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Aiming:
I want to apologize for having inferred that you had chosen to not ban anyone from the thread (due to a desire to be as fair as possible, which is in fact true of you). On SI, moderators have (or had) the power to do so, and it is unfortunate that here, you have the responsibility of overseeing the board, but not the power to take drastic action. That makes your devotion to an unpaid role doubly commendable--and stressful. You should be receiving thanks, not criticism.
NeuroInvestment
I appreciate the several emails that have been sent my way. As I mentioned in one exchange, looking in on the thread this morning was like flying over the island of 'Lord of the Flies', seeing the schoolboys circling the fire while howling in a bloodthirsty frenzy.
Frankly, not a place where one would want to spend much if any time. But I'll note something that seems to be overlooked:
A fund (almost certainly a fund, not a pharma; I think I know which one, and they're very sharp) has $1.5 million less in cash than they did before this transaction. They clearly think that giving Varney more time to complete a partnership will pay off. These are not people who toss their cash around randomly.
NeuroInvestment
Been here, done that. I have enjoyed many of the discussions on this Board, but this is well past the point of diminishing returns. We all have to make our choices, and I choose to no longer waste my time and energy dealing with the pond scum. Since they apparently are staying, I am done here. Best of luck with everything.
NeuroInvestment
Enough of this garbage. Posting sneering, snarky comments behind the shield of anonymity requires the same level of character as is displayed by Somali punks pointing guns at unarmed sailors. Zero. You've had more than your share of chances to show that you are not just a two-bit liar (we know from your posts you own nothing) who baits and smears for reasons of no interest to me. But you've squandered them.
So it's time to clean up this Board, Aiming. To make it very clear, I am not referring to eliminating criticism of Cortex. I may disagree with some of the things that people like 'Haysaw', 'RBlatch', and 'Food4thought' say; I may consider some of those statements unfair or underinformed. But I also think they reflect a sincere, genuine point-of-view, and are therefore worthy of inclusion and discussion. But 'Iggs' and 'NakedMouse'(assuming they are not one and the same), dishonor themselves and taint a Board which most participants turn to for information and honest opinion, not juvenile trashtalking.
It's time for them to go. I am not participating here for the sake of experiencing a slightly less putrid version of the Yahoo MB. Sorry it falls on your shoulders, Aiming, but you are the moderator. Iggs and NM deserve to be expelled. If they aren't, I've got plenty of other things to spend my time on.
NeuroInvestment
When they did the Organon transaction, they had less left in the till than they do now.
The Greer IP is not the kind of licensing anyone was referring to or complaining about--and was not what they meant either, at the time. Spending next to nothing to expand Ampakine usage is not an issue--acquiring a non-Ampakine technology to develop in the clinic, that was the subject of dispute. Fortunately (at least in my opinion), they were able to change course.
NeuroInvestment
I don't envy you trying to maintain a sense of fairness when some of the participants on this thread feel free to slander from behind an internet alias, and then throw a tantrum when called on it. Just to note, my removed post did not cite any posters by name, or even species. Let alone make reference to criminal intent. The fact that some saw themselves depicted in the metaphor--that speaks for itself.
This post likely has a short half-life as well.
NeuroInvestment
<<Ampakines are broad-spectrum>>
That's not what Gary Lynch believes. There are subtypes of AMPA receptors, and different Ampakines have different profiles of activity--including varying degrees of waking/alerting impact. I agree that the insomnia question is a big one--but as I noted before, they've run Phase I studies where insomnia would have been an AE of interest.
NeuroInvestment
The possibility of a private equity buyout is not something I have any buzz about, and would find very surprising. The other three are all possibilities.
Regarding stock options, 3,4 would appear to offer that possibility.
NeuroInvestment
There are some--probably one for every ten that are in trouble. And there are literally dozens of small advisor/banker outfits trying to arrange marriages.I've had several ideas, I've had numerous conversations on such issues. Three factors make this challenging, albeit still possible:
1) That 10:1 ratio means cash-rich (and rich can be defined pretty loosely here) companies have lots of offers to consider, it's their market to control.
