and there's no other enzyme replacement therapy out there [that's] approved," said Biren Amin, analyst for Stanford Financial Group.
Genzyme isn't the only company to strike it rich off orphans.
Novartis and Amgen have also excelled at this business. Novartis (up $0.00 to $56.50, Charts) sells Gleevec, a treatment for chronic myeloid leukemia that (along with the drug Glivec) totaled $2.5 billion in 2006 sales. Amgen (down $0.10 to $60.59, Charts) has Epogen, which started out as an orphan but is now used to treat anemia. With $2.5 billion in sales last year, Epogen is now one of the world's top-selling drugs.
At first glance, a blockbuster drug that treats a rare disease seems to defy logic. Some of the best-selling medications, after all, have been treatments for the most common diseases where demand and public awareness are highest.
For instance, the top-selling drug of all time is Lipitor, a cholesterol-lowering statin from Pfizer (up $0.00 to $24.86, Charts) with nearly $13 billion in 2006 sales. Merck's (up $0.00 to $43.27, Charts) fast-growing Zetia/Vytorin cholesterol franchise, meanwhile, had nearly $4 billion in 2006 sales, a 60 percent leap from the year before.
Why, then, invest years and untold millions in betting on treatments that, if successful, relatively few patients will ever need? It isn't just because the IRS allows orphan drugmakers to write off up to 50 percent of the cost of clinical trials. It's also because approved treatments command premium prices which quickly add up even if only a small portion of an orphan disease's victims buy them.
In addition to Cerezyme, Genzyme sells two more orphan treatments. One is Fabrazyme, a medication for a disease similar to Gaucher that's known as Fabry. The other is Myozyme, a drug for Pompe disease, a debilitating and often fatal neuromuscular disorder. Like with Cerezyme, costs for these medications can run to $200,000 a year.
But the high cost of orphan drugs have angered pharmaceutical industry critics, who accuse companies like Genzyme of profiteering.
Shiv Kapoor, analyst for Montgomery & Co., said any criticisms of Genzyme are misplaced. But for Genzyme and its three orphan drugs, patients suffering from Gaucher, Fabry, and Pompe would have "nowhere to go," he said.
What's more, Kapoor estimates that Genzyme spent nearly $4 billion on research and development over the last nine years on orphan drugs. The company's 30 percent profit margin, he added, is "similar to other biotechs."
Genzyme hasn't raised the price of Cerezyme since it was approved more than a decade ago, said Kapoor. "If Genzyme was unscrupulous and really wanted to milk these drugs, they would be taking a 15 to 20 percent price increase."
Genzyme spokesman Dan Quinn says that anyone who needs Cerezyme gets the drug, even if he or she is uninsured.
"We work to try to find [insurance] coverage for patients," said Quinn. "But for patients who are not able to get insurance coverage, we do provide treatment free of charge."
Quinn said that policy applies to all three of the orphan drugs.
Aaron Reames, analyst for A.G. Edwards, said that Genzyme's practice of providing the drug for everyone in need is one reason why its orphans costso much.
Only competition from generic drug makers is likely to drive down the price of orphan drugs, analysts say. But in the case of Cerezyme, that won't happen until the drug's patent expires in 2013. And since there isn't a FDA regulatory system in place for generic version of biogenerics, it might take longer than that for a viable rival to come to market.
The lack of competition is one reason why medications like Cerezyme are called orphan drugs in the first place. It also means that orphans will continue to be cash cows for their developers, at least in the short term.
"There will be competitors [to orphan drugs], but most of the competition will probably come from biological generics," said Kapoor of Montgomery. "That's a ways off so I don't expect anything to change in the near term."
<<<
Cortex (3-07) - Reports Fourth Quarter and Year End Operating Results
Thursday March 15, 8:30 am ET
>>> IRVINE, Calif.--(BUSINESS WIRE)--Cortex Pharmaceuticals, Inc. (AMEX: COR - News) reported a net loss of $3,462,000, or $0.10 per share for the quarter ended December 31, 2006 compared with a net loss of $3,739,000, or $0.11 per share for the corresponding prior year period. For the fiscal year ended December 31, 2006, Cortex reported a net loss of $16,055,000, or $0.47 per share compared to a net loss of $11,606,000, or $0.36 per share for the corresponding prior year period.
