Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Stoll's response to Pirros' question regarding the possibility of a merger was lukewarm at best, and he indicated that this was not something the company had much control over. Could it be that such a deal would be a money-maker for Rodman & Renshaw (i.e. could they broker the deal)? In the event of an unfavorable ruling from the FDA on CX-717, this outcome becomes more probable, I think.
I think share price is stuck where it is because somebody is selling off a boat-load of shares, at $1.90 or better.
ampakines target AMPA receptors, not mGluR5, which are part of a completely different (metabotropic) family of receptors. I doubt MPEP's effect on cultured neurons can be interpreted one way or another wrt ampakines' utility in treating fragile X.
Why would a big pharma want to "partner the whole thing"? Why not just buy cor out? I was thinking that cor might seek to spread its IP across a variety of partners as a hedge against being bought out. All this begs the question of what the final aims of the people running cor are: to bring the IP as quickly and efficiently to market, while making a lot of money (compatible with a buy out), or to preserve cor's independence and perhaps make a hell of a lot more money. All the discussion of in- and out-licencing doesn't address the cor management's level of interest in a buy-out.
The last time a CC was held after end of trading the news was bad. I hope this is just a pacific time thing.
is there any waiting period befoe which those warrants can't be exercised?
In the event of a positive psychiatry ruling, will the shares offered to Rodman and Renshaw be redeemable? What is the share price at which R&R make money on the deal? I am trying to figure out how much the share dilution will affect the eventual bounce of a positive ruling.
TIA
We're going into a one-sided binary event: if the FDA doesn't promptly approve cx-717, the stock tanks; if it approves phIIb, then the share value will pretty much stay where it is. I think a negative outcome is unlikely, so I'm happy to gamble my pants now that I'm shirtless.
It's worth noting that in the bear stearns presentation, NOTHING was said about inlicencing.
Aiming4 found the link (msg 9303)
http://www.zangani.com/files/2007-0905-orphan-diseases.pdf
Why 30%? Is the guy at psychiatry that much of a hard-ass? What are the liabilities associated with CX-717 that warrant this skepticism? Is this just a reflection about how tough it is to get anything at all past the FDA (particularly drugs of a new class)?
The Rodman & Renshaw review of companies with orphan disease drugs in their pipeline includes cor in their list of companies, but when they review cor, they focus on ADHD, which doesn't fit the orphan description, and then only secondarily discuss ampakines in the treatment of HD, which is an orphan disease, but for which progress towards bringing drugs to market is far less advanced.
I'm curious about following: if an ampakine were fast-tracked to market by targeting an orphan indication, what would keep doctors from prescribing it for other non-orphan indications for which preliminary data are promising, and for which alternative drugs are either non-existent or unsatisfactory?
If there is no way to constrain what doctors prescribe a given drug for, might the FDA not impose higher standards for an ampakine, whose applicability might be broad, even if it were being tested as a treatment for an orphan disease?
Alternatively, if the FDA is required to limit its consideration of a given drug for the treatment for which it is being submitted, regardless of the alternative uses to which it might be put, it seems to me that submitting an IND for an orphan disease would be an excellent way for cor to get its foot in the door, and essentially do an end-run around the much more stringent standards applied to blockbuster indications, for which the drug in question might be effective.
The IP of this company is jaw-dropping, and may represent a paradigm shift about how we think about brain (dis)function. Neuroscientists, like freudian psychologists, think you have to understand the problem to find the solution. The data coming out of cor suggests that this may be wrong. In a generic way, the effect of ampakines can be thought of as an improvement in the signal-to-noise ratio for excitatory neurotransmission, together with a pulse of BDNF (in the case of the high-impacts), which is equally generic in its beneficial effects. I've seen snippets of data suggesting that this class of compounds is uniquely effective in treating Parkinson's, ADHD, sleep deprivation, ..., etc. The salient, stunning commonality here across these diseases is that the cascade of events at any level of description from transcription to whole organism that lead to the disease state are irrelevant to the treatment, which is generic in its effect. To return to the analogy with freudian psychology, the ampakine platform is like the cognitive-behavioral therapy alternative to the "you-have-to-understand-it-to-cure-it" consensus among neuroscientists. Maybe you don't.
It's because of this that the miserable SP we're currently mired in doesn't worry me much. As others have pointed out, there is no reason to expect that this is going to change much anytime soon. In the medium term though (1-3 years), I think this company will do well. A range of drugs are ready to be tested in humans, and the company has the money to stay afloat until BP funds kick in.
