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Actually, now that I check my records,let me correct two things I said. Takeda and Pfizer ran Phase Ib studies--the former in adult ADHD, the latter in schizophrenia, including a ketamine model (they ran a number of Phase I and Ib trials). Takeda terminated their Phase Ib, so something must have come up re: safety (seizure?).
Pfizer ran a number of trials, so they must have been OK with human safety, the most recent one was a multiple ascending dose study in schizophrenia.Someone had told me that this program was being ended, but it is still listed on their pipeline, so it apparently has survived thus far, including a few Phase Ib trials.
Servier ran a full Phase II in patients with both Alzheimer's and depression. They havent announced the results--but it failed on efficacy. So all three of the compounds passed the animal testing/histopathology hurdle. Two ended, due to two different issues.
But Pfizer's sz program has NOT ended yet, at least not officially. Nor have they announced anything about going further into PhII, so I don't know if what I heard was wrong, or prematurely correct. If they were to go ahead into Phase II for sz, that would help with the task of resurrecting Ampakine-type drugs in the eyes of potential partners.
NP
It's not the case that all Ampa-modulating/Ampakine programs demised after the CX-717 histopath issues.In fact there has been a brief revival of AMPA-interest: Takeda, Pfizer, and Servier all ran trials in the past eighteen months (Servier is still using CX1632)--it can be safely assumed that all of them did thorough animal testing before going into human testing, and did not find tox problems.
However--all failed in PhII, Servier most recently. It is possible that, separate from the histopath issue, that companies all err on the low side of dosing because of the longheld (and not unjustified) worry about seizure-induction,and thus miss out on efficacy, but that is speculative.
The CX-1739 tox issue will likely clear up (if chronic dosing didnt cause a repetition of the issue, why would brief dosing?). But the task of finding a partner would have been infinitely easier had any of these other programs been successful.
NeuroPespective
I don't know him. But he has a track record of successful company building and transactions. The key message is that a credible guy who doesn't need the job is willing to take it AND put up $250K for stock ownership. The question now is to whether he has a network that will get him access to the funding Cortex needs. He thinks he does, otherwise he wouldn't have been willing to pay in $250,000.
NP
Unless there is something about the FDA and their view of sleep apnea that I am completely unaware of:
It's a 120pt Phase II trial, just two clinical sites. That is enough to provide data supporting a larger scale Phase III trial upon which NDA filing would be based. But I am not aware--in the neuro sector--of such a small Phase II ever having been sufficient for approval. Maybe in oncology...
There are some programs that are using their first actual efficacy trials as their pivotal trials for NDA submission: The huge Alzheimer's trials of monoclonal antibodies and BACE inhibitors, and maybe more to the point, Biogen/Isis Pharma's trial in spinal muscular atrophy. The latter is a relatively small trial, but it is in a rare, devastating genetic disorder.
Sleep apnea is not a small population, and is does not fall under the usual definitions of 'life-threatening'...even though it is deleterious to health; and there is effective treatment available, even if highly flawed and problematic (CPAP). I see no way that the FDA would even accept the filing of an NDA based on this Phase II.
Prospects for Cortex? They depend upon whether Arnold Lippa is able to obtain enough funding to run the trials he needs to run--or at least, to stay functional until the dronabinol trial finishes and hopefully shows positive results....
NP
Zero.
NP
Gfp:
Re: Anavex. I've known Christopher Missling for--must be about fifteen years now. I'm curious about sigma-1 as a target, it has had something of a resurgence of interest after being forgotten/neglected for a while (not unlike AMPA receptors). But, Anavex being cash-strapped, they are relying upon biomarkers which are not viewed as meaningful by the AD community, and small-scale open-label studies do nothing more than assess safety and patient suggestibility. It's too bad he doesnt have the money to pay for a reasonably scaled Phase II, it would be interesting to see what the drug could do.
NeuroPerspective
GFp:
This Wikipedia entry is seven years out of date. Most of these programs no longer exist.
Bladerunner:
I've been following ganaxolone since 1995 (CoCensys), and Marinus' refined formulation for six years at least. It's an synthetic form of allpregnenalone; so is SAGE's 547, a slightly different form that is IV delivered. SAGE has achieved massive momentum through addressing Status Epilepticus, but there's no reason to think that Marinus' oral ganaxolone would not also be effective with seizure disorders.
