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That is one of my primary concerns as a shareholder beyond demonstrating adequate efficacy in RD.
Insider buying or insider belief does not guarantee sustainability (check LUM, Luminent Mortage which touted minimal subprime holdings, I think American Home Mortgage may have had some insider buys too, that one could be a hard one to find a quote on).
The negative side is never R+Rs 0.30 but it is always zero, that being said I am amazed at how many other companies have been able to go on fumes for quite some time. Callisto Pharm (kal) is one of those.
Current cash is one primary reason I don't buy more shares and one reason which makes me think to take some profit if the sp rises before RD results could come out but call me a shareholder who believes in the pipeline.
CX 717 demonstrated good small study results, animal studies extremely interesting, pharmacodynamics interesting, if more potent products are in the pipeline and demonstrate better safety profiles (or better testing procedures to reduce postmortem histological changes) then it should be easy for Cortex to get a partner with or without good RD results. That would be likely sufficent leverage for achieving financing( if inadequate cash comes from the deal), from the partner or from a financial institution.
Negative RD results would be a negative on the partner financing and a short term negative for the sp, reduced home run potential but greater potential for a future buyout+hopefully shares of the partner company.
There is a bigger negative of inadequate business aptitude if RD results are negative, the unwavering of "our pipeline" does not deserve to be partnered at a price below "our perceived worth". Then the current shareholder sp value could be zero.
The recent options have a deadline of 2018, I'm sure for the options they have in place already, they still have a few years before they need to be used.
For Roger, Maria, Mark, James and any other Cortex employee with options, or just each Cortex employee, I prefer they make smart decisions with their work and with their retirement plans. No matter what opions or values they may hold on Cortex and its future, it would be reckless for many of the shareholders of Cortex to be buying bundles of stock, that would indicate the possibility of similar thinking with their work which would not be good for the future of Cortex. If anyone thinks Roger et al. was at fault for inadequate planning and execution in the past year, I would not want to imagine what type of strategy and how it may be implemented if they were reckless in their plans and irrational in their execution.
The multiple buys in excess of 30k no matter what the size are nice positive signals which do not mean good results but does mean positive belief and maybe more rational investment decisions.
Options, if you have 200k options for 1.30 and 200k for 0.57, and they were due 2016 and 2018, what makes better business sense, to take those options now or when the sp was around 1.30-3 and keep them during the slow or down times or to take them at some point in the future when the sp is much higher. Why not have your money work for you now and wait for the right time to have the options work, the exercise price will always be there until the deadline.
The negatives: if cortex is bought out, I'm sure the insiders will have compensatory parts to the deal. If cortex may go under, you'll probably see greater annual increases in salary as a prelude.
Interesting article from ESPN. ampakine? crash cart? ramifications? sure would be nice for notice that a certain trial has started and is ahead of schedule.
DALLAS -- The wife of former Dallas Cowboys running back Ron Springs is suing two doctors she accuses of letting her husband slip into a coma last October, just months after a new kidney donated by ex-teammate Everson Walls appeared to save his life.
In a malpractice lawsuit, Adriane Springs (left) accuses two doctors of letting her husband, former Cowboys running back Ron Springs, fall into a coma.
The medical malpractice lawsuit filed Tuesday in state district court by Adriane Springs seeks unspecified damages and describes Springs as being non-responsive and incapacitated.
Adriane Springs said her husband has brain damage and didn't know if he would recover.
"My husband was doing so well after the kidney transplant," she said. "This is just a very tragic outcome."
Named in the suit are Dr. Joyce Abraham, Dr. David Godat and the Texas Anesthesia Group. They could not immediately be reached for comment.
Adriane Springs announced the lawsuit in the Dallas courthouse alongside Walls and her son, Shawn Springs, a cornerback for the Washington Redskins.
Adriane Springs said her husband is able to open his eyes and breathe on his own, but has little movement and cannot speak.
Ron Springs appeared to have been improving after the February kidney transplant, the first between two former U.S. professional athletes. Springs suffered from Type 2 diabetes, which forced the amputation of his right foot.
"The lawsuit is extremely justified," Walls said. "If you would have seen Ron the night before surgery, you would have been pretty impressed."
Springs, 51, underwent surgery again on Oct. 12 to remove a 2-centimeter cyst on his left arm, a procedure that relatives believed would be routine.
But the lawsuit alleges that Springs began having difficulty breathing as he received anesthesia, and that doctors used drugs to induce him into a paralyzed state in order to insert a breathing tube. The intubation failed and Springs went into cardiopulmonary arrest before being resuscitated, according to the suit.
Springs does not respond to verbal commands, the suit said, and is in a "persistent mentally and physically incapacitated state due to severe anoxic brain injury."
Les Weisbrod, Springs' attorney, said the coma had nothing to do with the kidney transplant.
The kidney donation had quickly became a national feelgood story last year. Walls was not only Springs' ex-teammate and best friend, but also his youngest daughter's godfather.
In the months following, Springs' once-ashen face again flushed with color and his muscles grew stronger.
In an August interview with The Associated Press, Springs said he was improving and that "If I can get back to 90 percent, I'd be happy." He said he was doing stretching and lifting exercises three times a week, and was optimistic about attending Redskins games to watch his son play.
Springs played eight modest seasons in the NFL -- six with the Cowboys and two in Tampa Bay -- before retiring after the 1986 season. In the four seasons Springs and Walls played together in Dallas, the two forged a strong friendship.
Last summer, Ron and Shawn Springs visited several cities in a campaign to increase awareness of diabetes. In September, Walls testified in Washington before a House subcommittee on behalf of an organ donation bill that would give grants to states' organ donor programs and track the long-term health of people who have donated organs.
Earlier that month, Walls and Springs served as honorary captains for the Cowboys' season opener, giving them a chance to raise awareness about their new Gift for Life Foundation. The foundation aims to educate people about ways to prevent chronic kidney disease and dispel myths about the living donor process.
Interesting article. Sure would be nice for a good RD drug to be available
New York Times
Aetna to End Payment for a Drug in Colonoscopies
By BARNABY J. FEDER
Published: December 28, 2007
Correction Appended
Aetna, one of the nation’s largest private health plan managers, is the latest insurer to clamp down on the use of a powerful anesthetic during an increasingly common form of colon cancer screening.
The company will send a letter to doctors on Friday, saying that it plans to classify the drug as “medically unnecessary” for most such procedures. As of April 1, Aetna plans to stop paying for its use in those cases.
The change by Aetna covers about 16.6 million members and comes on the heels of similar moves last year by WellPoint and six months ago by Humana. Other insurers say they have no plans to follow their lead, including UnitedHealthcare, which has 26 million members. Medicare leaves coverage up to local insurers that administer its plans, most of which cover the anesthetic, propofol, only in high-risk cases.