Results for the quarterly periods reflect the timing of clinical expenses, including amounts recorded for Cortex's Phase IIa clinical study in Attention Deficit Hyperactivity Disorder ("ADHD") during the quarter ended December 31, 2005. For the annual periods, increased operating expenses in 2006 include non-cash stock compensation charges and amounts related to addressing the earlier clinical hold on Cortex's AMPAKINE® CX717 by the U.S. Food and Drug Administration ("FDA").
As required, Cortex adopted Statement of Financial Accounting Standards 123® -- "Share-Based Payment" ("SFAS 123R"), as of January 1, 2006. Under SFAS 123®, expenses for grants of employee stock options are recorded in the financial statements based on their estimated fair values. Compared to the prior year, Cortex's total non-cash stock compensation charges increased by $3,063,000 for the year ended December 31, 2006. These stock compensation charges have no impact on Cortex's available cash or working capital.
Increased operating expenses during 2006 also reflect amounts for toxicology studies requested by the FDA related to the earlier clinical hold on CX717. These additional unplanned costs represent more than $3 million of Cortex's total research and development expenses.
As reported earlier, the FDA released the clinical hold on CX717 in early October 2006, subject to specified dose limitations. Those limitations meant that Cortex could not proceed with further clinical development of CX717 as a treatment for ADHD. Cortex initiated three-month toxicology trials in rats and monkeys in order to obtain additional data. In February 2007, Cortex announced that the histopathological changes previously reported for CX717 occurred postmortem in the animal tissue. When similar tissue was rapidly removed from the animals and placed in an appropriate buffered medium, the tissue showed no signs of any histophathological changes and was physiologically normal. However, the same tissue subsequently exposed to the fixative solution rapidly began showing histopathological changes.
Cortex plans to submit the related results from these studies to the FDA in mid-March 2007 in order to request that the current dose range limitations on CX717 be raised to allow Cortex to initiate further clinical studies in ADHD. In early March 2007, Cortex submitted a letter to the FDA requesting a meeting to discuss the filing of an IND to conduct a Phase IIb study using CX717 and notified the agency that the data supporting this discussion will be filed by the end of March. The decision regarding the adequacy of the data to allow Cortex to proceed will be made by the FDA.
Decreased revenues during the 2006 periods reflect the winding down of the research collaboration with the Company's partner, Servier. As earlier announced, Cortex notified Servier of its intent to end the research collaboration effective early December 2006.
Cortex's cash and marketable securities amounted to $9,449,000 at December 31, 2006. In January 2007, Cortex announced that it had received gross proceeds of approximately $5,600,000 from a registered direct offering of its common stock and warrants.
As reported earlier this month, Cortex has added Dr. Leslie Street as its Head of Medicinal Chemistry. Dr. Street was hired to replace Dr. Gary Rogers, the Senior Vice President of Pharmaceutical Research, who announced that he will retire at the end of March 2007, after which time he will serve as a consultant to the Company. In connection with his employment, Dr. Street was granted options to purchase an aggregate of 100,000 shares of Cortex common stock with an exercise price equal to the closing sale price of the common stock as reported on the AMEX on March 5, 2007.
Cortex Pharmaceuticals, Inc.
Cortex, located in Irvine, California, is a neuroscience company focused on novel drug therapies for neurological and psychiatric disorders. The Company is pioneering a class of proprietary pharmaceuticals called AMPAKINE compounds, which act to increase the strength of signals at connections between brain cells. The loss of these connections is thought to be responsible for memory and behavior problems in Alzheimer's disease. Many psychiatric diseases, including schizophrenia, occur as a result of imbalances in the brain's neurotransmitter system. These imbalances may be improved by using the AMPAKINE technology. Cortex has alliances with N.V. Organon for the treatment of schizophrenia and depression and with Les Laboratoires Servier for the development of AMPAKINE compounds to treat the neurodegenerative effects associated with aging and disease. In December, 2006 Cortex terminated the research collaboration with Servier enabling Cortex to pursue the use of AMPAKINE compounds in the treatment of neurodegenerative diseases. However, Servier retained the right to select up to three compounds from the collaboration for its further development for the treatment of neurodegenerative diseases. Cortex may receive additional milestones and royalties if either Organon or Servier is successful in developing and commercializing AMPAKINE compounds.