2) Except that there has been a trend towards minority shareholders hijacking these companies in order to liquidate them and take out cash. BVF bought into Avigen at .58-.60 last fall, and with a well orchestrated campaign, was able to dump management and will be liquidating at 1.20 or better. NTI, Vanda have similar fund uprisings going on, where the minority shareholders fear that M&A will go awry. Which it can--Epix, which you mentioned, now has a market cap of just over $20 million. Considering that two years ago they had $109 million in cash... that's pretty grim.
3) Small neuro companies are so self-preoccupied they often are not really up to date with what is going on with their peers. One of the seemingly possible M&A candidates literally said something along the line of 'Cortex...that's that company with the drug the FDA put on hold...' And anticipating the next question, does that mean Cortex has failed to articulate their case, the answer is no. It reflects the fact that small companies are so used to positively spinning their own stories that they figure new information from a competitor is just spin of the same type. This doesn't apply to all, but it is a factor.
M&A remains on the list of possible outcomes.
NeuroInvestment
The BOD gets to decide, as the elected representatives of the shareholders, what is a credible offer. They don't have to get a shareholder referendum. As I said, with a SA trial ongoing, I don't think they'd consider that credible, nor would I.
If you have watched proceedings at Avigen of late, there can be disagreement about what a credible resolution is, and a shareholder with a significant minority interest can challenge the BOD and call a special meeting hoping to unseat the BOD, or at least use a vote to force a different decision. That's how it ended at Avigen. The BOD was forced to move to liquidate the company.
NeuroInvestment
Why would the BOD go for .50-.60 per share when there is a SA trial going on? If it fails, maybe so, but not now, not when they are within weeks of knowing, one way or the other.
NeuroInvestment
Well, Lilly's compound made it through Phase I also. Sometimes you don't catch these infrequent side effects until you are in larger-scale trials with patient populations. So we cannot totally assume CX-1739 will never encounter any problems (CX-717 is a good example of this).
NeuroInvestment
There's another Lilly angle that could have relevance now or (more likely) later to Cortex. Their mGluR2/3 modulator LY2140023 came up empty (as did olanzapine/Zyprexa, due to a high placebo response) in a schizophrenia trial. Now this mGluR2/3 strategy had become Lilly's cognition emphasis in recent years, supplanting AMPA-modulators, which had seizure problems, as we have discussed. Now the interesting thing in this trial failure was the fact that three of the drug patients had seizures, yielding an incidence rate of what I estimated to be around 1.5%. Hence NI's April sidebar headline: 'Seizure Risk Dooms Lilly Drug.'
They claim that they are going to continue the program, but this compound would be DOA with the FDA. And I have some information indicating that this may be a class effect with this group of Lilly compounds. Thus one also has to wonder about Merck's mGluR2/3 program, which is run by Lilly's former head of neuroscience (now Merck's).
Lilly may be in a state of semi-denial, so this probably does not translate into anything near-term. But given their insistence a couple of years ago that they didn't need to join with Cortex, because they could beat them, one of their main weapons may have just been dismantled. Schering-Plough, GSK, and Cortex may have just had the value of their Ampakine programs enhanced by process of elimination.
NeuroInvestment
Dew:
Neither of these Lilly sources would go into that. Actually, I don't think the first one yet knew, they hadn't figured it out (two years ago). The second one did, but wouldn't say.
NeuroInvestment
Adderall XR went generic (Barr) yesterday. Shire has been working overtime trying to switch patients to Vyvanse, but I am skeptical that payors will absorb the premium for a drug that offers modestly longer duration and what some patients report as a 'smoother' subjective experience. As I noted yesterday, Concerta could go generic sooner than expected. Those are the two 800lb ADHD gorillas. In terms of off-label less-than-impressive choices; Provigil goes generic in 2011, Nuvigil is ready in the wings, and offers very little advantage other than modestly improved duration of action. For Shire and JNJ, this will be generic hell.