OK. I'm not going to be looking in here very often, and will be commenting even less....
NeuroPerspective
OT (TRGT) Any company with $90 million in cash has the 'potential for recovery.' But having resisted suggestions to diversify beyond nicotinics for the past four or five years, they are now having to figure out how to proceed in a post-nicotinic environment (for them, and for most, albeit not all, of their competitors). They don't yet know where to go in terms of inlicensing/M&A, but they know they cannot afford another misstep, $90 million doesn't go as far as it used to. I wouldnt bet on it being spent on a CNS program(s), though they tell me that is still a possibility.
NeuroPerspective
No, I organize an entirely different meeting, and speak at a few others, but I'm just an attendee at this one. Biotech Showcase is a good venue, sharing time with the neighboring behemoth JP Morgan conference. Good choice for corporate promotion.
NeuroPerspective
Looks like a very reasonable, pragmatic approach. The question is: Can Cortex now raise the money necessary for the next set of clinical studies? The good news is that the climate for CNS funding is hugely different than it was even a year ago at this time. To illustrate:
The level of VC/institutional/secondary offering proceeds raised by small CNS companies was devastated from 2007-13.
2006: (millions) 1922
2007: 978.7
2008: 839
2009: 826
2010: 917
2011: 604
2012: 954
2013: 957
2014, YTD: 2669.
YTD the total financing raised is almost triple what it was last year. There is a dramatic increase in funding, and most of it is not due to the ten IPOs in the CNS sector thus far in 2014, but those IPOs give VCs the reassurance that there will be an exit available. CNS has regained credibility, which gives Lippa a much better chance of attracting the funding he needs.
NeuroPerspective
Since I am not aware of any plan to develop a unique formulation or dosage form that would make it possible to differentiate and thus premium-price their version, the cost of the generic sets a ceiling on their pricing of a branded form for sleep apnea. How they will budget for marketing of the 'first drug for sleep apnea' out of that constrained revenue stream is an interesting question. On the other hand, the drug does not have to make a lot of money to be worthwhile to Cortex--it's a low fiscal bar to surpass.
NeuroPerspective
Gfp:
It's good to hear from you, glad to see that you are still around.
The new management has achieved two essential goals:
1) Cleaned up the fiscal debris from the near-bankruptcy
2) Re-established the IP relationship with U. Illinois
The two questions I have at the moment (you raise some interesting points about the breadth of the UI cannabinoid patent) are:
1) Are they planning to wait out the Phase II now ongoing before doing anything else with the cannabinoid angle? If so--they've got a year or so before that trial is projected to be completed.
2) What is their agenda for the Ampakine compounds still in their control? (the use patents are gone, but they are ancient anyways)
The answers to those questions will determine what their need for additional capital nearterm is...
NeuroPerspective
OT: Prana
The MF story has the dates wrong. The Huntington's trial results (109 patients) are due in October, the AD trial--only 40 patients, so a minimal size n--by the end of March. Prana recently accepted my invitation to participate in a conference whose neuro component I organize, and I wouldn't have invited them if I didn't think they have a shot at making it work. The previous Phase II was pretty skimpy, and they had to dig to find some evidence of positive effect, but Tanzi/Bush are very respected people in the field, the theory does have some interface with both amyloid and tau,,so it's not completely tangential to the main ideologies.
The two trials together--since it is the same drug, and the premise is that it addresses the same metal-binding pathology downstream in both disorders--are probably the most important datapoints for AD that we will see in the next 12+ months.
This does not represent a prediction they will succeed, but they have a chance.
NP
I believe that IP which required maintenance payments has gone back to the original holders--UC and UI--but there is nothing thus far that would strip Cortex of its control of Comp-of-Matter for its compounds developed inhouse. And the use patents controlled by UC are approaching their end of life, and so they are irrelevant--nothing developed now could arrive while those patents are still in force.
Similarly, unless the Greer/U. Alberta rights required scheduled payments that werent made (I have no idea and I'm not planning to look), that agreement would also still be intact.
OT: Someone recently sent me a PM, the first in two years. I discovered that I no longer have PM reply privileges in the eyes of InvestorsHub, and I have no intention of paying for them. So--my email address is findable,and I'd be happy to reply. But not via PM.
NP
OT: Galleon and RD
No one regulates press releases, and Galleon likely thought it not helpful to say 'this is the second time--and the people who did it first couldn't raise money either."
