Cortex Pharmaceuticals: Commentary

(Online comment 10/6/08)

Cortex Pharma and Respiratory Depression

Cortex Pharmaceuticals reported very solid efficacy data from their second trial of CX717 in respiratory depression, showing that the drug both prevents RD and (iunlike naloxone, the current treatment for opioid-induced RD) preserves analgesia. This will allow anesthesiologists to not have to subject patients to unmedicated post-surgical pain if respiratory depression occurs--and it occurs far more often than we had ever thought. The incidence varies by setting, and Cortex reports it may be as high as 17%, we think it can be safely estimated as being in the low double-digits--enough to be a safety, quality of care, and liability issue. Given that the data suggests this risk can be avoided via prophylaxis with CX717, we believe that once commercialized, CX717 (or a second-generation Ampakine) will become the new standard-of-care, because no anesthesiologist or hospital will want to justify a patient exposed to either the risk of death or of physically traumatizing and dangerous levels of pain.

Respiratory depression is not something with which NI was familiar when the concept of Ampakine usage therein was first floated last year. But it is familiar to front-line ER docs and surgeons. We witnessed this first hand when speaking with John Greer, who has pioneered the work in this area, at a professional meeting. During the 30 minutes we spoke in front of his poster, three MDs came up at various points, and spontaneously expressed the wish that they had CX717 in their armamentarium. By a rough calculation of the number of crash carts and surgical suites that would have to be equipped with CX717 in the US, NI's estimate a few months back was that just this market alone would be worth $700-800 million annually in the US (due to expirations, restocking would be necessary at least yearly). Cortex and Greer are also looking at the possibility that CX717 might be the first drug to directly address the respiratory issues in sleep apnea, which would jump the annual potential two to three fold, at least.

But beyond this, the Ampakine/RD scenario has one additonal, huge area of potential: the licensing company could develop a combination opioid/Ampakine drug which, via any delivery modality, would be differentiated from all other opioid formulations by this safety margin--the impossibility of inducing respiratory depression. In a nociceptive pain market where the gold standard opioids are almost indistinguishable from each other, and major efforts are going into various permutations of altering duration of effect and vulnerability to abuse, this would represent a unique marketing advantage--and one that no generic could approach for many years.

There is no competing MOA on the horizon, and indeed the role of AMPA circuits in the respiratory Pre-Botzinger Complex may be uniquely suited to this role. We expect that these very clear, clean data will stimulate a very competitive bidding situation vis-a-vis a partnership for Cortex.

(Online 8/6/08)

Cortex today presented Phase IIa data for CX717 in Respiratory Depression. The highest dose (2100mg) hit statistical significance in its effect on RD, even though only seven patients were assessed. The two lower doses did not produce valid data due to 'procedural errors', which does not reflect well on the CRO that did the trial. Had the DSMB not stepped in and revised the execution of the last and highest dose, the trial might have produced a false negative result. But this does provide the POC Cortex needed: the animal models were indeed predictive of human response, even though the experimental model itself had to be revised to meet human subjects safety standards. This makes CX717 and its IV version (and IV successor CX1942) a unique competitor for the highly problematic use of naloxone in cases of opiate induced RD. Adding in the potential of an oral adjunct that prevents RD in ongoing opiate analgesia, which would provide a distinct competitive advantage for the analgesia company marketing it, and one can expect an active partnering environment. Discussions have clearly already been underway, and Cortex's understated CEO was unusually optimistic in discussing prospects for a deal, A second Phase IIa trial will report in the next few weeks, and could potentially (assuming that group carried out the protocol correctly) add to the POC, including the demonstration of analgesia-maintenance.

NI's take is that over the next four months, Cortex will be choosing from three options:
1) A RD only deal for CX717, CX1942, and a low-impact-yet-to-be-named
2) A low-impact deal which covers RD and ADHD, which takes CX1739 as well. Otherwise, Cortex will bring CX1739 into ADHD trials next year.
3) A buyout offer. For example, Cephalon looks like a rational choice given their strong interests in both analgesia and ADHD. They need to update and upgrade their portfolio due to patent expirations. Over Cephalon's history, their preference appears to be to acquire rather than to license. There have been exceptions, but the license for Provigil was followed by the acquisition of Lafon, Actiq was via acquisition, so was their oncology franchise.