Strattera is mediocre. Another source from Lilly recently confirmed (again) that Lilly knows it only is effective in 20% of patients, and that they know which subgroup it is--and if they were launching today, it would not be for the whole population, they'd try to target that subgroup. Too late.
One would think that this would accelerate the development of nonstim ADHD alternatives, the nicotinics and Ampakines to name two.
NeuroInvestment
I'm not saying $5 is outlandish or that SA isn't huge--but in the environment as it exists today, in a buyer's market unlike anything I have ever seen, a 20pt Phase IIa will carry modest weight: enough for a deal, but probably not for the kind of huge upfront payments that would galvanize the stock price in the way that you suggest. I'd be happy to be wrong about that. Might it bring it to a level from which a major ADHD deal could then get you there? That seems more realistic as a best-case scenario.
It is worth noting that JNJ's patent control over Concerta is in jeopardy, one key patent was overturned today. If the second one is also overturned, that $1.2 billion Concerta franchise is going to be kneecapped. Which might bring JNJ into the ranks of those interested in a new ADHD approach.
NeuroInvestment
Yes, eventually--but there is a long road from awaiting pilot trial data in SA to that statin size market. I don't personally see an early-stage SA deal turning into a $5 share price in this environment.
NeuroInvestment
Blade:
I could not have said it better. That pretty much sums it up--though if they were to do a financing here, it would be for small money, extending their 'runway' for a couple of months, getting SA done and (if positive) partnered. I do not expect a reverse split, there's really no point, since AMEX appears to be very lenient about listing requirements.
NeuroInvestment
It seems to me that acquirers usually cull unwanted employees once they have made the acquisition, so while I am not certain, I doubt that this is the case here.
NeuroInvestment
I believe the SA trial is planned to enroll 20 patients, though they didn't know how many would have to go through the first two screening nights in order to get 20 who meet criteria.
As to the questions raised by DavidAl etc about whether some event, dire or otherwise, is imminent--if there was an imminent event, they wouldn't have downsized.
NeuroInvestment
Your recall may well be better than mine, but I thought Varney was referring to an ADHD trial when discussing the Q2-Q4 timeframe.I don't think Cortex wants to be the company running a multiple dose sleep trial, they want that partnered. Of course, there is no money for any multi-dose trial in either disorder. They have enough to finish the single dose SA trial, that's it.
The sleep apnea trial, as I understand it, is a single dose trial, following two sleep sessions where the baseline apnea frequency, including the all-important consistency of scores across nights, is established. DavidAl undoubtedly has a better sense of exactly how the apnea episodes are measured and defined, but this is a pretty standard process. The added element is the need to carefully establish that each patient has sleep apnea, and that it affects them with the severity each night. Otherwise, you won't know if a change was due to variability in the baseline rate, or due to drug.
I don't know if they are including CPAP patients, since that would raise some ethical issues of withdrawing effective therapy. There is no shortage of SA patients who are not on CPAP because they hate it.
NeuroInvestment
Gfp: I agree with this--there's got to be a thread where those who are interested in this line of discussion can do so. Your long-standing and vital contributions to on-topic discourse have earned you a lot of slack, but enough is enough.
NeuroInvestment
With SGP and Merck trying to consummate, SGP isn't talking to anybody. This past week, I did meet a clinical trial expert who had helped run the Org26576 depression trial, and was quite proud of the bells and whistles that had been included. But if he knew how the results had looked (and I suspect SGP took the locked dataset, said 'thanks', and went inhouse for the unblinding), he didn't let on.
I'm not counting on anything--partly because I'm not sure what to expect of Org26576 as a molecule, partly because SGP is so preoccupied they may not say anything in time for it to have any effect on Cortex's partnering discussions.