Galleon has been around since 2005, hoping to develop s-nitrosylating agents for RD and sleep apnea.
Galleon said this in 2006:
<<Galleon received $500,000 from
BioAdvance in 2005. Galleon is raising
a $5 million Series A round primarily
to support two (2) Phase IIa proof-of-concept
clinical trials scheduled to begin
in 2007.>>
In 2008, they had claimed to have shown 'POC' in trial, but gave no details. Five years later, they have finished a 12 pt trial, and are still hoping to raise money to do an actual Phase II.
NP
Athero:
You're addressing someone who has been talking to himself and thinks that the fantasies he constructed constitute reality. People like that have no interest in outside information, they just twist it to conform to their own belief system. There's nothing to be gained from engaging them. I no longer bother trying.
NP
I've been following the Z160 story since it started at Neuromed--ten years ago perhaps? It is still one of the most promising nonopioid painkiller candidates--but I doubt anything will completely supplant opioids, so a safer opioid version would still have utility, no matter how well the Zalicus N-type calcium channel blockers perform.
NP
Just to note--the new management isn't that worried about the dronabinol license either--<<Regardless of whether such new license agreement is reached, due to its rights of inventorship and independent of the License Agreement, the Company remains free to practice additional patents and patent applications describing a dosage range for the use of dronabinol in the treatment of sleep apnea, as well as for various formulations of dronabinol>>.
But while the lack of interest in the UC license could mean a similar belief that they can work around IP that has a declining shelf life, it more likely means that they are focused on dronabinol and SA, not RD/Ampakines. Which, as we both would agree, is a shame.
How the three pools of RD/Ampakine IP and assets/compounds: UC, Cortex, Greer, now function as potential venues for continuing this work, I have no idea. If Cortex isn't going to use their compounds, they'd probably be happy to sell/license them. UC's license is no good to them unless a company licenses it, and as I said before, if someone was interested, Varney would probably have found them. I very much doubt that John Greer has access to anywhere near the level of funding necessary to continue Ampakine development, even if he could get access to compounds and regain all necessary IP.
The people with money have no interest, and the people with interest have no money. I keep thinking some midsize pain company is going to wake up and decide it's worth putting $20 million into this indication in the hope of developing a genuinely safer--as opposed to less-abusable--opioid painkiller.
But I've been thinking that for years, and I've tried to convince a few companies that this should be pursued, without success. I don't know what is going to change that.
NP
I agree with you on the clinical need--it's frustrating that, when the pharma industry, and media, frame opioid 'safety', it's usually in the context of preventing abuse.
In the pharma industry, no one considers a small Phase IIa as providing 'proof of concept.' The only people who try to do so work for tiny biotechs who try to frame their limited data as such. It's not that anything was done wrong, you just can't (if you want to be taken seriously) overstate the certainty afforded by a single small Phase IIa. We have seen too many small trials that failed to replicate when expanded. That's why I suggested HOC--there's something that hints at therapeutic effect, but it has yet to be 'proven.'
NP
<If I were running the outfit, I would approach VCs with the simple pitch to secure funds to bring ampakines into the clinic for the most easily accessible indication, probably post operative RD. If/when it gains approval for that indication, move towards a partnership that incorporates ampakines in one of the many pain management formulations that are being used by millions. That's a big payday, and it's not that hard. Efficacy is established, and the market is huge.>
Enemem:
You don't think this was tried? For the most part, VCs are not interested in this kind of opportunity. Why? They want to know whether the exits are, and how much it would cost to get there. We think efficacy has been proven, but it hasn't, not by their standards. Cortex has what I call HOC--Hint of Concept. The quickest exit used to be post-Phase IIa data, now it is post-PhIIb. To get there you'd need to run a couple (in different populations, including elderly) larger PhII trials. Even run as a near-virtual operation, this would take a couple of years, costing at least $20 million. In 2012, there were just four VC/private investor CNS fundings that were $20 million or above: TauRx, which tapped its Singapore investors again for a Phase III in Alzheimer's; Naurex, which raised $38 million to run PhIIb and beyond with its rapid-acting antidepressant (the biggest story of 2012); Collegium, doing reformulations; Marinus, running PhII trials in multiple disorders with ganaxolone, which has considerable PhII data already. Of this group, only Marinus is a relevant comp, so it's not like this is easily and frequently done.