In any of these scenarios, Cortex's chronic cash problems will be alleviated, and (unless acquired outright) they will have the resources to develop their 'high-impact' neurotrophic platform for Alzheimer's, Parkinson's, and Huntington's. The recent damage done to the primacy of the amyloid hypothesis will raise the value of such 'ideology-free' strategies for AD--i.e. approaches that do not depend upon a specific causal model for therapeutic effect. RD, ADHD, and neurodegeneration together make for a company valuation far above the $37 million where they started the day.

(from NI July/August 2008; added 7/9/08)

Surely having run through many of its proverbial, feline nine lives, Cortex came back strongly during the 1H:08 based on anticipation of the potential for Ampakines in treating and/or preventing respiratory depression. But the results from the first German Phase IIa trial were delayed to the end of July, when the analgesia-maintenance trial will also have data released. The use of a drug preventing RD has at least $1 billion potential in analgesia contexts, while company-sponsored market study suggested that sleep apnea as an indication could more than triple that potential. Our view is that there are two aspects: Nearterm, there is a (primarily) hospital-based market for a RD-preventative. RD's incidence is quite a bit higher than we had initially thought, apparently approaching 13%. But the second, longerterm application would be in chronic outpatient use: The analgesia company that combines an Ampakine (probably not CX717) with their opioid analgesic, and can market it as a safer painkiller for severe pain, will have a distinct advantage where competition has tended to revolve around extending the duration of release and discouraging abuse. We expect that companies with prominent pain franchises are going to be avid bidders for the RD program, as much to keep it out of a competitor's hands as to have it themselves. Assuming trial success, which is probable but not assured, that partnership should take care of Cortex's perennial cash flow problems.

In terms of its core business, which remains neuropsychiatric, Cortex also has made progress in broadening and deepening its pipeline. CX1739 is nearly ready for Phase I, with CX1942 (a CX1763 prodrug) going into full toxicology studies. CX1739 could be in Phase II for ADHD and Alzheimer's within nine months. Schering-Plough has moved Org26576 (which falls under the Cortex partnership) into Phase II trials in both depression and ADHD, with data coming in early 2009. Perhaps more importantly, the neurotrophically 'high-impact' CX1837 could be in Phase I during 2Q:09 as well. In terms of addressing the neurodegenerative disorders that were Cortex's original raison d'être, that is a potential landmark event. We would be surprised if this does not yield a neuro/psychiatric partnership with a Big Pharma within the next 6-12 months, but we have said that before.

(from NI January 2008)

Comment 1: Having recovered from Neurology's imposition of a clinical hold on CX717, a hold that was lifted, with dose limitations subsequently removed as well, Cortex was battered when the FDA's Psychiatry Division refused to allow their IND for ADHD. As has been discussed at length in NI, the refusal appears to be fear-driven; the fear that the post-mortem artifact cleared in the eyes of Neurology might eventually prove to be a genuine problem, a risk they were not willing to take with ADHD. The stock price was savaged, a process inflamed by Rodman & Renshaw's call for the quick sale of the company, and a bizarre price target of 30 cents (!). On the positive side, CX717 and other Ampakines were found by a U. Alberta group to provide unique and highly specific activation of normal respiration via AMPA receptors in the pre-Botzinger Complex. The specific application would be in the treatment of analgesic-induced respiratory depression, where CX717 appears (in four species so far) to restore respiration without attenuating analgesia. A Phase IIa trial will begin this month in Germany. Cortex also made progress with other compounds, bringing CX701 close to its IND, and developing 'high-impact' neurotrophic compounds that are not epileptogenic (unlike many of the high impacts developed elsewhere, like Lilly). This opens the door to partnering for neurodegenerative conditions.

Comment 2: In the past two years, Cortex has had two setbacks, the CX717 artifact and the IND rejection, which have twice completely blown up solid share appreciation. Had the first not occurred, the second never would have, and the share price would be near 10. Every company has bad luck and unexpected setbacks, but Cortex seems to have had more than its share. Will this be the year their luck changes? Or are they forever snakebitten? With high probability of success with the respiratory depression program, and some resolution of Schering-Plough's Ampakine intentions, we believe that it will be the former, Of course, we have said that every year since 1946, or so it sometimes seems. Our target is 5; set low because Cortex also has the burden of swimming upstream against the wishes of their former banker, and because some degree of battle fatigure has set in. If they reach that price level, we suspect that they might be amenable to a buyout, and with a high-impact Ampakine now approaching the clinic by year-end, we cannot believe that there is not a Big Pharma out there smart enough to know a bargain platform when they see one.