Critics say Aetna’s decision would be a step backward in the battle against cancer of the colon and rectum, which trails only lung and prostate cancer as a cause of cancer death among Americans, according to the federal Centers for Disease Control.
The anesthetic eliminates the discomfort of undergoing a colonoscopy, a procedure in which doctors explore the lower intestine to identify — and if necessary remove — developing tumors before they become dangerous.
But many specialists say there is scant evidence that the anesthetic helps enough to make it worth the cost. Aetna said its billing records showed that 77 percent of colonoscopy patients in the New York metropolitan area were receiving the anesthetic, compared with 10 percent or less in other regions. No data has surfaced linking such regional practice differences to better outcomes.
All three major medical associations for specialists who perform colonoscopies have published guidance statements saying the anesthetic was not needed for routine procedures.
“This is like a lot of hard-to-explain geographical variations in medical practice in this country,” said Aetna’s chief medical officer, Dr. Troyen A. Brennan.
A recent book looking at such patterns and at overuse of medical products and procedures — “Overtreated,” by Shannon Brownlee — concluded that they inflate health care spending in the United States by at least 20 percent.
With millions of colonoscopies performed each year and specialists advising all Americans over 50 to be screened, the proper use of this anesthetic could become a multibillion-dollar point of contention.
“It’s perfectly appropriate to say this doesn’t look like a good place to spend health care dollars,” said Dr. Douglas K. Rex, a colonoscopy specialist at the University of Indiana.
Propofol was originally marketed as Diprivan. It is now relatively cheap because its patent has expired and a generic version is available. But propofol is tricky because it acts rapidly and no rescue drug is available to counteract its effects if a patient begins to have trouble breathing. The Food and Drug Administration has recommended that it be administered by trained specialists who are not otherwise involved in the procedure.
As a result, most doctors want an anesthesiologist to assist them when propofol is used. That is especially true in areas like New York City, where many colonoscopies are performed in doctor’s offices. But using an anesthesiologist can add $300 to $1,000 to the cost of a colonoscopy, according to insurers.
Aetna’s policy is a slightly revised version of one it tried to introduce in 2006 but withdrew in the face of strong resistance. It includes an expanded list of exceptions where Aetna will pay for use of propofol and an anesthesiologist, including patients over 65, pregnant women and patients with illnesses that make the use of other drugs more risky.
Dr. Brennan said that Aetna believed the exceptions would cover 10 percent to 20 percent of colonoscopy screenings.
The data showing no advantage in typical screenings is “probably true,” said Dr. David H. Finley, United Healthcare’s senior medical director responsible for quality and affordability programs in the Northeast. “But we ended up after a lot of discussion last year deciding we didn’t want to intervene in the decision as to which patient gets the anesthetic,” he said.
Many doctors say that the freedom to choose the treatments used is an important principle to preserve no matter what the cost to insurers because there is little agreement on what really amounts to a medical necessity.
“The term ‘medical necessity’ leaves out psychological conditions,” said Dr. Ervin Moss, executive medical director of the New Jersey State Society of Anesthesiologists, who said patient comfort can play a role in the success of colonoscopies. A few doctors have reported that they found more polyps, which can be precursors to cancerous tumors, after they began using anesthesiologists to administer propofol.
Patients who fear the procedure often opt for less invasive screening techniques, including CT scanning (known as virtual colonoscopies), testing of feces and sigmoidoscopy (which exams less of the intestine). But those tests are less effective and do not allow doctors to deal immediately with any problems.
The propofol conflict is particularly challenging for gastroenterologists, the specialists who perform colonoscopies and other endoscopic procedures that involve snaking devices into the digestive system.
“There’s no doubt patients prefer propofol,” said Dr. Lawrence B. Cohen, a gastroenterologist in New York. Many doctors favor propofol because it can make procedures move more quickly and because patients are usually more relaxed, which can lead to a more thorough exam.
Using an anesthesiologist also shifts a potentially distracting task normally handled by the doctor or a nurse at no extra cost — administering drugs that keep the patient comfortable — to a third party. In the traditional colonoscopy, patients are given a combination of a sedative, like Versed, and a tranquilizer, like Valium.
Dr. Cohen has tried to find a middle ground with a procedure that uses small doses of propofol that he and his staff administer along with the other drugs. “It adds an extra 60 seconds to the front end of the procedure, but we’ve been doing it in our group of three gastroenterologists for six years with no complications,” he said. Data for results with 16,000 endoscopic patients, most of them colonoscopies, will be presented at a scientific meeting in May.
Such results are not surprising. While propofol has been linked to patient deaths in unrelated procedures, Dr. Rex said estimates that it has been administered “off label” by gastroenterologists and trained nurses in more than 450,000 colonoscopy screenings without a single major adverse outcome being reported.
Despite that record, many hospitals and clinics have rules forbidding the off-label use. The number of states restricting nurses from administering the anesthetic has grown to 22 from 12, said Deborah A. Krohn, a lawyer and part-time endoscopy nurse in Towson, Md., who has advised nurses and hospital risk managers about potential liability.
Specialists see no end to the two-pronged battle over whether to use propofol routinely in colonoscopies and, if so, who should administer it.
“There are so many layers of controversy and unsettled science in this it isn’t surprising we’ve struggled for so many years, and are likely to for many more,” said Dr. Alexander A. Hannenberg, an anesthesiologist in Newton, Mass., who is in line to become president of the American Society of Anesthesiology in two years.
In Dr. Stolls repley to Omb., he did not state Cortex could not do a short term AD study as did EPIX, from his reply I infered that there is not enough scientific statistical merit for the instrument that EPIX used to measure change.
The majority of people believe without doubt that of which they want to believe.
Dr. Stoll seemed to state that ADAS.cog associated with the type of study done in EPIX does not have a lot of merit, validity to it, high probably of a false positive.
The wording of the press release does not denote future successful results, and an extremely small study with many unknown details or significant variance in results does not denote any firm future successful results.
Think of Epix as a high likeliehood for having their stock price slashed when their next study results come out or maybe they have have some positive results.
As far as the pop in price, sometimes the buyers and numbers involved with creating that pop don't have as much true meaning or truth as you think it might.
There was a yahoo poll I read recently on how come turkeys aren't bred with only white meat and the most popular (80% or so) response was that it wouldn't be right to bred turkeys which have no legs.
around 10% agreeance was a guy who tried to talk about how there are different muscle fiber types, slow twitch, fast twitch, etc and there was a different amount of oxidative ability, mitochondria of which different muscle groups for different actions have different ratios and the white/dark meat is basically different types of muscle for different types of muscle work.
OT: interesting data gfp. For that monotherapy line with the average 5.7 improvement over 9 patients if taking out the two outliers of 14pts each,,if for this post they could be considered outliers, the average would be 3.3. Not too bad but it would be nice if there was more data available. Do you have any more specific details, age range and pre-post scores or #'s of improvement for the other 7.
