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If they don't get something done prior to April 15, don't they begin to cede control of the company to Samyang?
Absent a deal, they'll need to do another financing, and the only party that is likely to offer something other than totally toxic terms is again Samyang. At that point Samyang's stake in the company may be big enough to force a liquidation.
This may be the end of the line.
I don't dispute that. I just don't think corx's share price is as low as it is because of manipulation.
The point that I was trying to make is that it is absolutely in corx's interest to get share price as high as possible in the weeks ahead.
I don't know the context within which they are operating, but it appears that so far corx management has done nothing to support or raise share-price.
The notion that Samyang has to manipulate corx share price to keep it low is farfetched. Share price is low because nothing is happening, and no information is being shared.
A corollary to what you write is that it is in corx's interest to keep share price as high as possible leading up to the April deadline. So far, so good... I guess we don't want to peak too early.
It can only go down in the absence of news and updates. If corx is close to a deal, this silence is appropriate and will be forgotten when the deal gets done. If this silence isn't necessary, I feel that Varney should make an effort to find a venue to communicate with investors.
It can only go down in the absence of news and updates. If corx is close to a deal, this silence is appropriate and will be forgotten when the deal gets done. If this silence isn't necessary, I feel that Varney should make an effort to find a venue to communicate with investors.
Smoke signals from Varney would lead me to believe that nothing is happening. The silence from corx at least is consistent with the possibility that a deal is being finalized.
the options are to sell or wait.
Unless what we've been seeing is dead-cat-float, this upward creep on decent volume suggests that there are people out there who think a deal will get done.
I'm also happy with corx management's silence. The only reason that I can come up with for why they've sworn off even the most vapid pronouncements is that they are actually getting close to finishing a deal, and don't want to have said anything actionable beforehand.
...a sucker born every minute.
Being one, I can't dispute that argument. However many of us there are though, I don't think relying on retail investors is a viable option, particularly in a season where fear outweighs greed.
An interesting op-ed in NYT about the incentives that are shaping BP strategy :
EVERYONE knows that an easy way to save money on medicines is to buy generics rather than brand-name drugs. Makers of generics estimate that over the past decade they have saved the American health care system about $734 billion. Yet, we continue to spend more on drugs — in part because of the increasing use of so-called biologic medicines, which cost, on average, 22 times as much as ordinary drugs. In 2008, 28 percent of sales from the pharmaceutical industry’s top 100 products came from biologics; by 2014, that share is expected to rise to 50 percent.
Biologic drugs can be more expensive to manufacture; they are grown inside living cells rather than put together chemically, as conventional drugs are. But this does not fully account for their high prices. Another important factor is that they very rarely face competition from generic copies.
Congress has an opportunity to change this by including in health care reform incentives for generic drug makers to compete in the biologics marketplace. But unfortunately, both the House and the Senate versions of health care reform contain provisions that would discourage the development and significantly delay the approval of generic biologics.
The proposals before Congress would protect biologic medicines for 12 years after their approval by the Food and Drug Administration — that would be seven more years of market exclusivity than conventional drugs have. This extra protection for biologics would add billions of dollars to future health care costs.
Biologics, which include not only medicines like the breast cancer drug Herceptin and the arthritis drug Humira but also vaccines like the one that prevents HPV and cervical cancer, account for one in four new products approved by the F.D.A. For all their promise, biologics impose a heavy financial burden. A breast cancer patient’s annual cost for Herceptin is $37,000. People with rheumatoid arthritis or Crohn’s disease spend $50,000 a year on Humira. And those who take Cerezyme to treat Gaucher disease, a rare inherited enzyme deficiency, spend a staggering $200,000 a year.
The Medicare Payment Advisory Commission found that the top six biologics — including Avastin, a chemotherapy drug, and Remicade, a treatment for plaque psoriasis and rheumatoid arthritis — already consume 43 percent of the drug budget for Medicare Part B, which covers doctor visits and outpatient services. And the rate of increase in spending for biologics under Medicare Part D, the prescription drug benefit, significantly outstrips that of other drugs.
The health care reform bills passed in both the House and the Senate would delay generic competition for biologics for at least 12 years. Even after 12 years, the legislation would allow a drugmaker to extend market protection for its biologic by making minor modifications — a small tweak that would change its dosing, for example. In addition to blocking competition, this would reduce the industry’s incentive to create drugs. After all, given the option to extend protection on old therapies, why would any firm invest in new ones?
Some lawmakers in Congress say biologics need longer monopoly protection because they cost more to develop than conventional drugs do. But according to studies cited by the pharmaceutical industry’s own trade association, the average research-and-development costs of producing a biologic — $1.2 billion — are about the same as those of making a conventional drug — $1.318 billion.