(from NI November, added 11/2/07)

Lilly and XenoPort veteran to be their CMO, which indicates that they are not in retreat-mode. It also appears that Rodman & Renshaw is punishing Cortex for not using them as the main placement agent for the last financing: R&R revised its target to 30 cents (!) and is demanding that the company be sold (so that they can receive a broker commission). R&R's math contradicted itself in the telling, which is why we believe that this is punitive.

(NI comment 10/11/07)

The ADHD indication which had looked so promising for CX717, is dead. Psychiatry apparently made it clear that they would not consider opening themselves up to criticism from higher powers (e.g. Charles Grassley) for allowing clinical trials in ADHD with a drug where any safety questions had been raised--even if now answered in the negative. ADHD has effective albeit imperfect (safety problems) therapies already available. Ironically, neither Adderall, Ritalin, or Strattera would be allowed into the clinic today, given the contemporary climate of avoiding any risk of criticism. CX717 is still highly viable for the Respiratory Depression indication, and Cortex needs to accelerate European trials ASAP in order to establish human POC. CX701 will probably be the compound of choice for chronic disorders, though we would not bother with ADHD with another Ampakines for the time (years) being. With the worst outcome having occurred with Psychiatry, the recent financing that we criticized quite strongly turns out to have been wise insurance. Without it, Cortex would not have been able to enter RD Phase II with CX717. With the money on hand, they can. Obviously, this scuttles all discussion of a major BP deal. The next opportunity for a partnership could come during 2H:08, when they have human POC data for Respiratory Depression. If it works as it did in animals, companies with heavy reliance upon opioid analgesics for revenue will be very interested.

(Post CC 9/21/07)

A major focus of the CC was the emerging possibility of low-impact Ampakines as adjuncts in opioid analgesia, preventing and/or ameliorating respiratory depression. It is an acute-care context which has a lot of appeal from a clinical development point of view--quicker, objective endpoints. The question is whether a single company will take on both ADHD and RD with a CX717 deal--one can see Cephalon, JNJ, Shire, Novartis, as companies with dual agendas therein. If CX717 were partnered away for ADHD but not RD, this might be the only context wherein the disgraced CX516 might have the opportunity of making a comeback. CX516 has lousy potency--at least as an oral drug--and a short half-life. The unanswered question is--if administered along with or following an opioid via injection/infusion, skipping the GI absorption barrier, does it have enough BBB penetration? There is lots of human data--600 or 700 humans have taken CX516, and some for extended periods, certainly enough to make a single infusion seem like a probably safe thing. The unknown is whether administering a fairly large bolus IV, for example, might be irritating to the vasculature, or involve some other side effect issue you wouldn't see with oral dosing. CX516 actually has a time advantage even over CX717, because of the extensive human testing database--and if Cortex does indeed partner CX717 (and perhaps CX701) I think CX516 might--might--be a backup option.Hopefully, Cortex will run a few rodents through an IV CX516 study just to see if they can get likely necessary levels and with acceptable side effects.

Two other Respiratory Depression points:

1) When thinking about risk, one risk is that a nonopioid analgesic (say a VR-1 or N-type CA channel blocker) is developed that has equal analgesic power. Nothing is beyond PhI at this point, but if that were to occur, the need for an RD therapeutic would likely vanish, neither of those approaches are thought to lead to RD (though it is still early). This argues against Cortex trying to take it all the way through, you don't want them holding an anachronism at the end.
2) On the other hand: Look at what New River accomplished with Vyvanse. It's not abuse-proof, but it is safer, with a lower risk of OD. Though it has a higher rate of side effects. Yet the prospect of this emerging as a competitor to Adderall XR so freaked out Shire that they paid $2.4 billion for NR (which also included an opioid). Far more than it deserved, but Shire was trying to protect its turf against a potentially safer competitor. Now--the corollary situation would be Cephalon. They are trying to protect their fentanyl franchise, Actiq being replaced by Fentora. If a competitor came up with an RD-proof fentanyl combo (and fentanyl itself is generic), that would pose the same threat to Cephalon and Fentora as Vyvanse did to Shire's Adderall. Now, Cephalon is not as dependent on Fentora as Shire is on Adderall XR, but still--they can't afford to have a clearly safer competitor come up against their fentanyl franchise. Hmmmm.