5. Tran has not bought any shares yet. He does not need to purchase 30k shares anytime soon since he has only joined COR recently. His options start at .66
8. Not to anyone's knowledge and not is any significant likeliehood.
3. Not to any noticeable degree, not worth it to speculate on that one at this time
2. RD IND, pushing ahead in europe, suspect IND submission soon after any good information percolates, optimally 1st 2 months of 08.
ps, this board is full of COR speculators, investors, faithful in the promise of ampakines. Irrational exuberance, deniro and the FAN.
Good investing, investing for the future and managing risks does not a sizeable COR holding make.
What sound data is there that a person can have in a biotech to make it a reasonable large investment for a family, very limited income streams, all future earnings are possible earnings based on research and testing of biologic-pharmacologic hypotheses in addition to competitiveness and demand if a product makes it to market.
I can state with certainty that if COR ever makes it to 5+share, the insiders will own many more shares.
If you took a lesser salary compared to your peers but had substantial options to offset the difference, it would be prudent no matter the faith in the compound to wait until it is worthwhile to use the options.
Tran has 750,000 in options for 0.66, why should he significantly reduce his current living/entertainment money when he can wait for a certain time frame and possibly make millions for those options.
As much as some posters talk about the negativity of the insider holdings, why would you buy anything but the minimum shares when you have options and significant optimism. Would you reduce your spending ability for vacations, golf, vegas when you feel your options will be worth a significant amount in the future.
Here is a different view, having a majority of insiders holding near the minimum # of shares means high likeliehod that those shareholders do not feel the options will be underwater and they have no need to purchase large amounts at these low prices to try to make up any loss of income from not utilizing their options.
If Stoll mustered a buy of 500k shares currently or other significant insiders bought very sizeable amounts, they would be gambling and stating 1. we do not think our options will ever be profitable but can make some profit from the current SP 2. we are open to being blindsided by an unforeseen event, lack of rigor and procedure in testing or undesired trial/FDA information
OT Lily vs Cortex, re the GFPvsGFP debate. Peas and Carrots, peas and carrots. Certain posters comments are like a box of chocolates, you never know what you're going to get except for one where when the negatives are flying there is planned buying.
Give me the Cortex potential and maybe a year or two depending on how things go, Lily could have interesting prospects as an adjunct albeit different mechanisms and limitation (potentials) from ampakines.
1. Developmental lead exposure alters gene expression of metabotropic glutamate receptors in rat hippocampal neurons
Jian Xua, Chong-Huai Yan, a, , , Sheng-Hu Wua, Xiao-Dan Yua, Xiao-Gang Yua and Xiao-Ming Shen, a, ,
aShanghai XinHua Hospital, Shanghai Jiaotong University School of Medicine, Shanghai Institute for Pediatric Research, Shanghai Key Laboratory of Children's Environmental Health, Shanghai 200092, China
Received 31 August 2006; revised 24 October 2006; accepted 31 October 2006. Available online 8 January 2007.
Abstract
Exposure to lead in utero and in infancy is associated with a risk of impaired cognitive development. Increasing evidence suggests that the family of metabotropic glutamate receptors (mGluRs) plays an important role in synaptic plasticity and memory formation. We determined whether mGluRs subtypes 1, 3, and 7 (mGluR1, mGluR3, and mGluR7) were involved in developmental neurotoxicity due to lead. Embryonic rat hippocampal neurons were cultured for 21 days and exposed to lead chloride beginning on the fourth day of incubation. We investigated levels of mGluR1, mGluR3, and mGluR7 mRNA expression by using quantitative real-time reverse-transcription polymerase chain reaction (RT-PCR) with lead exposure at 10 nM, 1 μM, and 100 μM. Lead exposure in vitro downregulated the expression of mGluR1 mRNA and upregulated the expression of mGluR3 and mGluR7 mRNA in a dose-dependent manner. We speculate that mGluRs may be involved in lead neurotoxicity. Pathways that likely contribute to lead neurotoxicity by means of mGluRs are impairment of long-term potentiation, effects on N-methyl-d-aspartate (NMDA) receptor functions, and depotentiation.
2. Effect of Aging on Gene Expression of Metabotropic Glutamate Receptor 5 and Glutamate Transporter-1 in the Prefrontal Cortex of Schizophrenics
Hideho Shimada*1*1Department of Psychiatry, Juntendo University School of Medicine,33Department of Psychiatry, Juntendo University School of Medicine, 2–1–1, Hongo, Bunkyo-ku, Tokyo 113–8421, JAPAN, Tohru Ohnuma*1*1Department of Psychiatry, Juntendo University School of Medicine, Piers C. Emson*2*2Laboratory of Molecular and Cognitive Neuroscience, Department of Neurobiology, The Babraham Institute and Heii Aral*1*1Department of Psychiatry, Juntendo University School of Medicine*1Department of Psychiatry, Juntendo University School of Medicine *2Laboratory of Molecular and Cognitive Neuroscience, Department of Neurobiology, The Babraham Institute
3Department of Psychiatry, Juntendo University School of Medicine, 2–1–1, Hongo, Bunkyo-ku, Tokyo 113–8421, JAPAN
Abstract
Background: The involvement of the glutamatergic system in the patho-physiology of schizophrenia is attracting interest because an antagonist of N-methyl-D-aspartate (NMDA) glutamate receptor has been demonstrated to induce schizophrenic-like symptoms in normal subjects. The results of previous studies have also suggested that glutamatergic function is reduced in the prefrontal cortex (PFC) of diagnosed schizophrenics. In order to provide additional evidence for this, we investigated whether expression of metabotropic glutamate receptor 5 (mGluR5) and glutamate transporter-1 (GLT-1) in the PFC is altered in schizophrenia.
Methods: We compared the expression of mGluRS and GLT-1 by in situ hybridization in Brodmann area 9 (B9) and 10 (B10) of the prefrontal cortex in 5 normal individuals and 5 schizophrenics that were younger than in previous studies, and examined the relationship between age and mRNA expression.
Results: There were no significant differences in either mGluR5 or GLT-1 mRNA expression between the schizophrenics and controls, however, there was a significant correlation to increase mGluR5 mRNA levels in the schizophrenics in both layer III and layer V of B9 with age, a finding not observed in the controls.
Conclusion: The results suggest that the brains of schizophrenics may be vulnerable to aging and that the glutamatergic dysfunctions previously reported in schizophrenics may be partly explained by the aging process.