To get through your benchmark of PhIII and 'approval', figure another $40-50 million at minimum. Particularly with the legacy of Lilly's failure in this area, VCs are not going to be easily convinced that new investors will be available after PhIIb for an Ampakine in an indication that has no established regulatory path to approval.
Which is why I hoped a Pharma--one with a pain program agenda--would step in. VCs are very unlikely. Varney tapped whatever VC connections he had, and couldnt get anything. The unknown variable is whether Lippa et al have other VC/investor connections who might be convinced to do that $20 million first tranche.
As to the ex-UC license strategy: Gfp used to have notes regarding patent expirations:perhaps the new group sees some critical IP as reaching the end of its shelf-life, allowing them to operate without a license. It's not like anyone else is going to bother.
<<That's a big payday, and it's not that hard>>
People with money are not at all sure of the former, and certainly don't believe the latter.
NP
It must be very disappointing that you have nothing to contribute here but venom.
NP
I did not ask him specifically about Ampakines, which would have been tantamount to asking about Cortex, since no other company had a regulatory 'problem' vis-a-vis Ampakines. And I had provided numerous other questions that I either asked in person or were asked in a group setting by a moderator: that particular topic felt like it would cross a boundary.
OT (ACAD): To me the schizophrenia angle is dose-sparing in order to reduce side effects, especially weight-gain. I think this will get off-label use, albeit more likely on an outpatient basis, since inpatient units have formulary inclusion issues and often simply receive a daily preset amount of reimbursement from insurors, and they don't want to add the cost of a new branded drug. But if a psychiatrist has outpatients who respond best to Zyprexa, but blow up weight-wise, adding pimavanserin to see if the weight-gain can be ameliorated is something that some will try. And if they try it and are successful, this could spread.
There have not been any noteworthy additions to the sz tx options other than reformulations. The programs seeking to add nicotinic alpha7 or glycinergic drugs for the sake of impacting cognitive/negative symptoms are the 'next big thing', and the most advanced are in Phase III.
NP
OT(ACAD):
Blade
1) Yes, I was very pleasantly surprised. I don't know whether this is a new trend or just an exception--I hope for the former. Laughren retired this past December. I had the opportunity to talk with him at length a couple weeks ago at a meeting: Very decent and knowledgeable guy. no agenda other than doing the right thing, but rather conservative and narrow in his view of how to get there. It wouldnt take much to be more flexible.
2) I have a good friend whose firm owns a lot of ACAD--He would say it is not yet fully valued, based on the current market cap against likely peak sales of pimavanserin for PD, AD, sz.
3) Back in December I met with a pharma regarding licensing opportunities. Acadia had just released its data and the price had risen, but I told them that it pimavanserin should be a priority target for a partnership. They complained that the price had just gone up. Well, it just got a lot more expensive. And Uli Hacksell is hardly an impulsive CEO, he doesnt have to move quickly. Given that most large pharmas continue to lowball their CNS partnering offers, I'm not expecting imminent news. But then again, someone could decide to wrap this up next week, making Acadia an offer they can't refuse. It would surprise me though.
Congratulations on holding ACAD longterm.
NP
I think you make a good point about the cost of clinical advancement. If someone wanted to buy one or both chunks of Cortex's assets, they could have done so with Varney. My suspicion, and it's only that, since Lippa has not responded to my inquiry, is that the price of raising money to go ahead with a clinical trial for an Ampakine is a change of control--as I've commented before, financings seem to operate in circuits of familiarity. Varney's sources had dried up, Lippa probably has his own circle of financing resources. But I suspect current shareholders will not be happy with whatever terms eventuate (though bankruptcy would be even more unappealing). Alternatively, if dronabinol for SA is the asset of choice, that trial is paid for, they'd need to raise enough money to keep the lights on, since the NIH grant can only be used for trial costs, not overhead.
Two weeks ago I was at a CNS drug development meeting where someone from NIH polled a few of us to shelved mechanisms that deserve another chance (NIH has some money they are putting into this concept). As I usually do, I mentioned Ampakines, and a few Big Pharma people nodded their heads. But none of them have painkiller-induced RD anywhere on their radar, and the diaspora of ex-Lilly people around the industry means that several companies have scientists who say--'we couldnt solve Ampakines, so they're not solvable'. RD is not an indication NIH is considering.