All that's needed is one drug getting through the FDA barrier. Then ampakines as a class will have an easier time coming to market, and if their effect is as generic and beneficial as they appear to be, the user base is big.
What was completely left out of the discussion is whether, in addition to rescuing respiratory function, the ampakine also compromised the (desired) analgesic effect of the opioid. Ampakines will affect the excitability of all the neurons in the CNS, and the mechanism by which opioids disrupt pain transmission is likely the same mechanism by which they disrupt rhythmogenic activity in brainstem, so if ampakines rescue breathing, they may also restore transmission of the pain signal. The drug would remain useful in the treatment of overdosed opiate addicts, since Naloxone is a quick trip to hell for those people, and this should provide a gentler landing, but it may not be much use in preserving respiration in the context of opioid treatment of chronic or postoperative pain.
If you want to understand the physical chemistry of a molecule, don't ask for it in layman's terms. It's not possible. Whenever science gets watered down, what is conveyed is almost invariably just plain wrong, worse still people think they've been enlightened when in fact they've been misinformed. Furthermore, the structure of the molecule, to someone other than a chemist, conveys no information. To be able to put it into context, you'd need to know the structure of the AMPA receptor, and the details of how glut interacts with the receptor. None of this is reducible to "layman's terms". If the science interests you, do the work to understand. Otherwise, it's like an illiterate wanting information about fonts to get a handle on Shakespeare's sonnets.
That's my goat. Let's see if it helps.
So there's plenty of time. Let's hope we're not still on this board in 2018.
I'm not so sure. Ampakines modulate one receptor subtype (albeit the most ubiquitous receptor for glut) for one transmitter. Considering the wide range of neurochemicals coursing through our brains, and the even larger number of receptor subtypes, what's being targeted is a tiny part of a much larger system.
Right now, the promise of ampakines is that they act as a paliative or a treatment for just about every psychiatric, neurodegenerative, and developmental/genetic disorder that humans suffer from (based on the list at this website). I've seen the animal data, and it all seems to bear this out. When I step back and think about it though, it just doesn't make sense. There's a mismatch between the complexity of the system that needs fixing, and the tool being used to fix it. I think of psychiatric/neurodegenerative disorders as arising out of a disregulation of brain chemistry homeostasis, involving feedback loops that have gone awry, and or breakdown of cellular homeostatic mechanisms. In this context, the notion that ampakines will treat the diseases in that list seems to me a bit like saying that vitamin C or aspirin will treat cancer. It's not impossible that this is the case (because ampa receptors are something like a final common pathway for much of the synaptic signalling in the brain), but on the face of it isn't very likely.
What we don't know yet is how ampakines will affect glut or AMPAR homeostasis. People who abuse benzodiazepines end up synthesizing less GABA, leading to rebound and other symptoms. We don't know yet how chronic ampakine use will affect brain homeostasis, but I'm pretty sure that it will.
My sense is that the transient use of low impacts (to counteract respiratory depression; to counteract sleep deprivation-induced cognitive deficits) may be more likely than their long-term use for conditions like ADHD. I like the high impacts because their mode of administration seems to me to be less likely to lead to homeostatic correction.
I'd be extremely happy both as an investor and as a person if ampakines could prove to be beneficial in the treatment of even one or two of the diseases in that list.
From the UCI website I get the following list of patents that look relevant:
Title: POSITIVE AMPA RECEPTOR MODULATION ENHANCES BRAIN NEUROTROOPHIC FACTOR EXPRESSION
Patent Number: 6,030,968
Lead Investigator: Gary Lynch
Department: Psychiatry & Human Behavior
Issue Date: 02/29/00
Title: DRUGS THAT ENHANCE SYNAPTIC RESPONSES MEDIATED BY AMPA RECEPTORS
Patent Number: 5,747,492
Lead Investigator: Gary Lynch
Department: Psychiatry & Human Behavior
Issue Date: 05/05/98
Title: DRUGS THAT ENHANCE SYNAPTIC RESPONSES MEDIATED BY AMPA RECEPTORS
Patent Number: 5,891,876
Lead Investigator: Gary Lynch
Department: Psychiatry & Human Behavior
Issue Date: 04/06/99
Title: DRUGS THAT ENHANCE SYNAPTIC RESPONSES MEDIATED BY AMPA RECEPTORS
Patent Number: 5,852,008
Lead Investigator: Gary Lynch
Department: Psychiatry & Human Behavior
Issue Date: 12/22/98
Title: DRUGS THAT ENHANCE SYNAPTIC RESPONSES MEDIATED BY AMPA RECEPTORS
Patent Number: 6,274,600
Lead Investigator: Gary Lynch
Department: Psychiatry & Human Behavior
Issue Date: 08/14/01
BENZOXAZINES FOR ENHANCING SYNAPTIC RESPONSE
Patent Number: 5,736,543
Lead Investigator: Gary Lynch
Department: Psychiatry & Human Behavior
Issue Date: 04/07/98
Title: BENZOXAZINES FOR ENHANCING SYNAPTIC RESPONSE
Patent Number: 5,962,447
Lead Investigator: Gary Lynch
Department: Psychiatry & Human Behavior
Issue Date: 10/05/99
Title: TREATMENT OF SCHIZOPHRENIA WITH AMPAKINES AND NEUROLEPTICS
Patent Number: 6,166,008
Lead Investigator: Gary Lynch
Department: Psychiatry & Human Behavior
Issue Date: 12/26/00
Based on these start dates, when do they expire?