3. Gene expression of metabotropic glutamate receptor 5 and excitatory amino acid transporter 2 in the schizophrenic hippocampus
Tohru Ohnuma, , a, b, Shosi Tesslerb, Heii Araia, Richard L. M. Faullc, Peter J. McKennad and Piers C. Emsonb
a Department of Psychiatry, Juntendo University School of Medicine 2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
b Laboratory of Molecular and Cognitive Neuroscience, Department of Neurobiology, The Babraham Institute Babraham, Cambridge CB2 4AT, UK
c Department of Anatomy with Radiology, University of Auckland, Auckland, New Zealand
d Department of Psychiatry, Fulbourn Hospital, University of Cambridge, Cambridge, UK
Accepted 29 August 2000. Available online 10 January 2001.
Abstract
A disturbance in glutamatergic transmission has been suggested to contribute to the pathophysiology of schizophrenia and recent studies on ionotropic glutamate receptors are consistent with altered glutamatergic function in the hippocampus of schizophrenics. In order to investigate this hypothesis further, the expression of two ‘glutamatergic’ markers, the mRNAs of metabotropic glutamate receptor 5 (mGluR5) and human excitatory amino acid transporter (EAAT2) were compared in the hippocampus of control subjects and schizophrenics. We examined the regional/cellular mRNA expression of mGluR5 and EAAT2 in postmortem hippocampal sections from schizophrenics and control subjects, using in situ hybridization. Regions of interests were dentate gyrus, cornu ammonis 4, 3, 1 and parahippocampal gyrus. The regional/cellular mGluR5 mRNA content was not different between the two groups. The cellular EAAT2 mRNA content was significantly decreased in schizophrenic parahippocampal gyrus, but not in other hippocampal regions. Furthermore, only in the parahippocampal gyrus, schizophrenics had a significantly increased mGluR5/EAAT2 ratio at both the regional and cellular mRNA level. The results suggest that a disturbance of glutamatergic neurotransmission in schizophrenia was not apparent using these indices in the hippocampus, but ‘hypo-glutamatergic’ neurotransmission may be present in the schizophrenic parahippocampal gyrus.
4. The role of metabotropic glutamate receptors in regulation of striatal proenkephalin [?] expression: implications for the therapy of Parkinson's disease.
Wardas J, Pietraszek M, Wolfarth S, Ossowska K
Department of Neuro-Psychopharmacology, Institute of Pharmacology, Polish Academy of Sciences, 12 Smetna Street, 31-343 Kraków, Poland.
Overactivity of the striatopallidal pathway, associated with an enhancement of enkephalin expression, has been suggested to contribute to the development of parkinsonian symptoms. The aim of the present study was to examine whether the blockade of group I metabotropic glutamate receptors: subtypes 1 and 5 (mGluR1 [?]/5), or stimulation of group II: subtypes 2 and 3 (mGluR2 [?]/3) may normalize enkephalin expression in the striatopallidal pathway in an animal model of parkinsonism. The proenkephalin [?] mRNA level measured by in situ hybridization in the striatum was increased by pretreatments with haloperidol (1.5 mg/kg s.c., three times, 3 h apart). Triple (3 h apart), bilateral, intrastriatal administration of selective antagonists of mGluR1 [?]: (S)-(+)-alpha-amino-4-carboxy-2-methylbenzeneacetic acid (3 x 5 microg/0.5 microl) or 7-(hydroxyimino)cyclopropachromen-1a-carboxylate (3 x 2.5 microg/0.5 microl), reversed the haloperidol-induced increases in proenkephalin [?] mRNA levels in the rostral and central regions of the striatum. Similarly, repeated (6 times, 1.5 h apart), systemic injections of an antagonist of mGluR5 [?], 2-methyl-6-(phenylethynyl)pyridine (6 x 10 mg/kg i.p.) counteracted an increase in the striatal proenkephalin [?] mRNA expression elicited by haloperidol. None of the abovementioned antagonists of mGluR1 [?] and mGluR5 [?] per se influenced the proenkephalin [?] expression. Differential effects were induced by agonists of the group II mGluRs, viz. (2S,2'R,3'R)-2-(2',3'-dicarboxycyclopropyl)glycine administered intraventricularly (3 times at 0.1-0.2 microg/4 microl, 3 h apart) increased both the normal and haloperidol-increased proenkephalin [?] mRNA level, whereas (2R,4R)-4-aminopyrrolidine-2,4-dicarboxylate injected intrastriatally (3 times at 15 microg/0.5 microl, 3 h apart) was ineffective. The present study indicates that the blockade of striatal glutamate receptors belonging to the group I (mGluR1 [?] and mGluR5 [?]) but not stimulation of the group II mGluRs may normalize the function of the striatopallidal pathway in an animal model of parkinsonism, which may be important for future antiparkinsonian therapy in humans.
5. Effects of the mGluR2/3 agonist LY379268 on ketamine-evoked behaviours and neurochemical changes in the dentate gyms of the rat
Auteur(s) / Author(s)
IMRE Gabor (1) ; SALOMONS Amber (1) ; JONGSMA Minke (1) ; FOKKEMA Dirk S. (1) ; DEN BOER Johan A. (1) ; TER HORST Gert J. (1) ;
Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)
(1) Department of Psychiatry, University Medical Center Groningen, and University of Groningen, PAYS-BAS
Résumé / Abstract
One of the functions of group II metabotropic glutamate receptors (mGluR2/3) is to modulate glutamate release. Thus, targeting mGluR2/3s might be a novel treatment for several psychiatric disorders associated with inappropriate glutamatergic neurotransmission, such as schizophrenia. In an effort to evaluate the antipsychotic properties of LY379268, a potent and selective mGluR2/3 agonist, we examined its effect on ketamine-evoked hyperlocomotion and sensorimotor gating deficit (PPI) in rats, an animal model of schizophrenia. We also measured the ex vivo tissue level of glutamate (Glu), dopamine (DA) and serotonin (5-HT) as well as the DA metabolites DOPAC and the major 5-HT metabolite HIAA to determine the neurochemical effects of ketamine (12 mg/kg) and LY379268 (1 mg/kg) in the dentate gyrus (DG). While LY379268 (1-3 mg/kg) reduced ketamine-evoked hyperlocomotion (12 mg/kg), it could not restore ketamine-evoked PPI deficits (4-12 mg/kg). In the DG we found that ketamine decreased Glu and DA levels, as well as HIAA/5-HT turnover, and that LY379268 could prevent ketamine effects on Glu level but not on monoamine transmission. These results may indicate that the inability of LY379268 to reverse PPI deficits is attributable to its lack of effect on ketamine-induced changes in monoamine transmission, but that LY379268 can prevent ketamine-evoked changes in glutamate, which is sufficient to block hyperlocomotion. In addition to the partial effectiveness of LY379268 in the ketamine model of schizophrenia, we observed a dual effect of LY379268 on anxious states, whereby a low dose of this compound (1 mg/kg) produced anxiolytic effects, while a higher dose (3 mg/kg) appeared to be anxiogenic. Additional work is needed to address a possible role of LY379268 in schizophrenia and anxiety treatment.