If someone can run a Phase II that gives convincing 'proof of principle' (an illusory term, the way it's used at present), they'll find a buyer, I believe. Probably a pain company. Why a pain company hasnt stepped up thus far is something we have all wondered about, it's a discredit to the industry.
Cortex's market cap must be in the $5 million range, and they'd probably need $10 million to put themselves in position. Lippa may have an idea--and resources--to get there, but it would be ugly. If instead, keeping in operation for the sake of dronabinol is the goal, and Pier's participation in the takeover leaves that open as a possibility, that would be a lot cheaper, but that would leave Ampakines on the shelf, perhaps forever.
NP
Agreed, Samyang would have the one BOD seat not 'unseated'. As to Lippa et al's intentions--I havent spoken to Arnold Lippa in at least ten years, but I believe he's in his mid-sixties. I actually walked by him at a meeting a couple months ago, and filed away the fact that he was still around. Never dreamed he'd surface in this context. He could conceivably want to take charge of another biotech, but I don't know that to be the case. We'll find out soon enough, I suspect.
NP
Two other notes:
1) It will be interesting to see which of the current directors is retained.
2) Arnold Lippa was a founder and CEO of Dov Pharmaceuticals. They were a highflier for a while on the basis of their indiplon partnership with Neurocrine Biosciences, subsequently licensed to Pfizer. When indiplon ran into FDA problems, Pfizer departed, Neurocrine languished until reviving itself outside of CNS, and Dov was liquidated, its remaining assets picked up for a pittance by Euthymics Bioscience, with funding from Novartis Bioventure. They are in Phase IIb for depression, and spun out Neurovance, in Phase IIa for ADHD.
NP
One other issue: Some pharma companies, even some of the largest, now have a policy where they cap the number of CNS programs that can be in clinical development at any given time. If a new one is inlicensed, they have to terminate something already inhouse--which means something that they developed themselves, hence there is an internal champion for the program, or one that was previously inlicensed-also championed. We like to think of it as--it would be cheap to acquire the rights to Cortex's compounds. Pharma companies instead calculate how long and how much they would have to spend to take them all the way through clinical testing and regulatory filing--and for many, what program(s) they would have to sacrifice in order to do so.
This makes the decision-making more complex, and to be frank, colored by emotional factors. Companies now like to say they no longer espouse the 'not invented here' bias, but it still plays a role.
NP
OT: I know that their Phase III lung cancer trial with Merck KGa failed--but other than that, it's not my area. I'm sure that you know more than I do about ONTY.
NP
Since my post didn't relate to anything specific to Cortex, it doesn't establish anything one way or the other. The fact is that I am on the outside looking in as well--but anyone who doubts that Mark Varney is talking to anyone and everyone who will listen is missing more than a little common sense.
My posting is not correlated with a presence or absence of negotiations by Cortex.
NP
The question is whether this will start to also be seen in the CNS area. As BioCentury noted in its most recent issue: <<Most of the expedited approval mechanisms require circumstances that currently are rarely found in neurology: thoroughly validated biomarkers, well-defined subpopulations at high risk of death, and few therapeutic options. Over the last decade, only 18% of CNS drugs received Priority approvals, compared to 46% of other drugs, according to
the Tufts Center for the Study of Drug Development.
Tufts also found that from 1996 through 2010, the “mean clinical phase time for CNS drugs, compared to non-CNS drugs, was 40% longer, while mean approval phase time was 13% longer.>>
Both the directors of the FDA's Psychiatry and Neurology divisions have (Laughren) or soon will (Katz) resign. The big unknown is who will replace them, and how much risk will they be willing to tolerate in accelerating drug approvals.
NP
I'm not totally convinced that there is an imminent wave of legalization and medicalization about to swamp the country. I know Washington and Colorado went to legalization, but California, the heartland of the medical marijuana movement, voted against legalization when it most recently was on the ballot. And in Southern California, most dispensaries have been shut down--there was a recent news report that not a single dispensary remains open in San Diego. It's cyclical, and it probably will end up with relatively open access, but the question of dispensary-provided THC as a competitor to dronabinol is among the least of Cortex's problems. If they are still around to worry about it, something else will have to go right.