Forward-Looking Statement
Note -- This press release contains forward-looking statements concerning the Company's research and development activities. The success of such activities depends on a number of factors, including the risks that the Company's proposed products may at any time be found to be unsafe or ineffective for any or all of their proposed indications; that competitors may challenge or design around the Company's patents or develop competing technologies; and that preclinical or clinical studies may at any point be suspended or take substantially longer than anticipated to complete. As discussed in the Company's Securities and Exchange Commission filings, the Company's proposed products will require additional research, lengthy and costly preclinical and clinical testing and regulatory approval. AMPAKINE compounds are investigational drugs and have not been approved for the treatment of any disease.
Cortex Pharmaceuticals, Inc.
Condensed Statements of Operations
(in thousands, except per share data)
Three months ended Fiscal year ended
December 31, December 31,
----------------------- ---------------------
2006 2005 2006 2005
----------- ----------- ---------- ----------
(Unaudited) (Unaudited)
Revenues $ 313 $ 606 $ 1,177 $ 2,577
Operating expenses (A):
Research and
development 2,899 3,409 13,262 11,361
General and
administrative 1,012 1,097 4,616 3,376
----------- ----------- ---------- ----------
Total operating
expenses 3,911 4,506 17,878 14,737
----------- ----------- ---------- ----------
Loss from operations (3,598) (3,900) (16,701) (12,160)
Interest income, net 136 161 646 637
Change in fair value of
common stock warrants -- -- -- (83)
----------- ----------- ---------- ----------
Net loss $ (3,462) $ (3,739) $ (16,055) $ (11,606)
=========== =========== ========== ==========
Loss per share:
Basic and diluted $ (0.10) $ (0.11) $ (0.47) $ (0.36)
Shares used in computing
per share amounts
Basic and diluted 34,915 32,702 34,349 32,665
(A) Operating expenses
include the following
non-cash stock
compensation charges:
Research and
development $ 424 $ 49 $ 1,997 $ 183
General and
administrative 201 -- 1,234 (15)
----------- ----------- ---------- ----------
$ 625 $ 49 $ 3,231 $ 168
=========== =========== ========== ==========
Cortex Pharmaceuticals, Inc.
Condensed Balance Sheets
(in thousands)
December 31, December 31,
2006 2005
------------ ------------
Assets:
Cash and cash equivalents $ 1,650 $ 2,063
Marketable securities 7,799 15,198
Other current assets 525 256
------------ ------------
9,974 17,517
Furniture, equipment and leasehold
improvements, net 428 439
Other 33 33
------------ ------------
Total assets $10,435 $17,989
============ ============
Liabilities and Stockholders' Equity:
Accounts payable and accrued expenses $ 2,056 $ 2,681
Unearned revenue -- current -- 126
Deferred rent liability 58 50
Stockholders' equity 8,321 15,132
------------ ------------
Total liabilities and stockholders'
equity $10,435 $ 17,989
============ ============
MORE INFORMATION AT WWW.CORTEXPHARM.COM<<<
Tonyvanw, board, You mentioned buying before the market opened. Never having done any buying/selling in the pre/post-market myself, does anyone know how this is done? Does one's brokerage account have to be set up in a particular way for this type of activity? Thanks.
Aiming, The most recent activity wouldn't have been related to the excercising of PIPE related warrants, since the outstanding warrants were all priced higher, at $2.55, $3.00, and $3.25. The recent PIPE had warrants priced at $1.66, but they can't be excercised until 6 months after the recent financing date in January, even though they're already in the money.
I'll have to go back to the most recent Cortex filing to get the exact current amounts of unexcercised/outstanding warrants, but here's a summary of the remaining warrants from the first 3 PIPES as of a year ago (3-31-06). I doubt it's changed much since then since the share price was only as high as the low/mid $3 range between April '06 and now. Some of the $2.55 warrants may have possibly been excercised however last Spring/Summer -
PIPE #1 (8-03) - 1,883,335 warrants remaining as of 3-31-06, excercise price of $2.55 (potential proceeds of $4.8 mil).