Enemem: It is a different environment out there. And as I discussed at length about three months ago, some BP's are quite explicit that they are willing to wait for small companies to starve so they can get what's left as cheaply as possible, others say that they don't believe in doing that, that they are better off with a small company partner that is intact enough to provide expertise.The lack of partnering activity overall can also be attributed to what essentially was nearly an industry-wide freeze on spending for several months. For example, Pfizer cancelled/suspended many clinical trials, I had consulting work suddenly withdrawn by another Big Pharma, etc etc. There does appear to be a thaw now, for the past few weeks. Pharma companies are starting to spend again on clinical development activities, we'll see how rapidly money comes back to partnering/BusDev.
NeuroInvestment
Gfp, of the three summary posts you provided, I think the first two together constitute a very solid appraisal of the current situation. At least on first look, I have little or nothing to add. I don't agree entirely with the third segment.
Not that SA isn't critical, indeed it may be that RD has become melded with it in the eyes of some if not all prospective partners, which raises some of the complications you noted. But if SA fails, Plan C IMHO would be to try to partner CX1739/ADHD for ex-US use. The terms would not be great, but they could probably get enough to run that pilot trial in ADHD. If that was successful, then they would have the US rights to partner on better terms--perhaps the EU partner would have a right of first refusal with preset better upfronts.
Blade: Regarding virtual company resurrections; I know lots of private companies that are existing in near-virtual mode. But but I take it that your question pertains to companies which have shrunken back into virtual mode and, to some degree, hibernated while events unfolded out of their hands. The closest example I can think of might be Cypress Biosciences, which went through some early problems/failures, before I followed them--then licensed milnacipran, which they then licensed to Forest. While Forest did the Phase III trials for milnacipran in fibromyalgia, Cypress was down to around 12 staff, looking at licensing, kicking the tires on a few possibilities, but really just waiting for Forest's trials to be completed. There are plenty of differences in terms of cash on hand (they had to use some of their upfront money to help pay trial expenses), level of program development, but I can't think of anything more relevant--and this isn't very relevant. I'm not sure the virtual model (I don't know exactly how Garren defines it) would apply to Cortex anyways--though they are already close to virtual,albeit they are running the trial(s) that will determine their fate.
NeuroInvestment
FWIW, here is my perspective on the ADHD issue, based more on clinical background than anything else, though being the parent of a teenage girl with ADHD is also instructive:
One of the difficulties underlying the debate is the illusion that ADHD is a homogenous entity/category (the same is also true of most psychiatric disorders). Besides the well-known hyperactive dimension (boys far more likely to have this variant), there are other factors. The biggest is whether or not a kid is what they are now calling a "2E" child, where there is another area wherein they are exceptional, on the upside. It can be music, drama, math, or even general intellectual excellence, but ADHD is a different entity, with a different treatment plan and prognosis, when it exists within a context of other strengths. Such a kid, particularly if they are able to see, or be directed to see, themselves in terms of those strengths instead of as being defective, will tend to be much more able to utilize behavioral strategies, and will be seen differently by teachers--which makes the school experience something more than just chronic failure.
For the brightest of these kids, ADHD seems to be associated with the capacity for innovative 'out-of-the-box-thinking.' Richard Branson of Virgin Records/Air/Etc is an excellent example of this. But I have also seen very bright children/teens for whom ADHD really undercuts their ability to channel and utilize their intellectual strengths. There's a limit to what can be accomplished with coaching and structured learning environments (and the capacity of strained public schools, or the willingness of private schools to provide the latter is limited at best). Medication makes a difference for many of these kids--it's observable, they see it, and it lets them function closer to potential.
When kids don't have concurrent strengths, that's a real dilemma, because then their identity, and identification within school systems, ends up defined by what they cannot do. There can be other learning disabilities, and school becomes a source of humiliation. This is when conduct disorders and impulse control problems can come to the forefront.