(Financing deal Revisited 8/29/07)

I looked back over the past six months of financings for US traded, neuro-oriented companies without any products on the market--the best comparator group, and the only one I know. They are listed below, with a revised perspective following:

Acadia Pharmaceuticals: (4/07) Sold 5.8 million shares at 15.50: the price was 15.02 when they announced the offering. So it was priced at market, which actually increased. No warrants. They sold after good ACP-103 news.

Corcept: (August 07): Sold 4.8 million shares at 2.10. The high on the previous trading day was 2.55, closed at 2.34. Thus the discount compared to the close was 10%. No warrants.

Curis (Aug 07): Sold 12.2 million shares and warrant units at 1.06/share, just above the previous day close of 1.03. So there were warrants, but no discount.

Memory Pharma (June 07): 694K shares sold to Stanley Medical Research at a 17% Premium to the 10 day average. No warrants.

Alseres: (Mar 07) Borrowed $15 million (debt has its own special risks) at 5% annual interest, convertible at 2.50 per share. Closing price previous day was 2.14.

Titan: (Mar 07) $25 million equity line of credit, shares to be sold at a 4-7% discount. No warrants.

Amarin (June 07): Sold 6.16 million shares at market price of May 31, plus warrants. Additional shares can be sold at 4% discount.

Bottom Line: No one gave a discount anywhere near the 25% Cortex did. 10% was the next worst, and that had no warrants attached. Warrants were used in a minority of cases, all of which involved much better pricing for the shares sold. Roger Stoll performed very well in handling the clinical hold issue, which was central to the survival of the company. This financing certainly comes with a cloud attached, and our initial reaction was highly negative. In reviewing it, and asking around the industry, it does appear that there is a lot of uncertainty as to whether the financing window will close still further, and the climate appears to have changed even since the most recent of the above cited deals. While there is money to be had--and deals are not automatically being pulled yet--terms are tightening. Stoll decided he didn't want to take the chance that the window would close, and be faced with some type of recalcitrance at the FDA. Running out of money in January would not make for healthy partnership negotiations. Now he has around $21 million--enough to proceed regardless of regulatory hiccups.

(FDA Decision Announcement revised 7/19/07)

The FDA decision was everything one could have asked for--a release of the dosing restrictions on CX717. At this time, the only trial within the Neurology section's purview is the Alzheimer's study, and they have OK'd all the dosing range Cortex wanted to use in that trial. That's as good as it could get. The dosing range for ADHD has not yet defined or applied for yet, to an entirely different section of the FDA (Psychiatry), but this opens the door to 1200mg, which gives them enough 'headroom' for a full Phase IIb in ADHD as well, though this will require submission and approval of the IND by Psychiatry this quarter. The current maximum preclinical tox exposure is 3 months, which will be the framework (depending on how much of a buffer Psychiatry wants) for determining how long the ADHD study can go for. The PR's reference to completing the tox review is in our opinion a formality--'we'll let you know if we have any questions, but what we have read is sufficient to tell us there isnt a toxicology/safety problem here, go ahead'. Now Cortex can complete the IND application to Psychiatry--probably around the end of summer. We expect that the IND will be approved, albeit perhaps with a modest limitation (4 or 6 weeks) on the duration of dosing.

This is enough to allow not only the Alzheimer's trial to resume in full--but more importantly, represents the 'clean bill of health' that is needed for the ADHD partnership discussions to go ahead.

This is most excellent news for Cortex. Given the inflation of deal valuations seen of late, the prospects for an Ampakine deal may well involve terms that could exceed those that might have been obtainable last year. The next 2 to 3 quarters will be fun to watch indeed. There is not a more valuable partnership/licensing/acquisition target in the CNS space than Cortex represents at this point.

(from NI July/August 07)

Cortex is still waiting for the FDA to read through the coffin-sized box of data sent to establish the fact that the 'tox finding' was an artifact. We expect the dose-restriction to be lifted--probably late in July, since the FDA tends to be late with everything, and they are prioritizing projects which have PDUFA mandated timeframes involved. That will allow the ADHD licensing auction to move ahead. The inlicensing process appears to be slow, which is a good thing. Cortex did sign an IP deal with University of Alberta regarding the use of Ampakines in respiratory depression. The CX701 IND is in queue, awaiting completion of animal tox report.Target is raised to 8.