PIPE #2 (1-04) - 3,969,137 warrants remaining as of 3-31-06, excercise price of $3.25 (potential proceeds of $12.9 mil).
PIPE #3 (12-04) - 1,775,689 warrants remaining as of 3-31-06, excercise price of $3.00 (potential proceeds of $5.3 mil).
Moose, Yes, that would have been the smart way to play it. Clearly, the easy/safe money has been made in the past several weeks. If my funds had been in place I would have bought in that 1-2 hour window the day after Stoll's presentation. But having missed that and the subsequent runup, the question is how to play it now.
The assumption that there will be a similar lag time after the FDA related press release is where I have some serious doubts. I figure if the pre-announcement price is say $3.00-$3.50, then the stock will probably open around $5.00 or so. So the only sure way to participate in that upside is to be onboard through the decision period. That is by far the riskiest period however, so therein lies the rub.
Thanks Neuro. I was also wondering what you thought the chances might be for the FDA to come back with a response prior to the 60 day period? (I assume that 60 days is the usual turnaround/response time). Thanks.
MarketFest, But a few hundred shares won't get me that Ferrari will it :o)
I realize I'm late to the party, but I figure there could be a pullback/consolidation, so I'll spread out my purchases over the next month or so. There should be another double here if all goes well with the FDA.
Oh well, I figure I'm heading toward dumpster dudedom anyway, so I might as well take one last shot at something better. Once the stock gets into the $3s however, I doubt I'll be doing any additional buying. It's going to be a tense couple of months.
Just to warn you guys, I picked up a couple thousand shares today, so it's probably safe to assume that a correction is at hand :o) Next week the bulk of my funds will be ready, so I'm actually hoping for some kind of near term pull back.
I guess the overall market might become a factor if the Dow breaks below 12000, but I haven't really been following what's going on there.
WMG2, Good question. Not being a neurochemist, I'm not sure, but if the bond was irreversible then the Ampakine's effect (inhibiting receptor deactivation and/or desensitization) would presumably never wear off. Since it does wear off, one would have to assume that the bond is reversible.
Another alternative hypothesis would be that even if the Amapkine was irreversibly bound, its effects could wear off via a feedback loop phenomenon, similar to what happens with BDNF upregulation. The problem with that theory is that with all the receptors forever bound up with Ampakine, there would be no new receptors available for the next day's dose to produce their effects, which clearly doesn't jive with reality.
So one would have to conclude that the bond must be reversible. I assume that would make Amakines similar to other small molecule neuro related drugs out there, whose effects wear off after a certain number of hours presumably because the drug dissociates/separates from the receptor site. If Neuro is out there, I'm sure he could better explain how this works.
As we know though, Ampakines do possess the added characteristic of BDNF upregulation (in addition to their direct short term effects on receptor deactivation/desensitization). So even though the Ampakine is no longer present/receptor bound, it continues to have long lasting effects on BDNF production for several days. So any "side effects" related to the presence of the BDNF would
also continue on even though the drug itself is no longer present. Fortunately though, this kind of "side effect" would be the beneficial/desired therapeutic effect of BDNF (neuroprotection, neuroregeneration, neurogenesis, etc).
Addendum - Now you've got me wondering - does a drug's halflife mainly reflect - 1) the time for it to dissociate/separate from the receptor site, 2) the time for it to chemically break down in the bloodsteam and be cleared/metabolized by the body, 3) the time for the receptor to become unresponsive to its effects (feedback loop), or some combination of 1,2,3 ?
Neuro, Yes, we look to be in excellent shape. I'm just hoping I can manage to get onboard in the $2s.
It definitely would be great to have some type of convertible out there in California though. I'm not that familiar with the newer Aston Martins, other than they are priced way out in the stratosphere. I knew several people who had various Italian cars from the 1960-70s though - Ferraris (365 Boxer, 246 Dino, 308 GTB), Maseratis (Bora, Merak), and a Lamborghini (Countach). The best I could do personally was a used Fiat 124 Spyder back in the late 70's that I found for $700 :o) That was a fun car, even though it was underpowered and had rust problems, and finally left me stranded on the interstate late one night. I came close to buying a Volvo P-1800 back then, and wish I had since they are not only very cool but are now highly collectible. They only came as hardtops however. Well, if I somehow manage to score semi-big with Cortex over the next couple months, perhaps there's a new Saturn roadster in my future, or else the Pontiac Solstice version. I think these both go for around $25,000.