At the same time, generic biologics face higher-than-normal barriers to entering the market: It costs more to develop manufacturing capacity for such products, and the F.D.A. approval process is more complicated and therefore more expensive. These barriers would suggest that biologic drugs should need fewer, not more, years of market exclusivity than conventional drugs have. In fact, when the Federal Trade Commission recently sized up the entry costs for generic biologics, it declined to recommend that biologics be granted any years of exclusivity protection.
Of course, one reason why the pharmaceutical industry would like 12 years of protection for biologics is that it would set the stage for lengthening the period of monopoly protection for conventional drugs as well. GlaxoSmithKline has already called for 14 years of exclusivity for conventional drugs.
Congress should allow biologics no more than five years of protection. That would provide drug makers plenty of incentive for innovation, and still protect consumers from the high prices that extended monopolies allow. Striking the right balance will ensure that Americans can afford the most effective medicines available.
Anthony D. So is the director of the Program on Global Health and Technology Access at Duke, where Samuel L. Katz is a professor and chairman emeritus of pediatrics.
>>> Big Pharma has recognized that it makes economic sense to offload some of the cost of research failures to bagholder biotech investors, who have a nearly unlimited appetite for chasing the promise of newfangled technologies.
Short-term sense at best. Microcap biotech is not a viable business model, irrespective of the science, because it cannot secure operating capital. Why would a VC or anybody else assume risks that cash-rich, well-informed BPs are unwilling to? Unless BP's strategic choice to off-load R&D costs is matched by a shift towards funding earlier stage compounds, BPs will be able to harvest one last round of late-stage compounds from existing microcaps, and then that's that. My sense is that the current conventional wisdom dooms all microcaps with early-stage compounds, regardless of how promising they are, because the costs associated with bringing a molecule to the point where it can be outlicenced is prohibitive.
Irrespective of how inept corx's management is (that's a topic that really doesn't interest me any more), the value of corx's IP is self-evident. If this company goes under, the outlook for biotech as a whole is bleak. The combination of short-term biotech thinking, and a disfunctional regulatory environment dooms one of the few economic sectors in which the US could still be competitive.
>>I'm at a loss to think of a deal where a BP licensed an entire CNS platform for all indications--do you know of one?
I have no expertise in biotech outside of corx, so no, I don't know of one. Based on what I've gleaned from hanging around on this board, it appears that BPs generally partner with companies whose molecules are at a later stage in the drug development process than anything that corx has to offer. If this is so the it means that any deal that cor is able to ink won't have substantial precedent in previous biotech deals to begin with. It also suggests that any deal that thay're able to make won't go a long way towards solving their problems, since the critical up-fronts are likely to be low.
The early stage of development, and the dire straits corx finds itself in would make a platform-wide low impact deal likely comparable in price to a deal for a single molecule in a later stage of development, held by a financially solvent company.
For that matter, a buyout would likely be in the same ballpark. This is probably much more likely than a platform-wide deal, and with each passing weak appears to be the obvious outcome of this whole disaster.
The momentum trading seems to have dried up. In the absence of news, we're drifting downward from here.
In a conversation I had last year with a Big Pharma BusDev group about Cortex, they referred to the "fragmented" Ampakine rights with a tone of complete dismay.
Thanks Maximalexander. The important number for me is 96 completed out of 116 sought. Based on how long it took them to get to 96, this would suggest that the trial is going to go on for a good while (1-2 months) longer.
Glass half-empty: they risk running out of funds before trial completion. Even if they are able to complete the trial, they'll have to raise funds to buy time for any outlicencing deals (unless they have everything set up ahead of time).
Glass half-full: They'd have to be brain-dead to pursue this at such expense if there was some indication of efficacy.
I suspect that they're waiting for SA results not as a strategic choice, but because nobody's interested in RD.
Does ANYONE have any information at all about anything at all going on with this god-forsaken company?
I understand the need for confidentiality, but it would be nice to know something / anything about the following:
Are any partnership negotiations ongoing?
How many subjects have participated in the SA trial? Is the trial complete? What are the target numbers?
At this point even the usual bloviation and BS would be useful, just to give us the sense that someone is still answering phones.
Do you have any sense of what's going on @ corx?
They might be able to mine for these data out of the cohort they recruited. I don't know how common opioids are prescribed for pain management in the UK, but if the trial were carried out here, they'd likely have the data.