On-line comment, 5/10/07

The very old Saturday Night Live skit (back when SNL was funny) 'Short Attention Span Theatre' came to mind as Cortex's recent price recovery sold off somewhat in the wake of a webcast presentation that had not one iota of bad news--but no immediate gratification either. The nearterm value drivers--FDA lifting of the CX717 dosing limits; corporate partnerships for CX717 and/or the neurotrophic 'hi-impact' portfolio could not be pulled out of a hat on cue. While momentum players quickly exited in their search for immediate reinforcement, all of these event will occur--the first, within the next six weeks, the other two before year-end--and NI's ongoing description of Cortex as being the single best partnering/acquisition target in the CNS space will look more prescient than it does at the moment. Cortex is doing its homework: expanding its range of molecules under development, demonstrating Ampakine value in such untreated but devastating disorders as Huntington's (where Amarin recently saw Miraxion fail in Phase III) and Rett's. They have also shown Ampakine value in restoring respiratory function in opiate overdose and Rett's--adding yet another potential use to the broad list already in place. NI's target for Cortex during 2007 has been maintained at 6. Though it would be superfluous to alter it at the moment, we expect that before the end of the year, that will look conservative.

On-line comment, 3/12/07

What does Schering-Plough's surprising--and seemingly exorbitant--acquisition of Organon mean for Cortex? That's not yet clear, but all the possibilities are favorable for Cortex, there is no cloud to accompany this silver lining.

1) Fred Hassan buying Organon from Akzo Nobel is like the hare making a purchase from the tortoise--watching Organon develop Org24448/CX717 has been like watching paint dry, an activity with which Akzo Nobel is well accustomed. No matter what Hassan does, he'll do it fast, not just faster than Organon, but more quickly than any other Big Pharma CEO would.

2) Is Schering-Plough really moving back into CNS? Given their complete lack of a CNS program, acquiring Organon's science/lab capabilities (which are not subpar) as well as some pipeline components, this would be an interesting first step. Asenapine is not the answer to anything, other than to analysts worried about SP meeting its quarterly earnings estimates in 2010...

3) Anytime someone pays $14.4 billion for anything (he could have had AstonMartin for under a billion), people are going to closely examine what was obtained with the money. This is going to get an unprecedented level of attention cast upon the Cortex/Organon partnership, and the Ampakine programs in schizophrenia and attention. This is an unmitigated boon for Cortex.

4) Schering-Plough could conceivably decide to not move into CNS, in which case the rights to sz and depression could conceivably be offered back to Cortex for future milestones/royalties, etc.

5) But if Fred Hassan is as smart as everyone says he is, he could round up his costs to an even $15 billion just by buying Cortex for $600 million. He would then have the best Ampakine program in the world, all indications, all territories, all the IP control. That would be as quick a way to get Schering-Plough into the CNS 'game' as there is. We are not predicting this..yet. But as the dust settles and SP looks at what it now has, this is an obvious step for consideration. SP could have Phase IIb going for the best next candidate for ADHD, and Phase III for what may be the next great generation of schizophrenia drugs. And that's before you even start talking neurodegeneration and the high impacts....Lilly has to be watching and wondering..the same with Merck, where Lilly's former neuro/Ampa chief is now running neuroscience.

This could get very interesting.

From NI March 07, posted 3/10/07

Cortex's CEO announced, with uncharacteristic confidence, that he believes that the evidence for CX717 will lead the FDA to lift dosing restrictions. The electron microscopy confirmed what the histopathological examination had indicated would be found in sections that were frozen--nothing at all. The cellular/structural anomaly is a post-mortem artifact, an interaction between high doses of CX717 and fixatives. This was presented on the day that the FDA ruled that all current ADHD drugs must include a pamphlet warning patients of their side effects. The irony should not be lost on the FDA, given that CX717 has shown no cardio or abuse risks thus far. The early data to us suggests that it will be better than Strattera, safer than stimulants. With Provigil having gone to the ADHD sidelines save for off-label use, CX717 could be the most promising ADHD medication in development. This will make Cortex rather popular, now that the spectre of dose limitation appears on its way out. Cortex still needs to file the data packet with the FDA, and the FDA will respond within 60 days, likely in mid-May. As irrational as the FDA can sometimes be, there is no reason to preclude CX717 from going into Phase IIb.