As I have written before, the place something could (and should, but that doesn't mean much these days) go right, sooner rather than later, is in circumventing the effects of Respiratory Depression. Galleon's work that you cited--nice find on that PR--employs a s-nitrosylating mechanism associated with cardiovascular side effects. I don't know where they did this most recent trial, it wasn't in the US, and they are not going to find funding easily either.
NP
Three thoughts:
1) There is considerable variability in the dosing of THC and other psychoactive components of marijuana in natural preparations, be they smoked, swallowed, or whatever. I don't expect prescribers to embrace these wholeheartedly (even in California, it is a very small slice of the physician base that participates in providing patients with cards denoting them as eligible for 'medical marijuana), because of liability issues. If you don't know what the potency of a drug is, selecting a dose for a prescription is a guessing-game.
2) Similarly, patients who want their medications paid for by Medicare or private insurors are unlikely to see medical marijuana in any form reimbursed in the foreseeable future. For largely the same reasons as cited above for #1.
3) There are a lot of patients who--unless the pricing for a pharma option is prohibitive and not reimbursible--are not going to go through the trial and error of figuring out self-administered marijuana for something like SA.
You can knock yourself out with a GABAergic drug like alcohol, in the form of tequila shots. That doesn't mean there hasn't been an enormous market for GABAergic insomnia drugs.
NP
(Somewhat OT: TRGT) Targacept projects having $180 million in cash at year-end. They could afford multiple licensings. I've suggested a Cortex licensing to them in the past, though the overlap in relevant indications has always been a problem-- and have for a couple years suggested they diversify their portfolio beyond nicotinics. But that is the big question for TRGT--under their founding CEO, who had spent his entire professional life in the nicotinic area, they never moved outside of it. The question is how aggressively the new CEO will do so.
NP
<<More than for any of us, corx's failure defines Coleman's life>>
Enemem, I know that your intentions were entirely humane with this, but in a way, it illustrates the Cortex-centric thinking that can be misleading.
Jim Coleman worked for Cortex from age 59 to 71. I don't think he would agree that Cortex defines his life. Thirty years at Pharmacia and Upjohn, a family, served in the Marine Corps....His reputation in the industry is, so far as I have ever heard from anyone, positive. As is the case for most people on this BB, his investment agenda with Cortex failed (my losses approach Davey's), but while painful, that doesn't define who he is.
Similarly, just as your comment suggests that the arc of Coleman's life achievements is largely constructed around the outcome for Cortex Pharmaceuticals, Cortex-centric thinking holds that, to some degree, the pharma world revolves around Cortex; that the Cortex portfolio was congruent with what the industry wanted and would invest in; and that the fact that it did not come to fruition reflects a failure to execute on the part of Cortex management.
That is a fairy tale. Some people embrace the fairy tale in spite of the lack of any supporting evidence--a process that Stephen Colbert defines in his parody of 'truthiness'--'truth is what you feel in your gut'. It is a rationalization that is convenient for scapegoating, a short cut to explaining a complicated situation in oversimplistic terms--a way to justify the visceral wish to 'make someone pay.' But that's all that it is.
NP
The single persistent hope for Cortex at this point is the fact that--once again--a lot of public attention, and the FDA's, is being focused on the issue of opioid painkiller risks, both in terms of overdose and abuse.I don't know of any other technologies that are in development for, let alone with hint-of-concept in, preventing opioid-induced Respiratory Depression. Thus as I have said several times before, it is utterly baffling that no company or (less likely, but possible) investor has seen enough potential here to buy into the RD program. That is primarily a reflection on the pharma industry and its associated investors at present, overgeneralizing from a long history of frustration and failure in AMPA modulation, most of which occurred at companies other than Cortex.
The FDA is having a public hearing in February on the opioid analgesia issue overall. Just to give an example of the way the FDA and its Advisory Committees sometime think (not necessarily in unison), the Zogenix opioid Zohydro recently had its AC vote 11-2 against approval. The reason wasn't Zohydro per se--that being the first hydrocodone painkiller not accompanied by acetaminophen, which raises possible liver toxicity issues in itself--it's as effective as those already on the market, and no more prone to abuse--but the AC is unhappy with the failure of current regulations to circumscribe opioid abuse. Zogenix just happened to be on the docket when they decided to make a statement, and hence was the scapegoat.
Gfp follows Cortex finances closer than anyone I know outside the company, but I suspect that Cortex is no longer able to pay salaries, whoever is there is working pro bono at the moment, and Maria Messinger's departure is probably a reflection of that fiscal reality.