It's been known for a long time that some (and the percentage is unclear) people eventually wire up their frontal lobes and for the most part 'grow out of' their ADHD. That subgroup, if undefined in this kind of epidemiological research, can obscure the need for, and benefit from, longerterm ADHD meds. I have no doubt that there is a subgroup for whom the need does not go away after two years, if at all. You can see adults who are generally functioning OK in some areas, and would be defined by these common endpoints as 'normal.' Yet their ADHD impacts their ability to resist impulses, to not seek hyperstimulation, and their ability to see how their behavior affects others. There can be a longterm cost to relationships.
I don't think for a minute that the MTV short-attention-span texting-twittering culture causes ADHD. But to the degree to which experience, and practice, influences the plasticity of the brain, and helps the interwiring to occur, I'd agree that the current deemphasis upon sustained-attention activities and entertainment reduces the corrective impact that would otherwise have been possible. So it may make the disorder more chronic for some who otherwise might have been among those who 'grew out of it.' But this is just my opinion, if there is data to support or contradict this, I'd be interested to see it.
NeuroInvestment
Because CX717 IV would need to go through extended tox testing before going into human studies. It would take about as much money (and more time) to get CX717 IV ready for Phase I (never mind Phase II) as it will cost to do this SA POC study for CX-1739. They didn't have enough money to do both, so they went for SA--where there is infinitely more 'bang for the buck.'
As for clinical holds--I don't have a database of all holds, but they are not a 'kiss of death'.
I'm signing off for a day now--I have to leave for a meeting where I'll be on a panel being questioned about the future of neuro drug development by a group of BP neuroscientists and the like; pretty much all of whom are considerably smarter than I am. Assuming I survive that experience, I'll be back tomorrow and will look in, since the quality of discourse has improved considerably over the past 24 hours.
NeuroInvestment
I took a quick look at a database of CNS deals 1994-mid 08.
10% have resulted in a successful NDA either here or in EU.
About 42% have failed.
The rest--their fate is yet to be determined.
NeuroInvestment
That's helpful perspective, I've heard similar anecdotal reports elsewhere. The sheer volume is stunning.
NeuroInvestment
The best arguments against ADHD would be
1) CX717 isn't viable for chronic use, and CX1739 has no POC
2) the psychostimulants are sufficiently dominant that a nonstimulant will not reach sufficient sales magnitude, particularly with Strattera--and we don't actually know how CX1739 would fare against it--still controlling the nonstim sector.
Against RD:
1) The IV form of CX717 hasn't been tested in humans
2) CX1739 has no POC in RD.
Overall:
For some people, Cortex has already been defined by the clinical hold, and they aren't taking in new information.
Addendum--also, one could respond with 'we have 150 other partnership proposals on the docket, and until we look at them all, we can't be sure this is the best route to go...'
NeuroInvestment
1) OK, if you want to wait a month to conclude that my 'supposition is correct', that's up to you.
2) Look at his resumé. Then check the timeframe within which Cortex generated significantly improved compounds since his arrival.
3) This has been discussed over and over. If you haven't believed what I have said about it before, you're not going to believe it now. Surely.
NeuroInvestment
<<Going to be at least a month or two before we've got anything of substance to discuss about Cortex.>>
Probably true. If they were confident of a deal--and receipt of money--before mid-April, they would not have downsized.
One thing that has not been noted, and is perhaps important, is that the downsizing did not eliminate Les Street. Street may be the most immediately employable person at Cortex: even in a time of constriction, really good chemists are sought after. Had they laid him off, he'd have been elsewhere quite quickly. So why would Cortex want to keep him (and why would he want to stay?) if they were about to expire? After all, his role would be to produce improved chemical variations of low-impacts, either for Cortex alone or for a partnership---and to continue working on the high-impact program. Cortex would not have kept him and his salary if they were just playing out the string, and he probably would have looked to exit. They expect that there will be work for him to do at Cortex, which means they are planning to be moving ahead, not disappearing.
NeuroInvestment
Mr. Blatch:
I had specifically indicated that some readers would not derive any benefit from reading that information. Based on your apparent conclusion drawn, apparently you fall into that category.