Neuro, >> But this is giving this matter way more time than it is worth to me. <<
Yes, no sense wasting time talking shop when you could be tooling around California in that new Aston convertible :o) Just kidding Neuro, you deserve a break once in a while from the tedium of biotech. I'm only upset because I haven't gotten mine yet (convertible that is) :o)
MarketFest, Wow, Cortex is up on a really bad day for the overall market. See, I can upbeat, well sort of :o)
Actually, once I have some shares I'll probably be as rosy and bubbly/optimistic as Neuro. There's nothing quite like making huge stock profits to change one's outlook. If I didn't know better, I'd suspect that Neuro has been out shopping for an Aston Martin, based on the numerous car references in his recent posts :o) Ferrari is the way I'd go. Or maybe one of each..
Oh well, all I can do is sit on the sidelines and watch. I should have a small portion of my funds ready within a couple days though. Just in time for the collapse no doubt..
Neuro, Listening to Dr. Lynch's presentation last year, the impression I got was that his new high impact approach is their "Plan B", and probably the approach that they'll go with, because Cortex has presumably not been able to adequately overcome the same excitotoxicity type problems that other companies have experienced. There's nothing to stop Servier or anyone else from trying the same thing (commercializing it may be another story). The approach is relatively simple, and minimizes any side effect shortcomings present in any given compound. Will it minimize them enough? We'll have to wait on that one.
In describing his new approach, Dr. Lynch said, paraphrasing - - "just imagine what this would do for the safety profile of these high impact compounds". What the intermittent burst dosing approach does is to vastly minimize the time the drug is in the body. That's what improves the safety profile. The period is so short that the drug doesn't have time to create the usual excitotoxicity. But it's long enough to set the neural/genetic machinery in motion cranking out BDNF, which then provides the long term benefit An otherwise excitotoxic compound (and all high impacts are to some degree) might conceivably have its safety profile improved enough to make it viable. Of course the other key advantage is that intermittent burst dosing circumvents the feedback loop phenomenon. So it's the ideal solution to the main challenges facing the high impact approach (excitotoxicity and the feedback loop)(I was also going to add calpain/spectrin to that list, and the burst dosing approach should help minimize the potential for that also).
Dr. Lynch's research shows that in animal models at least, ultra short burst dosing is sufficient to stimulate significant BDNF production. This is big news, because otherwise there seemed to be a growing perception that the high impact approach might ultimately be doomed to failure. It's a lot less of a long shot now.
Neuro, It's not like there is some new short term release technology that has to be invented. All they do is give an ultra short acting high impact Ampakine infrequently. So it's mainly a new dosing regimen, not anything exotic with the compound. Compound-wise, the chief requirement is that it have an ultra short halflife, and there are presumably plenty of those compounds already. The trick in the past has been to try to engineer the longest halfife possible. That's still desirable for low impacts, but not needed/desirable for high impacts using Dr. Lynch's new dosing approach. Anyway, this may open the door wide open for AMPA upmodulators that wouldn't have previously been viable.
Neuro, So what you're saying is that it's only the lack of suitable compounds that can prevent Servier from advancing Ampakines for neurodegenerative diseases, as opposed to anything relating to the ownership of those rights?
A problem with the assumption that Servier doesn't have any suitable compounds is that the proposed solution to the high impact dilemma according to Dr. Lynch is ultra short pulse dosing. Such an approach should theoretically make the side effect problems found with most high impact compounds moot. The pulse dosing approach could give new life to high impact compounds that would never have been usable using regular long term dosing. Using this new dosing method, even Servier's own benzothiadiazides or Lilly's biarylpropylsulfonamides might be given a new lease on life. And Servier has some Cortex co-developed benzamide type high impacts as well.
Aiming, board, Anyone know what the red cross inside the yellow rectangle signifies on today's chart (the high tech chart on this I-Hub Cortex main page)? Thanks.