That is definitely a possibility which like many recent posts has some assumptions which follow the idea that maybe not all the appropriate actions occurred.
With the thought of Psychiatry not even looking into the six foot box or just have a cursory look, I think of the good old saying keep it simple. Too much wording or paperwork and there's the feeling someone might be trying to pull the wool over a few eyes vs. someone trying to be the scientist and extremely thorough but almost to a negative in the business side.
Here is one small box with a clear outline of the initial problem, reason for the hold, here are the reanalyzing findings and our conclusion based on the data. If you would like to have all of the information regarding any of the tests, procedures used, please let us know which ones and we will get them right to you.
If they were not able to analyze all of the pertinent information, and COR is currently continuing discussions regarding relevant parts, then I am content with some of the recent quiet period.
Anyone remember what the price target was before R+R lowered it to .30?
Marketwatch and businessweek still have a price target of 5.57, I believe they have always had a different target than yahoo finance/msn money.
Neuro, I do believe there is a possibility Cortex could run out of money. If they do not achieve good results from RD and AD and they need to do another financing. They may find it incredibly harder than last time to do the financing. Most biotechs don't make it and most of those have plenty of intelligent backers and scientists behind their pipeline.
That being said, based on the Alberta information and all of the ampakine studies done, the number and growth of prospects in the pipeline and what is known to us of them; all of the known current interest in ampakines, the known BPs with ampakine interest, the speculative list of BPs with likely ampakine interest, it seems highly likely something productive will happen.
Has anyone tried e-mailing Cortex asking about whether or not Cortex had initiated any communication during the 30day IND or after to the FDA asking for clarification of what specific toxicology finding was the concern?
If RD data is positive and/or AD imaging data is positive, depending on the specific toxicology data + 6ft box of data Cortex has, what merit could be put to a BP reactivating the ADHD IND.
As long as the science and new compounds demonstrate reasonable safety and efficacy in addition to not showing abnormal toxicology findings associated with other ampakines, having Cx 717 for ADHD really should not matter in the long run.
Based on what we know of the rest of the pipeline in addition to the attitude of insiders and ampakine interest in other companies, the recent 1+month stock price moves, R+R news, we are in a nice buying period.
The biggest question is time and money, can there be any merger/buy-out/agreement and/or new positive data to increase SP/cash ability.
If none of the above occur within a relative short time frame then based on the current credit markets and banking system, what would be the ramifications when cash reaches a red-line.
http://money.cnn.com/2007/11/16/news/economy/mortgage_losses/index.htm?postversion=2007111610
The problem isn't just how bad a pipe might it be if things don't turn out with a BP or with data, it's would a pipe be possible for Cortex at all.
" We do, however, share our comments and concerns through communications with the IND sponsor. FDA does not traditionally send application reviews in response to an
inactivation request but does acknowledge the inactivation."
Problem #1, Assumption that Post-denial call- Cortex in inactivating the IND gave the FDA reason to not communicate its minutes/review of the IND 30day process and denial decision.
http://www.access.gpo.gov/nara/cfr/waisidx_03/21cfr312_03.html
"c) Opportunity for sponsor response.
(1) If FDA proposes to terminate an
IND, FDA will notify the sponsor in
writing, and invite correction or explanation
within a period of 30 days.
(2) On such notification, the sponsor
may provide a written explanation or
correction or may request a conference
with FDA to provide the requested explanation
or correction. If the sponsor
does not respond to the notification
within the allocated time, the IND
shall be terminated.
(3) If the sponsor responds but FDA
does not accept the explanation or correction
submitted, FDA shall inform
the sponsor in writing of the reason for
the nonacceptance and provide the
sponsor with an opportunity for a regulatory
hearing before FDA under part
16 on the question of whether the IND
should be terminated. The sponsor’s request
for a regulatory hearing must be
made within 10 days of the sponsor’s
receipt of FDA’s notification of nonacceptance."
Cortex "Cortex Pharmaceuticals, Inc (AMEX:COR) was informed on Wednesday, October 10, 2007, that the Food and Drug Administration (FDA) would soon be sending it formal notice that the agency would not approve Cortex’s Investigational New Drug Application for a Phase IIb study of CX717 in attention deficit hyperactivity disorder, or ADHD. The denial is based on results of animal toxicology studies filed by Cortex. As a result, the company has requested that the Division of Psychiatry Products (DPP) of the FDA inactivate its IND Application for ADHD.
The company has chosen at this time to not formally withdraw the IND Application in order to evaluate the formal response from the FDA. It will weigh the potential for providing additional data if the potential exists for re-activating the IND at a later date."
With a more thorough search through the FDA website, either during the 30day IND review period or shortly after the decision, there are multiple areas which give credance that the FDA needs to disclose the minutes/correspondance which should include specific aspects of the animal toxicology in question.
Since cx717 is the primary compound in the pipeline, there should have been active communication b/w Cortex (active communicating) and the FDA during the 30day IND review but also post-denial.
It appears the FDA can utilize findings from other similar acting compounds- ie if Lily had an ampakine which induced seizures and demonstrated similar location/type of animal toxicology findings then that could be one plausible reason for the FDA action.
I find it hard to believe Cortex would be passive during the 30day IND period and post-denial, not initiating any questions or asking clarification.
Insider buys;
Coleman 11/7/07 40k, 11/12/07 42k. Total held 171k
Carl Cotman 11/14/07 3k. Total held 71k
Ross Johnson 11/14/07 30k. Total held 30k
Peter Drake 11/14/07 50k. Total held 50k
Individual purchases: 5.
Number of Insiders: 4
Number of Insiders accumulating only required shares: 1
The information from Dews' post stated 30k shares are required to be held by executive officers.
Ross Johnson-only bought required, nothing significant by purchase except possibility of Ross feeling the SP is near a bottom.
Cotman- 3k buy, total 71k. Probably has a family, maybe kids-saving for college. Note: I-hub board investing style is not typical and not one of the recommended investing methods. No matter the belief of a positive future, a 3k buy with a 71k total holding is a significant buy. 3k is small but it may mean Cotman and/or his wife are rationale and no matter the faith in the future COR SP, the kids/family future investments can not deviate towards an imbalanced/volitile portfolio.
Drake- 50k, total 50k, 20k over minimum. Very positive. There is no multiple level minimums based on position. We would have access to concrete information stating such, we do not, we have concrete info regarding a 30k minimum for all executives. $10k is a significant amount of bonus/money that could be used in many other ways investing or spending on home/family.
Coleman- doubled his COR portfolio from 89k to 171k. Ie. already far past required holding.
There is absolutely no company money that was used to directly buy the shares.