For what these disclaimers are worth, I'm not a rat, I just work with them. I've invested a boat-load (for me) in this stock, and am trying to do the due dilligence after the fact as usual. I'm trying to figure out when the patent expiration dates will start having a negative effect on sp.
What is the expiration date on cor's patents? TIA
Is cor close enough to the expiration of its patents that the window of time available for a BP to make money off the IP is sufficiently small to create downward pressure on any cor outlicencing deal?
Sorry for the run-on sentence.
This once-burned-twice-shy component is going to be a drag on PPS. If everything lines up as we hope, I think that the increase in PPS will be late, but when it comes will be steep. The cohort of people who are willing to invest in this stock based on the science has shrunk considerably, because these people have already been burned.
Why is a less-than-optimal CX-717 outlicensing deal considered a much worse option than a really bad PIPE? I'm not asking this to challenge your judgement, but to learn more about how these things work. I understand the science end a bit, and find that quite compelling, but the strategic issue of how to translate IP into wealth is something I am trying to figure out.
My guess is that the difference between a good and a poor outlicencing deal would be ~$20,000,000. This may compare quite unfavorably with the downside associated with the PIPE, but has the advantage that:
1. a partnership between COR and a credible BP partner would lead to shares being bought simply because of the fact of the partnership, irrespective of the science or the likelihood against an FDA approval.
2. A partnership before the FDA ruling would be a hedge against an unfavorable ruling (I'm figuring that we're not the only people who think that the phase IIb is extremely likely to occur, so even though this would be the main reason for a less-than-opimal deal, I think a BP would still consider entering into such an agreement).
3. For those who have followed this stock and have been wary of getting back in, this would begin to reestablish the somewhat damaged trust between longs and the corporate leadership, which would attract more retail investment.
I want to stress that I don't see the PIPE as anything too heinous. I'd rather have management that is somewhat ruthless in its focus on the well-being of the company than on keeping shareholders happy. Also, I feel that over the past year, with his straight-forward handling of bad news, Stoll has established his credibility. I just feel like there may be a human dimension to the choice made: the regard in which a CEO is held may be primarily a function of the deals he signs off on, so a mediocre deal is seen as a real blemish on a reputation. In the context of cor's deep IP, such a "loss-leader" deal might in the medium term turn out to be quite favorable.
I'd be curious to know what you, or anybody else who'se been tracking micro-cap biotechs thinks of all this.
NMM
You lost your own money.
>>so long as it is not a harbinger of concern regarding CX717 at the FDA.
This doesn't get much discussion because this would really be a worst-case scenario. Unfortunately, it is one in the context of which this very unfavorable deal makes sense. Based on the FDA's track record with novel drug classes, if there is anything at all that raises flags about CX-717, cor may decide to cut its losses. At this point I don't yet have the nerve to cut mine.
BP has plenty of cash on hand, and is in a position to accurately assess CX-717's chances of approval for a phase 2B trial. Raising capital by other means at this point can only be done on very unfavorable terms. This represents a change in circumstances, and might have warranted a change in priorities on management's part.
It's worth noting that not nearly as many people on this board said that a PIPE was in the works as are now saying that this was the sensible thing to do. I think that there's a certain amount of cognitive dissonance management going on.
I keep thinking of the "the pearl". If you can't let go, you wind up with ashes.