..Now it changed to a red line/rectangle in a yellow box. Does the yellow signify anything in particular? The previous daily charts have been either green for up days or red for down, sometimes in solid color, and other times only the borders solid. I guess I should take a course in charts/technical analysis :o)
Here's the full article on Schering -
>>> Schering's Risky Growth Gambit
The pharma's $14.4 billion deal to buy Organon BioSciences represents a big bet on the tricky schizophrenia-drug market
by Sonja Ryst
Schering-Plough's (SGP) Chief Executive Fred Hassan has steered his company through an impressive turnaround in recent years, but the Kenilworth (N.J.) pharmaceutical outfit's fate remains pinned to its cholesterol drugs Vytorin and Zetia. Now, in an effort to keep the business growing, Schering announced a deal on Mar. 12 to buy the Organon BioSciences unit of Akzo Nobel (AKZOY) for around $14.4 billion. Hassan is buying several advanced-stage drugs from the Netherlands-based company—along with plenty of risk.
To be sure, Schering is also picking up nearly $5 billion in annual revenue generated by Organon businesses ranging from women's health to animal vaccines. Once the deal closes by the end of 2007, it's expected to start adding about 10¢ per share to Schering's earnings in the first full year, excluding things like acquisition-related costs and accounting adjustments. The company thinks it will begin to save $500 million annually by 2010. "Organon BioSciences will be an excellent fit with Schering-Plough—strategically, scientifically and financially," Hassan said in a press release Mar. 12.
Organon's experimental drug Asenapine, for schizophrenia and bipolar disorder, is fighting to establish a presence in a market that is rife with challenges. In November, 2006, the New York drugmaker Pfizer (PFE) pulled out of a deal to co-develop Asenapine with Organon after mixed results were announced from clinical trials. Meanwhile, critics are blasting companies such as Eli Lilly (LLY) and Johnson & Johnson (JNJ) for marketing their antipsychotic drugs too aggressively.
Others are encouraging doctors not to assume that it's best to prescribe the newest drugs; the National Institute of Mental Health announced a study on Dec. 1 showing that the older antipsychotic drug perphenazine was not only cheaper, but also just as effective as its newer rivals.
"We'll take a closer look at the drugs in Organon's pipeline, but we're not overly enthusiastic about some of them at first glance," said Morningstar analyst Heather Brilliant in a Mar. 12 research note. She pointed out problems such as Asenapine's "rocky clinical data."
Schering spokesman Steve Galpin counters that the company did not do the deal because of one pipeline compound, but rather "because Organon will be an excellent fit." He adds that Asenapine represents an opportunity for the launch of a product in the near term that could fill a high, unmet need.
It's true that Organon has many drugs that recently moved into advanced stages of development, such as the insomnia-fighting compound Esmirtazapine, the infertility hormone ORG36286, and the oral contraceptive NOMAC/E2. And Organon's Sugammadex, a drug used in anesthesia, is expected to be filed for approval in 2007.
But some are dubious. "Most, if not all, of these products are likely to be modest in size," said Prudential Equity analyst Tim Anderson, MD, in a research note.
Investors may have taken a mildly positive view of the deal. On Mar. 12, Schering's stock price was edging ahead by 0.6%, to $24 per share.
Organon aside, Hassan already has his hands full. He's staked his company's success on Zetia, which prevents absorption of cholesterol in the intestine, as well Vytorin, which blends Zetia with Merck's (MRK) cholesterol blocker Zocor. The combination pill will be under patent protection through the middle of 2015 (see BusinessWeek.com, 7/26/04, "Hooked On the Cash from Cholesterol"). So far, Schering's venture with Merck has been a boon for the company—it booked equity income from the venture of $1.46 billion in 2006, up from $873 million in 2005, according to Standard & Poor's. (S&P, like BusinessWeek.com, is owned by the McGraw-Hill Cos.)
But competitors are swarming. The generic version of Merck's Zocor hit the market last year, bringing on the threat of slowing sales for Vytorin and Zetia. Schering has still managed to grab more customers recently, but the war for dominance remains far from over. Combined sales of Zetia and Vytorin accounted for close to 17.9% of U.S. cholesterol drug sales as of December, 2006, up from some 11% in July, 2005, according to S&P's estimation based on IMS data. Meanwhile, Merck and Schering face formidable foes: Pfizer's Lipitor could have generic rivals as early as 2011 and AstraZeneca (AZN) is struggling to establish its own cholesterol drug Crestor.