NeuroInvestment
Now it's too close to call. I'd suggested that the cutback bought them 1-2 months, let's split the difference and say it is 6 weeks. If they could have eked it out until the end of April (which is actually a stretch I think, mid-April may have been more realistic) before downsizing, at best, this brings them to mid-June. They have cited 'mid-year' for study completion. I think it is possible it could get done a little earlier, depending on enrollment rate, and I have no idea what that will be. It's that rate that will determine whether they complete running the 20 patients on their present dime.
The wild card is magnitude of change. It is possible they could see a pattern, or lack thereof, long before the study is officially completed. And they could decide to unblind early.
As Ememem notes, the other wild card will be side effect profile. If half the patients maintain their same sleep cycle on the third night, and the other half are lying there with their eyes wide open due to insomnia, that would be the side effect issue. I am not predicting that, I think that if CX1739 had a marked awakening effect (and my understanding is that the Ampakines vary in that), this might have shown up in the safety testing, some increase in insomnia. If that had occurred, Cortex might well have decided to not roll these dice. That doesn't guarantee an absence of an insomnia side effect, since I suspect the Phase I patients were not dosed at hour of sleep. But they would have been looking for anything that looked stimulating/alerting.
NeuroInvestment
Deleted--I realized this was going down a road not worth the time.
NeuroInvestment
Lots of companies have licensing agreements surrounding their compounds--if Cortex were to be sold, I do not believe UC gets to play a part in deciding whether the licenses are included. Their rights (and deadlines) would move to the acquirer. UC does not want to get into the role of trying to resell part of the Cortex IP.
If the SA trial fails: First, I believe that, even without ADHD data for CX-1739, that there are some partnering talks going on for ADHD. There is nothing 'untouchable' at Cortex, everything can be had for a price--it is determining that price that is the problem. The value of a partnership is far higher with POC, but they could try to license CX1739 geographically, holding to US rights. So that would be the fallback plan if SA fails--and I think they'll know that early too--if there is no indication of change from the first two sleep study nights in the third, and that lack of change is seen for six or seven patients in a row, it'd be unlikely that they are all on placebo. IF that were to occur, they'd be pushing the ADHD licensing. IF that then took place, the agenda would be to get enough money to restart the AD/PD/HD high impact programs, they'd be a neurodegeneration company again. OR the ADHD licensee could just make an offer to take them out--and they'd have to bring that to the BOD. A reluctance to sell when they have both SA and ADHD possible for partnering this year could be different if it's just ADHD and AD/PD/HD, and there isn't money to bring any of it along.
As to pricing--I'd look at Memory Pharma as one indicator. Roche paid under $30 million for the 'enterprise'. But the main asset, the nicotinic program, was already licensed to Roche, they already owned the majority of it. The other programs (PDE4, PDE10, 5HT6) were of questionable value, none has any POC. So the Cortex enterprise should be valued higher.
I know what is going to happen if I state a specific figure or range. Some people are going to start moving into their castles in the sky, demanding that Cortex sell itself for $XX million now, they'd rather have the cash, etc. So I'm not going to do that. If other people want to start coming up with valuations, fine--I still expect them to do a licensing deal and to not be bought out.
NeuroInvestment
<<I think that the company has been fending off buyout offers that any of us would be happy to accept, but because of the depth of their underwater options>>
I haven't heard any gossip 'on the street' that suggests that. There was what I thought to be a possibly credible rumor a year ago that R&R was trying to engineer a fire-sale to another of their client companies. While the price level postulated at that time sounds pretty good at the moment, that was then and this is now--and a lot has changed. There are a lot of companies for sale, and assuming that Cortex is "fending off buyout offers" doesn't make sense to me. There are some larger companies that prefer biotech buyouts to partnerships, and given the prices these days, that proportion is increasing. But there are still some who state that they'd rather partner than take on all the risk.