With 20/20 hindsight, I think that corx should have targeted SA patients whose SA was caused / exacerbated by opioid use, taken to manage chronic pain. By targeting this population:
Their chance of establishing efficacy would be better (ampakines reduce opioid-induced RD, and the high prevalence of SA in opioid-taking patients suggests that their SA is at least in part due to opioid-induced RD). Also subjects in this category may have fewer other complicating factors (obesity, diabetes,...) that may result in disregulation of breathing that is not tractable to ampakines.
The trial design would have been directly relevant to the clinic. Efficacy in one night's sleep improvement is not very meaningful in the treatment of a chronic condition that is due to disregulation of homeostatic mechanisms, but one night's efficacy is clinically relevant for treatment in the context of short-term post-operative pain management. While post-operative patients are a high-risk group to try things out on, painful procedures on otherwise healthy patients are not uncommon (plastic surgery).
By focusing on opioid-induced SA, they will have set up a framework to address critical safety issues that would need to be addressed prior to being able to test these drugs as treatment of post-operative RD, and they would also butress the efficacy of this approach.
Anyway, that was now, this is then.
To summarize my past 2 posts:
Nothing's happening, because nothing's happening.
Unfortunately, I think everything hangs on SA. If an RD were doable, my guess is it would have already gotten done (it's now been ~17 months since efficacy was shown).
You're right, as others have pointed out, I was off by an order of magnitude.
All this said, it isn't the volume that bothers me, it's the price.
I don't think anything is up. At these prices, what's the point of selling? Buying makes a bit more sense, if you invest what you can afford to loose. My guess is the total amount of money transacted in corx since the beginning of the year is well below $100K. I think this is nothing but noise.
Actually, I think there is something up: cor is outperforming other penny stocks, and this is attracting investors. On a nano scale this is a virtuous cycle: people are buying because people are buying. Underneath that, there probably is some awareness that the stock is undervalued, but I doubt that most of the people who are buying are doing it for anything other than the short-term: ride it up for a week, then switch.
Has anybody bothered to do a Freto-style pincher analysis of corx?
FWIW, corx is #20 on the list of stocks wrt YTD performance:
http://www.nasd100.com/2010/02/latest-52week-high-stocks-feb-18-2010.html
dead cats do bounce, but a cat on its 9th life may bounce a bit higher.
New corx patent:
http://www.freepatentsonline.com/y2010/0041647.html
as to the creeping, at these prices and volumes, can't mean much.
No way cor is dillydallying on bad news. They can't out-wait a prospective RD partner who wants more info about SA. If SA is a dud, they will have to just move on with what's left.
Delay isn't part of corx's strategic or tactical options, even if it's the hallmark of their performance.
What seems more plausible to me is that either the data are ambiguous, and corx has contracted Quintiles to data-mine for some half-way legitimate subset of the data to present in the most positive light, or that they've just had a horrible time getting a meaningful number of people to complete the trial.
Sometimes I wonder if we are following a real company, or if we have all succumbed to a collective delusion. Preliminary results were forecast for last October!
FWIW a series of interviews w G Lynch on Dutch TV:
http://www.skills4theweb.nl/2010/01/14/gary-lynch-over-ons-brein-1/
When he starts talking its English w subtitles.
The potential conflict of interest here is obvious: if they are invested in a company that wants to acquire ampakine technology on the cheap, then they can weaken cor to that company's advantage by drawing out the trial duration. My sense is that unless cor uncharacteristically drew up a contract with performance targets for the CRO, this activity wouldn't be detectable or actionable.
This scenario is speculative, but it provides example of why allowing Quintiles to invest in the biotech companies is a bad idea.
This is jaw-droppingly bad public policy, making the conflict of interest between rating agencies (like Moody's) and the banks they worked for look innocent.
Quintiles can invest in a company's drug based on insider information obtained over the course of a trial they were contracted to do.
Quintiles can cook the outcome of a trial for its own profit, either up or down.
The notion that regulatory agencies have safeguards in place to protect against this would provide reassurance, if it weren't for the execrable performance of just about every regulatory agency out there, whether they be regulators of the financial sector, air-traffic safety, water quality, labor relations,...
Quintiles should be barred from investing in the biotech sector. They should have NO skin in the game. They should just run the trials.
I'd like to think that there's a better way to provide patients with access to treatment. This talk is about how social networking can provide efficacy data, and shed light on best practices.I wish I had known about it when I was floundering around, looking for treatment options for my cousin with ALS.
http://www.ted.com/talks/lang/eng/jamie_heywood_the_big_idea_my_brother_inspired.html
The FDA's mission needs to be rethought.