Luckily, Hassan seems to enjoy the feeling you get from standing on the edge of a cliff. Soon after he took over as CEO of Schering-Plough in 2003, he said, "I like adventure, and I like a challenge" (see BusinessWeek.com, 6/23/03, "Schering's Dr. Feelbetter?"). If so, he'll have much to enjoy in the months ahead. <<<
Neuro, How can you be sure that "none of them are ever going to be developed for neurodegenerative disorders"? As I recall, the research collaboration between Cortex and Servier was primarily for high impacts, and there was one compound in particular that came out of that collaboration that was highlighted in a press release several years ago. It was reportedly 1000 times more potent than CX-516 and neurotrophic (I had jokingly dubbed it the "Owsley acid / monster compound"). What would prevent Servier from advancing a high impact compound like that for AD or Parkinson's?
Daviddal, I would probably guess around 6-8 years to approval for ADHD. Figure 1 1/2 years for Phase 2bs, then 3-5 years for several large Phase 3s, and then 1 1/2 years to get through the FDA. I assume they would go for approval in adults first.
Myostrain, Here are the five phase 3 programs. The press release also said that Organon has revenues of approx $5 bil annually from their approved products, including their animal related franchise -
>>> -- Asenapine, a novel psychopharmacologic agent for the treatment of patients with schizophrenia and acute mania bipolar disorder;
-- Sugammadex, for the reversal of neuromuscular blockade induced during surgical procedures;
-- NOMAC/E2, an oral contraceptive product containing nomegestrol acetate, a novel progesterone, and estriadiol, a natural estrogen;
-- ORG36286, a long-acting recombinant follicle-stimulating hormone for infertility; and
-- Esmirtazapine (ORG50081), for the treatment of insomnia and potentially for hot flashes in menopausal women. <<<
Here's a link to their full pipeline -
http://www.organon.com/innovations/pipeline/index.asp
Below are Organon's approved products -
Andriol® testosterone undecanoate Gynecology: Hormone Therapy
Cerazette® desogestrel Gynecology: Contraception
Desogen® (US) desogestrel / ethinylestradiol Gynecology: Contraception
Esmeron® rocuronium bromide Anesthesia
Follistim® (US/Japan) follitropin beta Fertility
Gracial® desogestrel / ethinylestradiol Gynecology: Contraception
Implanon® etonogestrel Gynecology: Contraception
Laurina® desogestrel / ethinylestradiol Gynecology: Contraception
Livial® tibolone Gynecology: Hormone Therapy
Marvelon® desogestrel / ethinylestradiol Gynecology: Contraception
Mercilon® desogestrel / ethinylestradiol Gynecology: Contraception
Norcuron® vecuronium bromide Anesthesia
NuvaRing® etonogestrel/ethinylestradiol Gynecology: Contraception
OncoTice / Tice BCG BCG Urology
Orgalutran® ganirelix Fertility
Orgaran® danaparoid sodium Anesthesia
Ovestin® estriol Gynecology: Hormone Therapy
Pregnyl® human chorionic gonadotropin Fertility
Puregon® follitropin beta Fertility
Remeron SolTab® mirtazapine Neuroscience
Remeron® mirtazapine Neuroscience
Riselle® 17ß-estradiol Gynecology: Hormone Therapy
TOF-watch TOF-watch Anesthesia
Zemuron® (US) rocuronium bromide Anesthesia
Davey, >> $20/share really an impossibility over the next 12 months? <<
$1.2 bil market cap? Yes, that's not going to happen any time soon IMO. But $10-12 ($600-700 bil mkt cap) in a buyout war with multiple BP bidders wouldn't be impossible. It isn't likely but you never know. The stock could realistically get to $6-8 this year though, which would make most everyone very happy.
I wonder what will become of this Org-24448 study once Schering owns Org-24448 (farampator)? The "ATP Group" list it as an upcoming study, so I don't know if it was ever started. It looks to be completely different from the NIMH/TURNS trial, though both are combination therapy Schizo trials. One would assume that Organon must have given their consent for this trial, though perhaps that was given during the period when it looked like the TURNS trial wasn't going to happen -
http://www.pacificneuropsych.com/espanol/research.html
>>> ATP Clinical Research, Inc.