The only connection is they are insiders and work for Cortex therefore they get paid by Cortex (unless they have a 2nd job, any purchase they do is "funded" by Cortex)
Only 1 Insider bought just the required holding-the only area to think here is how long has he been an employee, that could give greater positive/negative to the current buy. Ie. the required holding concept is a poor one that doesn't hold any weight for the 4 insiders who bought.
Bonuses: aren't those given after the end of the fiscal year or towards Christmas; ie end of 3rd quarter or Nov 8, 14 would not be a likely time period to get a bonus.
I don't seem to remember a differentiation with the Neurology hold and the Neurology lifting relating to short term and long term dosing, only relating to Cortex planned testing which comprised of short term testing-AD. But since we as investors have not had the privelege of reading the actual Neurology correspondance, there is that possibility.
The sudden emergence of RD, didn't that come straight out of Alberta, more of a new clinical pathway from that point of time, and since this happened recently, it is a sudden emergence but would only be an acute fallback option if there was no Alberta influence.
The FDA mentality towards lifetime ADHD drugs, you may be correct, we perceived CX717 to be very safe at utilized dosages but not enough thought was spent of the possibility of any artifact no matter what dosages in testing at nullifiying the perceived safety.
Time for a play of words which has been lightly discussed here and there;
Upon the telephone call Oct 11, Cortex "inactivated" its IND.
What does "inactivated" mean in relations to what the FDA needs to do- ie no longer needs to send a letter,, or no longer needing to follow a timeframe for the letter
Initially I felt inactivated would be the same as withdrawn, not in a hold pattern, but taken out of the process completely.
What are everyones thoughts on how we can interpret "inactivated" from Cortex and an FDA standpoint
What also could be interpretated from the time period Oct-11 to current and what from a longer time period without us knowing of a formal writtent FDA response.
The longer the time between the inactivation and any formal FDA letter from our awareness, it would seem the greater the likeliehood for correspondance to be going on and possibility of Cortex modifying its IND testing/monitoring procedures toward to something that shows the carefullness of the FDA in scrutinizing new drugs.
Wishful thinking at its worst, what would happen to the SP if news came out FDA agreed to a modified IND with CX717 with special new testing procedures due to the artificat.
It would have been nice to have a PR by now to allievate some fears, maybe a quick PR reviewing how other compounds have been scrutinized thoroughly and do not have any negative toxicologic findings but I along with probably every shareholder wants to know what to take from the formal letter in addition to what path will cortex go down.
Unfortunately it has been over a week since the news and there has been no further update from cortex, so what does that mean- the FDA felt like sitting on the letter for a few extra days/weeks-longer before sending it out. Whatever the typical procedure, if they communicated to Cortex within the 30day window does that mean that their written statement is also within a timeline or is it an open time window.
With what Dr. Stoll has spoken about earlier this year and all that has taken place since then, based on what the FDA letter would clarify from their brief ruling, Dr. Stoll may have a few options; 1. Absurdities in the letter with FDA openness towards further analysis and review; causing many drinks to flow and debating on whether or not to continue testing for 717. (The letter stating due to ratio statistical analysis being used for ordinal data,, or parametric analysis used when non-parametric data should have been, the additional tissue analysis results are invalid)
2. Whatever/however the information is stated in the letter it takes several drinks and drafts to identify for cortex and shareholders what can be learned and utiized to ensure no similar setbacks are occurred in other compounds.
As far as a Cortex goes, they have a very young but promising pipeline but it seems they are in need of a buyout with shares offered vs. cash.
Thinking out loud-Is it wise to reverse split and finance a few times to get money to trudge along-does anyone know if they would be able to qualify to actually reverse split and then finance.
One extra thought on #1. There was a post yesterday, I believe by Neuro which stated that Cortex did not redo the study finding the histology finding. All the extra leg work done was post-analysis, extra histology samples, procedural notes, analysis,,,,,,,.
Maybe the DPP division felt all of the data Cortex used to prove conclusively that the finding was a post-mortem artifact was void for an argument because of how Cortex did the extra post-hold analysis.
As far as strict statistical analysis, there are plausible negatives to what procedures they could have used, the DPP could have felt that Cortex and the "outside" analysis and consultants could analysze all the data in a way to find and give statistical credance to their hypothesis that the finding was post-mortem.
how many scientific articles/drug studies do companies perform where they didn't achieve their desired outcome but magnified other findings which the study design was not developed to properly identify in order for that article to appear significantly positive
One assumption may be that there could be some DPP personal who are extremely booksmart or dot every i, cross every t type of beaurocrat who also have that very strong desire to feel right and act/view things in a way which validates ones thinking. So they might have felt the right way to accept the finding as post-mortem would be to do the same trial again, that in addition to the indepth analysis of the initial data.
There is one more thing this brings onto the table. As far as investing in Cortex, in their platform. Management better not continue to act like they have the new billion dollor platform. There is potential but potential means nothing. They need to get a deal done, one with a reputable company which can help progress ampakines in an expediant manner.
If this company gets bought cheaply, as long as it is in shares of the purchasing company, that will be okay for me.
If the price languishes for a while, what would be the effect of additional financing in March of 2008.
It is better to be prudent than to be intelligent but with blinders on.
on an off note, lottery tickets have now been found to have a greater probability of winning to get your money back+ than investing in biotech
What a rude awakening this morning, no need of coffee at this time.
From the very initial hold to the reports this spring and the earlier lifting, what are the assumptions to be made
1. This different FDA division did not want to analyze the new 6 ft box of information and decided it's first action is based on the first events and if Cortex wants it can they slowly talk back and forth over the box of information. Makes them feel like they have demonstrated they went down the safe road in letting a new drug be developed even if it means disregarding information analyzed independently. The earth is round, brains do have plasticity in the adult, etc.
2. The psychiatric division has been manipulated by other drug companies regarding the "inherent" safety issues of ampakines
3. Cortex has manipulated their tox findings- finding different tox issues and manipulating their press releases and additional analysis to only discuss 1 tox issue and then seek low impact data dismissing it
4. The psychiatric division is itself seeking to strengthen its id
In some anticipation of no FDA surprise over the next two weeks and hopefully the ability to speed up product development in the next few months/years, this post felt a little close to home.
emageman2
Here is all about that new discovery.
GOVERNMENTIUM
A major research institution has recently announced the discovery of the heaviest chemical element yet known to science. The new element has been tentatively named "Governmentium". Governmentium has one neutron, 12 assistant neutrons, 75 deputy neutrons, and 11 assistant deputy neutrons, giving it an atomic mass of 312.
These 312 particles are held together by forces called morons, which are surrounded by vast quantities of lepton-like particles called peons. Since Governmentium has no electrons, it is inert.
However, it can be detected as it impedes every reaction with which it comes in contact. A minute amount of Governmentium causes one reaction to take over four days to complete when it would normally take less than a second.
Governmentium has a normal half-life of three years; it does not decay, but instead undergoes a reorganization in which a portion of the assistant neutrons and deputy neutrons exchange places.