The share price responded healthily to the news, though some observers still want the official word from the FDA. The next few months will be extremely busy for Cortex: Besides the data submission, they have to file an IND with the Psychiatry diivision so that they can start ADHD trials again. They also have narrowed down the inlicensing choices to three, and could finalize something within the next month or two. Our preference would be that they hold off, our hope is that when they announce the licensing, it will become clear why they did not. Licensing talks regarding the hi-impact platform also continue, and an early 3Q deal could eventuate. But the big package would be for CX717, which we believe has more value right now for ADHD than anything else. The main question is how much else is rolled into that deal--from Alzheimer's to high-impacts. There is no CNS platform currently available that can match this one. It is also worth keeping an eye on Organon, given that they must make their case for a lofty IPO valuation, may have to say something about the Org24448 data in schizophrenia, and the enrollment-recently-concluded trial in depression. With 80-90% confidence that the FDA will do the right thing here, our target is 6.

Online comment 2/22/07

From NI, January 2007

Talk about bipolar years. In March Cortex was looking very healthy, based on surprisingly strong PhIIa ADHD data for CX717 and a bevy of advanced stage partnership discussions. A few weeks later, an ambiguous cellular finding in one monkey out of twelve caused CX717 to be placed on clinical hold by the FDA. The hold lasted about six months, but continued dosing limitations left a substantial cloud over CX717, Cortex's only clinical-stage compound. Other events during the year were eclipsed by these events: a DARPA-sponsored sleep deprivation Phase II failed, largely because DARPA's trial design included allowing subjects to nap. More importantly, near year-end, Cortex took back its neurodegeneration rights from Servier, who had held them outside of North America. This will allow them to partner for Alzheimer's, Parkinson's, and other neurodegenerative disorders, on the basis of worldwide rights. The high-impact program is still a year away from the clinic, but preclinical testing with a prototype showed encouraging functional effects in models of Fragile X and Huntington's. By year-end, Cortex was near choosing a non-Ampakine program for inlicensing, with the worthy goal of diversifying to reduce risk, though the timing was suboptimal. Organon has still not released any of the data they have for Org24448 in schizophrenia, and it appears that they are very preoccupied with their post-Pfizer problems as they try to move towards spinning off from Akzo Nobel. With this many key elements still unknown, projecting 2007 is more difficult for this company than for any other that we follow. Our best guess at this time is that the FDA will allow CX717 to resume ADHD testing at the necessary higher doses, which will then turn into a partnership encompassing CX717 and high-impacts, the former largely for ADHD (though Alzheimer's remains a target as well), the latter for Alzheimer's and Parkinson's. Cortex will finally be able to pick up where they left off last spring.

Post 12/6/06 Bank of Montreal presentation:

Cortex was able to defragment the Balkanized rights for neurodegenerative disease--they now have regained Servier's (outside North America) rights. Servier can try to develop one of the collaboratively-developed compounds to sell in their territory, but we believe they have a very small chance of success (their current lead, S18986, recently had its PhII trial in MCI halted due to toxicity, and is probably dead). And it would be in error to conclude that Servier had lost interest in AMPA modulators and simply relinquished them--such was not the case. More importantly, Cortex can now partner with a Big Pharma for neurodegeneration world-wide--including the high-impact compounds now in lead optimization. This is far more marketable than the slice of pie--North America--they could previously offer. This is a major development in terms of accessing a substantive BP partnership-the word 'worldwide' means a lot to major companies, and the earlier situation had been a deterrent to a Class A partnership. In spite of the inevitable problems that have arisen in the development of the Ampakine platform--as has been the case with every major CNS platform--we continue to see AMPA modulation as the single most valuable platform currently available for licensing/partnering/acquisition.

Secondly, Cortex reported early mouse findings for both Fragile X and Huntington's. Not only did the high--impact CX929 normalize electrophyiological activity and BDNF levels, but it produced improved dendritic growth in the Fragile X model, and appears to be improving survival in HD mice. All mouse findings must be taken with salt, but this is exactly what one would hope to see.

There was essentially no real new news on the CX717/low-impact slate--we are still waiting until Jan/Feb to see if CX717 is viable for AD, ADHD, both, or neither. However, Roger Stoll stated that some company consultants still think that the cellular signal could be an artifact--this chapter is not yet closed. We continue to believe that CX717 will return to clinical trials in ADHD--which would be a large partnering opportunity in itself, given that it has shown proof of principle in Phase IIa.