3151 Airway Ave
Bldg T, Ste 3
Costa Mesa, CA
Tel: 714-277-4472
Fax: 714-545-5748
Upcoming Studies
A multi-center, randomized, double-blind, fixed-dose, efficacy and safety trial of farampator (250 and 500 mg b.i.d) vs. placebo as augmentation therapy in schizophrenia subjects currently receiving risperidoe (2 or 3 mg b.i.d.) <<<
MarketFest, I'll let you guys know what moves I make so you can do the opposite. Do that and you will prosper :o)
Oroadrunner, DARPA had some interest in CX-717 and ran a Shift Work type trial, but the results weren't what they were looking for, so they're no longer interested. DARPA apparently wants something with more of a kick, like amphetamines, which is the current "go pill" the military uses. CX-717 provides a more modest Provigil type effect for the Sleep Related/Shift Work indications. DARPA reportedly allowed their trial subjects to take cat naps during the trial, so the trial design was not ideal.
However, Cortex did run a Sleep Deprivation study in the UK the previous year, and got some promising results there. So there may be some future for those indications. But ADHD is clearly going to be the high profile indication for CX-717, since it showed excellent results in a Phase 2A study, with very strong statistical significance in both ADHD endpoint scales - hyperactivity and inattentiveness. The results were comparable to Strattera, and the clinical benefit occurred more rapidly. Also, CX-717 has shown absolutely no cardio side effects at all, unlike the current ADHD meds. Cortex needs to get the FDA to lift the dosing restrictions, and then CX-717 can continue on into larger ADHD trials.
Moose, Yes, that lag time after Roth was interesting. I figured it may have been due to the overhang from the recent PIPE, plus Wall St doesn't follow Cortex like we do and it took them a while to catch on to what Stoll said at Roth. It was frustrating to watch since for several hours the next day one could have loaded up big at $1.20-1.30 no problem. I thought there was a fair chance the electron microscope would show some early cellular changes, but I should have at least had the funds in place and ready just in case the results were clean. Big oversight on my part.
I'd say the pre-decision "easy money" move still has a way to go before running out of steam. I'm figuring it stabilizes into a trading range somewhere in the $3s and goes sideways for a while. I missed the boat bigtime, but my funds will eventually be in place just in case there's a pre-decision shakeout opportunity or something. I've decided not to be long through the FDA decision period though, at least not with much. The ~15% meltdown scenario is still there for the FDA decision, regardless of what our hopes/expectations are. With my luck, having missed the easy triple from $1.20 to $3.60, I'll catch the 70% collapse. That would just about cap off my illustrious career as a stock speculator.
Daviddal, Yes, considering the overall optimism, I would guess pre-decision range around $3.50 anyway. Unfortunately, the risk/reward at that level is beyond what I'd be interested in.
Erik, It looks like Neuro is figuring the odds of a good FDA decision at approx 80-90%, which is where I'd put them also. Would you care to go on record with a prediction?
I'd also be interested in your current "stocks of interest" list. I assume you still like Medarex? I've always considered them a core holding also. I remember you always had interesting stock ideas, including Cortex when it was really obscure.
Aiming, Ampakines are also noted for improving olfaction, so there is always the drug sniffing dog market :o)
Erik, So maybe we were better off with the devil we knew? I can't imagine Schering being any slower than Organon though. Of course it would have been better if an AMPA oriented BP had bought Organon. As we know, the list is growing - Lilly, Glaxo, and more recently Sanofi Aventis had some AMPA upregulation patents, plus Merck might conceivably be entering the picture.
Hope you are still doing your annual bike trips. I was in Scotland last Fall (non-biking). Will hopefully be getting into Scandinavia one of these years to explore Norway and Sweden where my ancestors were from. Good to see you still interested in Cortex.
Dew, Yes, thanks for the link. BTW, just wondering if you are you doing any nibbling on Cortex? We may need some of those high tech goats for sacrificial purposes as we get closer to the FDA decison :o)
Hi Erik, Asenapine is apparently a dog, and Pfizer bailed on it. Organon has $5 bil in other ongoing revenues though, so I guess a $14 bil price tag for the company isn't too unreasonable even if Asenapine flops. I wonder if Schering will try to get out of the NIMH/TURNS committment?