Now a pacemaker type solution to sleep apnea. Not that sleep apnea has anything to do with Cortex anymore.


The standard treatment for people with moderate to severe obstructive sleep apnea is a mask worn at night that helps them breathe without interruption. The mask is unwieldy and uncomfortable, however; one study found that46 percent to 83 percent of patients with obstructive sleep apnea do not wear it diligently.

Now scientists may have found an alternative, at least for some patients: a pacemaker-like device implanted in the chest that stimulates a nerve in the jaw, helping to keep part of the upper airway open. The device, called a neurostimulator, helped reduce breathing interruptions and raise blood oxygen levels in about two-thirds of sleep apnea patients participating in a trial, researchers reported on Wednesday in The New England Journal of Medicine.

http://well.blogs.nytimes.com/2014/01/08/for-sleep-apnea-patients-a-possible-alternative-to-masks/?src=me&ref=general&_r=0

A Dry Pipeline for Psychiatric Drugs

With rare exceptions, it is hard to think of a single truly novel psychotropic drug that has emerged in the last 30 years. True, the new psychotropic drugs are generally safer and more tolerable than older prototypes, but they are no more effective. So why has the pharmaceutical industry churned out so many copycat drugs?

http://www.nytimes.com/2013/08/20/health/a-dry-pipeline-for-psychiatric-drugs.html?_r=0

Didn't realize that the Michael J. Fox Foundation had this kind of money.

Sergey Brin, the 38-year-old co- founder of Google Inc. (GOOG), is making strides in his quest to find a cure for Parkinson’s, a progressive disease his DNA and family history suggest may afflict him as early as 10 years from now. So far Brin has donated $132 million, mostly through the Michael J. Fox Foundation for Parkinson’s Research,

http://www.bloomberg.com/news/2012-05-11/google-s-brin-makes-strides-in-hunt-for-parkinson-s-cure-health.html

Attention Problems May Be Sleep-Related

Many children are given a diagnosis of A.D.H.D., researchers say, when in fact they have another problem: a sleep disorder, like sleep apnea. The confusion may account for a significant number of A.D.H.D. cases in children, and the drugs used to treat them may only be exacerbating the problem.

http://well.blogs.nytimes.com/2012/04/16/attention-problems-may-be-sleep-related/

Yep, just cannot believe compounds that counteract opiod induced RD are being ignored - sign of the times for the US pharma industry.

Interesting BDNF article.

http://well.blogs.nytimes.com/2011/11/30/how-exercise-benefits-the-brain/?src=me&ref=general

This is an interesting development in biotech funding. Big pharma does not want to do partnerships, instead they do venture capital. I guess with the market caps of biotechs so low, it makes no sense to give a company millions up front in a traditional partnership deal when you can almost buy the whole company for the same price.

Corporate venture funds boost biotech startups

http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2011/11/15/BUG71LU5MP.DTL

Wasn't there also something about low blood oxygen levels in sickle cell patients to start with?

I too am totally mystified why nobody seems to be interested in RD. Really think it says something about the state of the pharma industry today.

Someone please remind my of what Cortex's angle on sickle cell was? Was it just that patients get a lot of opiates during these crises?

Drug deaths now outnumber traffic fatalities in U.S., data show
Fueling the surge are prescription pain and anxiety drugs that are potent, highly addictive and especially dangerous when combined with one another or with other drugs or alcohol.


http://www.latimes.com/news/local/la-me-drugs-epidemic-20110918,0,5517691.story

Sounds like he is talking about the drug Sutent. But I don't get the rhyme with 'Mergers and Massacres'.

Dew, Check this out - this Milkshake piece made Naked Capitalism.

http://orgprepdaily.wordpress.com/2011/09/06/the-taste-of-their-own-medicine/

If Servier is willing to pay $3 million for this one molecule, why don't they just buy the whole company? Any way this could be some kind of prelude to a Servier buy out?

I think this is great news. At least somebody has at least some little bit of interest in ampakines. They haven't 'sold the farm'. This is just one molecule that they didn't have complete control of anyway. Really makes you wonder what Servier is seeing in their trials.

I was so sure that no way I could lose loading up on Cortex at 30 cents.

OMG! Market cap down to $6.5 million. Am really starting to understand what the term 'value trap' means. If it seems too cheap to sell at a market cap of $10 million, how are you going to be able to get yourself to sell at $6.5 million? Two years ago they could sell the RD indication for $10 million, now the whole company is worth a little more than half that?

This is getting to the point where management could all get together and sell their fancy San Diego homes and take the company private.

My favorite biotech near death experience was when the CEO of Insite Vision, Kumar Chandrasakarian mortgaged his Berkeley home to lend the company $800 K. That guy was a true believer. Got his money back in the next financing, but lost control of the company to some investment fund sharks and was booted. Company is doing O.K. now, mostly due to stuff Chandrasakarian put in place.

Biotech is so universally hated now, starting to think that I should force myself to start getting back in. Can this nuclear winter last forever?

Here is interesting Bloomberg article on Valeant. Love these McKinsey guys.

Pearson’s strategy and viewpoint on research costs have been consistent. When he combined Valeant with drugmaker Biovail Corp. in September, he cut about 25 percent of the workforce, sliced research spending and established a performance-based pay model tied to Valeant’s market value.

“I recognize that many of you did not sign up for either this strategy or operating philosophy,” Pearson wrote in a letter to staff at the time. “Many of you may choose not to continue to work for the new Valeant.”

http://www.bloomberg.com/news/2011-04-07/valeant-ceo-spurns-drug-research-for-deals-with-cephalon-fight.html

Like your sense of humour.