A very broad use patent for ampakines from Pfizer filed 2008, published today:
Sulfonamides and Pharmaceutical Compositions Thereof
The invention is directed to a class of compounds, including the pharmaceutically acceptable salts of the compounds, having the structure of formula (I), as defined in the specification. The invention is also directed to compositions containing the compounds of formula (I).
Here's the link:
http://www.freepatentsonline.com/y2010/0035865.html
I'd be grateful if those with the expertise could evaluate this patent in the context of cor's IP.
This looks more like poaching on LY's IP than cor's.
With the recent BP press releases of cost cutting and restructuring of R&D dollars, I'm not so sure we stand a great chance of survival here.
With the recent BP press releases of cost cutting and restructuring of R&D dollars, I'm not so sure we stand a great chance of survival here.
Another analyst's report on cor (these have been popping up more often lately).
http://www.companiesandmarkets.com/Summary-Company-Profile/cortex-pharmaceuticals-inc-therapeutic-competitors-261720.asp
You can cough up $336 dollars for the document, or just buy 2K shares for the same amount.
Your comment implies that they are going ahead with RD negotiations independent of SA outcomes. Do you know if this is the case? In other words, is a pure RD on the table with some entity, and perhaps stalled there, or is cor waiting to get SA data before moving forward on a RD/SA deal?
I think that the Varney paper that someone posted a link to here supports your thinking. Leaving aside the details (since I only glossed the ms), Varney focused on the high incidence of SA in patients being treated with opioids. I think this outlines how Varney envisions the partnership bundle. It also provides something of a hedge if the SA study outcome is muddy (likely given the heterogeneity of the subject sample). If there is anything at all in the data, they may seek to negotiate a clinical trial in which SA in post-op, opioid-medicated patients is treated using ampakines. In this group, SA events are likely common, yet not life-threatening. Testing ampakines on this patient population would finesse some of the safety issues that present challenges for an RD study, but will butress efficacy data.
So yes, probably things are on hold until the SA trial is completed. Weeks? Months?
Does anyone here have a sense as to whether an RD deal is pending, or dead?
Others appear to be getting into the Ampakine game:
AC Immune SA, of Lausanne, Switzerland, licensed an AMPAkine memory enhancer (ACI-518) from the State University of Moscow. The preclinical small molecule is designed to activate global memory function and should complement AC Immune's Alzheimer's disease drug pipeline currently focused on disease-modifying therapies of anti-Abeta and anti-tau. Financial terms of the deal were not disclosed. AC Immune also started preclinical testing with ACI-636, an oligo-inhibitor Morphomer.
http://www.thefreelibrary.com/Other+News+To+Note.-a0216841961
I'm done here for the next little while. I'm somewhat more hopeful about all this, but dithering around here isn't going to change outcomes, and I've got to focus on the things in my life over which I do have some control.
Over and out until something of interest comes up.
Provided there is no 'safety signal', Phase II testing would be allowed.
The game-plan would appear to be an IV formulation of CX-717 for RD partnered out for ~$5M to fund clinical trials towards outlicencing of CX-1739.
This is my problem: there are 2 indications that CX-1739 could be used for: ADHD and SA.
I don't think SA will pan out.
I remain leery of ADHD as an indication, for all the usual reasons (a condition affecting primarily young, otherwise healthy subjects; will require chronic use; other drugs have been shown to be pretty effective (albeit with important risks)).
I don't have a clear sense as to whether the FDA has become less (or more) conservative under Obama, but am not at all sure that CX-1739 would gain approval for phase II trials.
I think cor has staved off death for a few months, but think it still is a long shot that it will start making money for anybody any time soon.
A more conservative (to the point of pyrrhic) approach would be to outlicence the whole low-impact platform, generating enough money to bring the high impact into tox, etc. trials. I have my doubts that there would be a taker for this kind of deal though.
I've been reading a fair amount about SA, and the more I read, the less amenable it seems to treatment via a single pathway. SA arises out of the interaction between sympathetic nervous system activation, cerebral vascular tone regulation, peripheral O2 and CO2 sensing, and central CO2/pH sensing. Even if, on the off chance that SA was mitigated for one night (that's all cor's trial will yield), anybody who knows anything about the disease will not see it as very strong evidence that a useful drug is in the offing. Further, given the number of systems interacting in maintaining blood-gass homeostasis during sleep, and hence the number ways that SA can arise, patient-to-patient variability is to be expected.
Then there's the problem that ampakines counteract sleepiness...
I continue to consider SA a mistake that will lead nowhere. I don't expect it to be a factor in cor's future, unless it continues to be a sink for cor's limited resources.