It seems to me that a less-than-optimal BP deal for CX-717 would have been preferable to raising funds by cratering share price now and diluting it down the road. Cor may not have good options, but the management could have chosen differently between the bad options it had. A less than optimal deal for ADHD trials of CX-717 would have raised SP, setting the stage for a PIPE on more favorable terms. If cor's IP is as deep as we all keep telling ourselves it is, I would have preferred a bargain deal with BP than this shakedown. If I weren't already invested in cor now, I would be extremely hesitant to buy any shares of this company, regardless of the value of its IP. If this assessment is shared by others, this deal's cost to the company may greatly exceed what we can easily calculate.
I find it hard to believe that cor was at a disadvantage when compared to the other companies you listed. Paraphrasing Talleyrand, this was worse than criminal -- this was stupid.
I don't expect a CC before September. Those of us bitching and moaning here have nowhere to go, and an end of August CC would likely be missed by everyone but the newly burned.
We have a poorly managed company at the mercy of a disfunctional agency. I have no idea where this is headed, and having lost my shirt, I am now loosing interest. I feel stupid for not having paid more attention to cash on hand. The company needed more funds, but these terms were atrocious.
My guess is that in the conference call, will either announce another PIPE, or will present the details of the neurology division's assessment of the 6' box. I think the latter's the case, since my guess is that when cor sets up a PIPE the know the time-line well enough to give an exact date for the CC announcing it.
If Neurology explicitly states that cor has addressed the concern about the histology artifact, it is not clear to me what would stand in the way of Psychiatry approving the ADHD trial, since I don't know of other unresolved issues pertaining to CX-717.
Does it make sense for COR to do another PIPE now to hedge against a negative FDA decision? Do they have the funds to bring other drugs (CX-701 for starters) through to where a BP deal could keep the company solvent? It doesn't make sense to me that COR would do a PIPE if CX-717 is approved for the ADHD study, so I'm considering the PIPE a low probability event, that if enacted, would indicate COR's lack of confidence in the outcome of the FDA decision re CX-717 for ADHD.
Neuro, which companies come to mind?
Tightening credit may also decrease the likelihood of a COR buy-out.
Do you think that at this point cor has the leverage it needs in negotiating a BP deal? Can this be initiated prior to an IND filing? Might this not be advantageous, since then the company they partner with can play a bigger role in the IND's development? Also, cor would benefit from the BP's experience with the FDA.
Thanks
The core of your argument is that the PET scan study requires one dose, hence it is plausible that the neurology division would approve dosage liberalization for that study. My sense is that if the questions about CX 717's safety that prompted the dosage restriction hadn't largely been addressed, they wouldn't allow even a one dose study to go forward. For what? If this is a drug that the regulators felt OK about on a "one-shot" basis, but not for repeated use, then why approve initiation of a study to test the efficacy of CX-717 (even on a one shot basis) for a chronic disease? That's a waste of everybody's time and resources. I'm not saying that you're necessarily wrong, but it certainly doesn't make a lot of sense.
If you're a "cautious investor", buy index funds. No matter how closely you parse news releases, there will still be unknowns. If you want to wait until COR is a safe bet, you won't be buying shares at this price.
Anybody following this board knows enough about the platform to decide whether, based on the science, ampakines are a decent bet. Most of the speculation that surrounds this company is focussed on different parsings of the terse information we are getting from the company about the FDA's rulings. We all know this is the wild card, but it really isn't that complicated: one division of the FDA has lifted the dose restriction. This was also the division that imposed the restrictions originally. It would be pretty incoherent for another branch of the FDA to maintain the restrictions, which were based on 70X clinical dose artifacts. If the neurology group buys into the artifact story, why wouldn't psychiatry? There are reasons, ranging from the improbable to the paranoid, but the bottom line is that a lift by neurology and no lift by psychiatry would be an incoherent decision. So if the science is is sound and a lifting of the dose restriction seems likely, what is going on here? People drunk on greed and/or fear. Meanwhile, for all we know, the real black swan is paddling right at us, and it probably has no relation to anything posted here.
What is the process by which we will find out about the FDA decision? A press release from COR, a conference call, or information disseminated by FDA itself?
I think that everybody's over-reacting to the delay. I'd prefer a fair review to a rushed review against a deadline, and feel that while the FDA was provided with a 6' box, the essential findings of COR's submission can likely be gleaned from a very few pages out of that box. Even though COR may be lower than other time-critical FDA priorities, they also can't allow stuff like COR's to pile up.
If the outcome is favorable, who cares about the wait, and the interim stock price.
It doesn't look to me like a bunch of small investors piling on after a story. The chart suggests that one buyer bought a huge chunk of stocks.