In fact, Governmentium's mass will actually increase over time, since each reorganization will cause more morons to become neutrons, forming "isodopes" This characteristic of moron-promotion leads some scientists to speculate that Governmentium is formed whenever morons reach a certain quantity in concentration. This hypothetical quantity is referred to as "Critical Morass."
You will know it when you see it. When catalyzed with money, Governmentium becomes "Administratium" -- an element which radiates just as much energy since it has half as many peons but twice as many morons.
Wouldn't that be an interesting shot in the dark. The way things have perspired,,,,,transpired, an attention deficit driven management. I think GFP should be a hired company consultant.
It's been awhile since there has been some good dialogue regarding the pharmacokinetics and physiologic talk about ampakines.
Possible use in RD to AD to ADHD and more, what are the possibilities for the newer ampakines beyond their increased potency.
Would there be a therapeutic dosage related to potency needed for a specific pathology to react positively to ampakines?
What different physiologic mechanisms could different high impact ampakines have and what different physiologic mechanisms could different low impact ampakines have?
A related question, a company called upain is developing a new drug called tylenol and they have a base tylenol 1001 and a tylenol 1121 with 60% greater potency than 1001 but have a product with 150% greater potency 1911 farther in the pipeline. A deal is needed with a BP to get cash and they want to keep 1911 but deal 1001 and 1121, why would a BP want to take a molecule of the same mechanism of action which is inferior in potency to 1911.
Dew, quite the time and quality of information on your Idenix posts.
Just a few questions, your estimated cost/income analysis with rough estimate of 200m split 140/60 with Tyzeka, what would the impact be on the cost of developing the rest of their pipeline over that?
If 50-60M income per year takes in cost of Tyzeka and the burn rate continues at 60M/yr or increases as products progress/develop, couldn't a slowness in Tyzeka sale improvement cause a significant reduction in available cash and facilitate a summer of 07 cortex fund raising (very light hearted on that, I'm sure based on IDIX they would have the tools for better happenings)
Nice growth in competitor drugs and nice comparison to competitor drugs but what impact would the significant cheaper drug price in addition to the dilution of one more drug to the group for the HBV indication have?
Jim,
I enjoy reading your posts, a little bit of rarely heard old style rationale; but if I start my thoughts at a baseline, what option would have been most appropriate for Dr. Stoll to take.
For a small biotech with no income stream what are reasonable pathways to take to generate income.
Let's not put stock options into the income development stream unless you see it fit (maybe a pattern of choices, but maybe just an area of incorrect assumptions/information driving choices; unfortunately $$ and "me" drives many, scientists may fit the same but with possibly less business sauvy than desired).
Timing of this financing seems to be a primary question,
the good-all projects will be able to fire on all cylinders and the natural slow pace of drug development may seem to go a little quicker
better deal leverage- if you don't give us a very reasonable offer, we will be able to progress to the next step independently and then any offer will be in significantly higher ranges (submit IND, receive it and start immediately)
Maybe the research with the other pipeline drugs is proceding quickly and they expect a higher burn rate in the near future or are having a higher burn rate currently
the bad-with talks to the FDA, they put forth questions of the data submitted that need re-examination and the money will be needed for that time and effort
deals on the table do not appear viable and Cortex is deciding to procede on their own-to fruition/for awhile
Much of the board and myself thought the news received this summer already would have drived the stock much higher, who is to say the IND for ADHD would be any different. Since the lift of the restrictions (AD study only, no ADHD study design submitted prior to the hold I believe), the IND would seem to be a done deal with time the only factor. The FDA additional discussions may just be the appropriate political statement to go with-it takes a long time to analyze a 6ft box of data and we at the FDA currently will dot every i and cross every t.
I believe the IND is a very good step but can anyone give a thorough and valid discussion on why that would be a significant price driver for IND vs. what press releases have already occurred this summer.
Based on the overall market and the history of Cortex, maybe the only real driver in price will be- BP deal, + AD PET scan results, +pipeline data results
Why now vs. in late Sept, Oct?, beyond the leverage effect and the ability to spend more on all pipeline prospect progression, ??? is all I can say.
It might be more than what it appears. AHM, american home mortage was a good size company not too long ago. Not quite the size of the lender that matters but the amount of packages/loans they originate/deal with, the amount of assets and the pickiness of the lenders who demand a certain amount of risk hedging. doesn't matter if its good loans or bad ones, if the credit sources need more hedging then it is a better idea to not catch a falling knife.
As far as insiders go, insider buying is great but I'll also take no insider action for cortex,, at least it can let me feel like maybe there are some good things going on which they cannot act on because the rest of us are not priveledge to that information yet.
Neuroinv,
That tail wind of a resolution of Neurology's inquiry may be right, hopefully right, some investors might be waiting for that, but what in political garb is ever a clear resolution. Maybe there will be a press release stating "currently no further testing appears needed".
Avandia, celebrex, vioxx. More reasoning for a cloudy ending to the inquisition.
From what the FDA stated most recently, what would keep them from not issuing any additional statement that further trials will need special monitoring for certain symptoms or behaviors.
A CC announcing the IND and resummarizing the press releases made already/between now and then may be a good impact but but it also do nothing significant. After all, earlier this year Stoll made clear evidence pointed in their favor towards lifting the restrictions.
Weren't dealings on the table for a BP deal when the hold took place, the hold is off and in addition to all the hard work having taken place this year already, the possibility for things to happen in the doldrums of summer is there. After all, the guys on CNBC were saying that with the market downturn recently people were not going on their normal vacations :)
A BP deal would fit the timing, an IND would not, a resolution with that narrow time frame for release would not be right-better to receive the resolution information then set a date for a cc to thoroughly review it and the next steps to make.
Any good new information, a plus.
On a superficial level, I agree with your thoughts about the hold.
The initial hold placed April 2006
October 2006-hold released with limits
July 2007-limits resolved
We do not know the specifics of the initial hold beyond what information Cortex has given us
We do not know for certainity the reason for the language in the recent news, superficial speculation is not needed. Beaurocratic language by definition is vague.
At the time of the hold, the future trials were 1. PET scan AD nearterm 2. ADHD trial progression a bit farther off
I think neuro discussed the meanings of the letter and pertinent information well
It appears on a certain level that the FDA did a scan of pertinent information and gave a decision based on that, probably they did not comb through the 6ft box yet, but they wanted to make sure that they were seen as crossing each t and dotting each i.
No current hold, only dosing ceiling is the ceiling COR requested for the study. Any future study like any other drug study will need to submit requests for dosage boundaries
ADHD IND might be done timely but they might do a more thorough analaysis of the 6ft box due to the previous hold depending on how much interdepartment communication goes on.