So, RD is Cortex's main ticket to survival, and I havent the faintest idea whether anyone is going to respond to the obvious and take a shot.The fact that longterm use of AMPA-modulators is currently seen as risky by everyone but Servier is a deterrent, though one could argue that in a terminal cancer population dependent on opioids for even a minimal quality of life, time-limited as it is, ambiguity around longterm safety should not be the barrier to entry.
NP
Haysaw:
You do provide a useful service. Ten days ago, I moderated a panel in Boston that I'd assembled, that included the neuroscience heads of Merck, AstraZeneca, and Lilly. I found that rather intimidating, trying to guide a discussion with people who possess that kind of expertise. Then I spent five days at the American College of Neuropsychopharmacology meeting, where I was surrounded by luminaries whose command of the area is so far beyond mine that I sometimes felt like a high school student. Very intimidating and humbling. But then I touched base with this Board again, where I can always count on you to deliver the kind of depth and insight that, by comparison, makes me feel like a Nobel Prize winner. Thank you.
NP
Well--so far as I know, the Pier merger was finalized. So unless there was some legal underpinning to undoing it, and that we would have heard about--I don't see how it could not be intact. But everything you raise is a valid question. I'm frustrated at not knowing what's happening as well, but my attitude is: I don't expect an EMT doing CPR to give me a play-by-play, even if I'm a family member.
NP
It is still possible: I continue to be baffled that no one, in view of all the headlines about opioid-induced deaths (via RD), and all the money that could be made from a 'safer painkiller', has made a modest bet here. It is the most frustrating thing about the pharma industry, that the amount of genuinely innovative thinking (from a business, rather than scientific view) is so minimal.
That lawsuit looked to me like someone who is a serial litigator--but since I don't know the details....
NP
From a pharma industry point of view, he played the molecular cards he had. And the cards weren't as good as I, and many others, thought they were. Did he oversell the hand? Well, if one is trying to get a partner or investors to buy in, you sell the most positive view you ethically can. I'm not aware, in retrospect, of any overt dishonesty on the part of Cortex management. Spin, yes, that's part of their job.
It's the biggest loss of my investing career, by far. But in my view, that's on me. I'm not looking for a scapegoat. There's no strategic alternative path that clearly would have been better, with all due respect to Alzheimer's.
P.S. There was a November 8 timeline mentioned, but I didnt read it carefully--you're probably right that it was contingent upon exercise.
NP
The argument against that would be that Pier Pharmaceuticals was built around Carley's work, so I presume that he had some contractual agreement with them in terms of rights to that program. Thus, even though the money goes with the PI, in this case, the PI would have some responsibility to the acquirer of Pier, Cortex. The fact that he left the BOD does not necessarily mean that he walked away with the program and the grant--though it is baffling.
However, it is curious that in the original merger agreement, Cortex was to issue a S-1 regarding the contingent shares assignable to Pier before November 8. I see no evidence of such a filing, though I havent looked particularly hard.
Frankly, ever since the BOD resignations, I've assumed that the end game was upon us, and each day, half-expected to see some type of final announcement. Hasn't happened, and I haven't tried to contact the company until today; no response yet.
FWIW: Last week I was asked to go to a substantial midsize company to present a half-day workshop on licensing opportunities. I saw them as a reasonable candidate for RD, and presented the Cortex RD program amongst twenty-five or so recommendations. They expressed some vague interest in that indication, but not enough to make me think anything will come of it. What is pertinent here is this: They expressed trepidation about the whole AMPA-modulation area due to the safety issues encountered by so many companies. This Board tends to think of Ampakines in a Cortex-centric way, I do as well---but in the industry, the years Lilly put into AMPA before finally giving up, as well as the briefer forays by Pfizer, GSK, Merck/Organon, color the story much more completely. Basically--their view is: if Lilly couldnt figure it out, why would anyone think they can? Servier doesn't particularly enter into the conversation, they're an odd-duck in the pharma world.
The other interesting thing was this: One of the scientists there knew Varney from the past, and seemed to have followed the story from afar. He commented: "Mark Varney did a great job trying to advance that compound."
When this board is being barraged by its own versions of Donald Trump howling ad nauseum about birth certificates, keep in mind that their information-base is limited to their own imaginations.
NP