Dew has provided a list of companies which have been sold at a premium, so that can happen. But my guess is that most of the companies that have been sold (the only one I followed was Memory)were not as close to running on fumes as Cortex is. That's a situation where a buyer is in the awkward position of figuring out if the acquisition might be a lot cheaper four weeks hence--and their superiors are going to ask the same question.
NeuroInvestment
This post is intended only for those who are not inherently allergic to factual, contextual information. Those who have an aversion or agenda which weighs against looking at the larger picture are advised to move on--there's nothing here for you.
Gfp: You're right, this is a phenomenon often seen in biotech. It occurred to me that it's not whether compound targets change over time due to failures that differentiates companies, but whether a partner had been found prior to those failures, so that capital had been brought in, and the effect of the failure diluted. Cortex has shifted from AD/MCI to DARPA to ADHD to RD/SA over time. They too have had partnerships (Servier and Organon), but neither one produced capital or success. The deal that could have been pivotal, for ADHD, was scuttled due to the 'artifact' in combination with the FDA.
Let's look at some of their peers:
1) Acadia has had at least three programs fail, and are on what at best is a third-tier focus for their lead. But one partnership with Allergan survived, and one of the failures was in a program partnered with Sepracor.
2) Cephalon at one point had an inlicensed opioid migraine drug, Myotrophin, and modafinil. The migraine drug was highly addictive and did not sell well, Myotrophin failed, but after Cephalon had sold half of the rights to an investment bank, so they absorbed half the hit. Modafinil, which was at best their second tier target, was the gold mine.
3) Neurocrine Biosciences early on had a MS drug, a CRF antagonist program, NPY modulators for obesity, and an inlicensed insomnia drug called indiplon. The MS and obesity programs failed, but they were able to partner their CRF program three times (!--Janssen, Lilly, and GSK), getting upfront money each time, and they had a megapartnership with Pfizer for indiplon. The Janssen and Lilly programs failed, the fate of the GSK partnership is unclear, and indiplon failed. Right now their lead is a gonadotrophin modulator for endometriosis, which has nothing to do with their original pipeline. They are essentially on their sixth or seventh program, but they got a lot of money from their ex-partners.
4) Targacept: Their original nicotinic program had partnerships with Aventis for AD and PD, and a German company ('Dr. Falk')for GI disorders, both end without anything eventuating. They then partnered with AstraZeneca--but the lead compound failed in AD and schizophrenia, they are waiting on ADHD results.They also have a deal with GSK, and the first program from that--just failed. They are on their at least their fourth 'carrot', depending on how you calculate it. But they have taken in cash from AZ and GSK.
I could make similar summaries for Alseres, Neurogen, Titan, TorreyPines, and several others.
It's not that the carrots change, that happens for everyone. The question is whether one could get partners to sign on and fund those new 'carrots'. And one of the consequences of all the programmatic failures noted above is that larger companies are now much more wary of making mistakes, because their jobs are hanging on the outcome much more than they were ten or fifteen years ago.
NeuroInvestment
That certainly seems probable. He may now have some idea of how quickly they have been able to enroll suitable SA patients, and if it is slower than anticipated, that could have played a role in the streamlining decision. That still leaves open the possibility of tracking the blinded data to see if a bifurcation emerges that might warrant unblinding it early.
Negotiations on SA don't have to wait until completion--they could have a term sheet or two that is predicated upon positive SA results. Just as they apparently had an ADHD term sheet that was predicated on a FDA go-ahead for CX717. So we know that any agreement that is conditional--is vulnerable.
NeuroInvestment
The one thing that this makes clear is that there isn't a deal in hand. And anything that is not in hand is not something that can be counted on. So with--five or six weeks of runway left, they had to cut the neurodegeneration program people, my guess is that this adds a month or two at most.
NeuroInvestment
<<I was also guessing that something like payment of half before the trial starts and half upon completion would be a reasonable arrangement.>>
Right. That's not deferring payment.
NeuroInvestment