If tendencies are to hypostulate based on feelings and past hx,my thoughts may be a little different from others
1. Cor submits the 3part package as you stated: Could the request for a meeting as well as the questions to be asked both be key strategies in case the FDA does not give 100%clearance so as to allow cortex to discuss the if needed to smooth over any hesitant/partial clearance areas. If the timeline increased due to lack of initially asking for a meeting-to meet post FDA response and lack of initially submitting questions, then,,,, I definitely bought too high at 1.55
2. FDA responds within 30-60days post receiving the package
3a. If the FDA gives all clear, a hooyah and please disregard the mtg/questions unless they may apply to other ampakines in the pipeline
3b. If FDA gives partial clearance-then extend the timeline by 30-60days for the mtg/questions and then allow time for FDA response
It seems a shorter than expected time frame is very plausible but unfortunately the longer time lines are as plausible
This has always been one of the more consistent informative message boards I have visited.
No better way to understand a biotech pipeline than to be able to converse or read bits from histologists, pathologists, doctors in various fields. Beyond the physiology,talk about stock probabilities, financial ratios and future events, that type of data I'd pay more attention to a chart guy and a lottery guide.
gfp for awhile has spoke about his CDs or interesting investment history, and I will read his investing bits like a calvin and hobbes comic strip, but I'll always take a second glance or two if he talks bioinfo.
Wasn't it Bush who said "fool me once,, shame on you,,, fool me twice,,, I can't get fooled again"
little blirb from bob and tom show.
Does anyone know all 5 of the phase III compounds in Organon? PFE it appears likely dropped asenapine due to mid-trial data points suggestive of decreased cost/benefit likeliehood. That would seem to bode well for those other 4 phase III compounds and other pipeline products potential.
Asenapine from a very superficial viewpoint would seem to be -similar to phenserine-AXYX/TPTX or many other drugs, how can you magnify "a" good finding to obscure many nonsignificant findings on more weighted data points. For those with indepth knowledge about "good finding(s), my apologies for not recognizing those here.
Without knowing the complete pipeline/other phase III compounds, the PFE dropped association and todays COR rise with Schering/Org deal would be moderately to highly correlated towards positive ampakine/faramptor studies.
Schering would have been able to have access to pipeline data of Organon to review, and the things that get stocks moving definitely felt a good increased likeliehood for COR positive association.
The value of Organon-current products-nearterm revenue increase, pipeline potential-5 phase III, several phase II products. Revenue increase is good, afterall how much money are we willing to spend for our pets-without health insurance, and pipeline drugs are as good as the studies of them as well as how close to fruition they are. As far as the pipeline, big drug companies need blockbuster potential or excellent potential with not as stiff competition for a similar drug/mech of action.
Very nice to see clear and concise positive statements, normally it is positive with conjection and misdirection and the possibility for plausible deniability. With all further tissue analysis, hopefully the coffee will be kept away from the specimens along with no student assistants in the lab.
Always great to read the comments from all who post, positive, negative, or unclear. it's easy to understand how past history of investing affects how we develop opinions, amplify certain feelings and splice bits of pieces of info to give sense to our suspicions, on an investment note, personally REITs and companies with known income/ROA/ROE/sustainability are a safe hedge from biotech with more upside vs CDs.
Biotechs are the gold mine of bipolar investment syndrome, at least in yahoo and to a lesser degree here, it feels about time for another upswing in mood, hopefully there will be continued new merit for the upswing.
T
Maybe the hope is this is not going to be the start of a descending trend in raising capital, 1.66 to 1.2x and below.
If my thinking is close to on-line, having a 35million shelf registration filed last november then having this paultry 5million deal today gives a more positive picture for the near term.
If thinks looked bad as far as out-licensing, if the tissue samples did not turn out good, I would think they would try to garner as much cash as able in the near term vs taking a small piece out at a time-this would likely lead to much greater depreciation in value.
3 guesses can be: 1. The tissue samples were not just preparation anomalies and will affect cx717, so even with a partner deal in the near-term and any income derived from it, cortex will need more cash to continue
2. The tissue samples were fine, but due to normal company paperwork and communication flows it may take a couple months to get to where a deal is inked and implemented on with cash received.
3. The scientific company governance approach is utilized, tissue samples not the best, but hope and hypotheses abound, little bit of cash for the near term in which the hypotheses will be tested, then as the hypotheses are rejected alternate ones are created and worse dilution deals happen, on and on.
One note, doesn't having a 1.66 exercise price look well on what's going on? If negatives are known inside, I'm sure the exercise price would be much closer to the current stock price.
That was probably something developed by that TV "genious" Kevin Trudeau and his amazing memory system. Sorry I threw that in, it'd be better if we kept the possibility open it was an ampakine
Where might the share price go, it is hard to argue with the great group of posters here but I do have to state a few things;
1. In the tox studies, many aspirins are equivilant to the toxic does, around 70, 75?? That must be a nutragrain size amount of a medicine, what safe medication do we have where at that dose there won't be some adverse/new effect. I'm a little rusty with pharacodynamics/kinetics but relating to binding capacity or activitation threshold or other, this sounds like a study where water is tested and the subjects have to drink 75x normal of lets say 10 glasses, what is that 10 gallons (no, but a good picture) drink that and how many subjects have cardiac effects/edema/polyuria/ or other.
2. This is a biotech which had a share price of 8.75 in 1996, 10 years ago, 10 years, surely they new that this COULD be an area with potential but also they should have known they wouldn't have a product in year 2 or 3. This industry is a snail race and the market goes by expectations of not what's current but what does the future hold. If Stoll said a pipe will be placed and they will add 50million shares to the market but next month will will have an agreement with Pfizer/whoever for 800million the price will go up.
From all remarks the bloating effect was serious and maybe caused a reduction/growth of cellular proteins to adapt to the high concentration but will reduce back to normal when taking only one bite of the 717 energy bar vs the whole bar; the area of ampakines has great potential per Stolls' remarks and has already had great interest. If dose dependency is there and it only becomes present at extremely high/sustained doses and it does not build up with smaller/mid doses to an extremely high level, then therapeutic dose/range and all other statistical analysis of that compound related to the compounds currently in use should be part of their work with the FDA.
I like the idea of the pipeline containing 3 molecules not 1, sure it may cost some money but with the growth of knowledge in this area, future potential is greater than before the hold with just one in the pipeline.
The risk for unfortunate pipes/other money draining projects is higher than what is was for the past year, but we are much closer to identifying the future potential and that will be the bigger force for stock price as long as the company doesn't say, "we've had enough, time to hit the links for good".
I did have a question about their tox studies before, why do a short term study in primates then do a long term study in rats/other? quick answer is cost but the devious answer is someone spied/hypothesized something and felt a longer primate study would show the flaw clearer while rats/other would likely not.
Here are some other companies I like, other viewpoints from this board are welcome.
exel, bivn, ptie (kal, vion more risky)