Gfp, So are the CX-1739 preclinical studies now done? Could they now really move ahead with an ADHD trial if they had the money? This makes a huge difference to how one should value this company. Are they really, truly ADHD-trial-ready? Or maybe they think they need to do some long term monkey studies, just to be sure of getting the FDA nod to proceed with a trial?

Love the 127 Hours analogy. Just did one of those 14 hour cross Pacific flights, and everyone was watching that movie on their back-of-the seat video screens. Very gross to catch glimpses of that movie for 14 hours.

Well, congratulations for getting out. Interesting to know what it takes to unload 70,000 shares.

Everybody's talking about getting the RD rights back. It is not like Cortex can come up with $10 million to buy the rights back. So is the assumption that the RD rights are worth much less than $10 million now? Or that some kind of royalty arrangement can be worked out? Here is their chance to finally in-license a promising drug like they have been talking about for years.

Or maybe there will be some complex deal where a partner buys the rights back while simultaneously picking up new compounds from Cortex?

Arena recently had the same experience with their obesity drug - FDA rejection after a massive PIII effort. Amazing to consider the time an money pissed away on these drugs. Not to mention the patient's and doctor's time wasted in the effort. This whole industry is broken. That is my only justification for investing here - as a contrarian play. This must be the bottom of the cycle, because how could things get any worse?

Results were about as good as could be expected for such a small study on such an tricky indication. Certainly gives more support to the RD indication - which was sold off for less than the developement cost. Does somebody have the final count on how long this took?

Study results seem pretty much in line with what this board expected: muddled, with some hints of efficacy - but the stuff keeps you awake. Interesting that the subjects were able to sleep as well as they did. Didn't the stuff tested in the DARPA study keep people wide awake? Or effects were more subtle than that?

Interesting genetic study on autism by John Hussman - a fund manager who does autism research in his spare time. He writes a great weekly investing commentary too.

We didn't set out to look for "the" autism gene - the evidence suggests that there is no such thing. There may be hundreds of autism susceptibility genes. Any particular gene may have weak effect in a large number of individuals, or a strong effect in a small number of individuals, but in either case, the overall signal you get at the population level is almost always weak. So instead of trying to find one elusive gene, we were interested in whether there might be some biological "pathway" that was enriched with numerous candidate genes. When a specific biological pathway is involved in a disease, genetic signals that are relatively subtle on their own can combine to form a composite signal with very high statistical significance.


....Not all of the proteins had literature about their function, but of 183 autism candidates that were responsible for the 20 highest-scoring functional categories, 41.5% had established roles in the regulation of neurite outgrowth and guidance, including 51.3% of the "cell adhesion" candidates. Notably, all of this was consistent with neuroanatomical evidence. When researchers have examined actual brain tissue in individuals with autism, one of the most consistent findings in the literature has been alteration of dendritic structure. It just wasn't clear whether that was a cause or an effect.

http://www.hussman.net/wmc/wmc110131.htm

Was surprised to learn that another growing use of gas as a transporation fuel is as LNG. On a recent GTLS (Chart Industries) conference call heard that one of their fastest growing markets is LNG systems for heavy duty trucks. That's right, LNG, not CNG. LNG gives trucks much greater range (compared to CNG). There are plans for converting the giant fleet of trucks carrying coal from north east China and Mongolia to LNG, converting city buses, and also converting Yangtze River cargo ships. Was fun to hear CEO talk about your average midsized Chinese city of 6 to 8 million, with a municipal bus fleet of 30,000 buses.

Believe that converting to LNG takes about 15% of the initial energy. Not sure how that compares to gas to liquids. Should also look into how the capex compares. Making LNG has got to be much cheaper.

If gas stays cheap people are going to find lots of ways to use it.

Appears that Varney was taken by surprise by the SA data. The trial probably turned out to be a total fiasco with useless data - something like the RD trial where the face masks were not fitted right. They are struggling to salvage something from it. Could take quite a while before they give up and admit failure.

Really amazing that the $10 million from the RD give away apparently is not enough to even start an ADHD trial. Weren't we thinking at the time that the RD $10 million would easily get them through and ADHD trial identical to the previous trial?

I think the trial produced nothing, and they are trying to maintain share price while they figure out an exit strategy.

I used to think faliure in the SA trial would not hurt the stock much, as the ADHD trial was the great white hope. But now that ADHD has stalled, it looks like the SA trial has become the focus.

Maybe they are trying to withhold the SA flop until they can file the ADHD IND? So really we should be speculating on what the hold up is with ADHD.

How much longer is this biotech nuclear winter going to last? Maybe it is going to end with Korean and Chinese companies buying up the valuable scraps?

Really curious to see if Lynch's intermittent dosing idea will be used in these Servier phase I trials. On the other hand, probably this will a pure safety trial - they will just give subjects one dose and see how bad the side effects are.

Wouldn't it take an extended trial to see any benefits with a BDNF enhancing approach? Is there any way to see if the subjects BDNF levels increased?

There was some discussion previously that the intermittent dosing idea allows you to use compounds with a low half life. Maybe it even requires a low half life?

This cormean character does have a point that the stock is not too liquid. 14k shares traded today and the stock is at a 6 month high. Makes you wonder if there are multiple equilibrium prices possible. Maybe we could just as easily be trading at 30 cents or 40 cents?

Interesting that Cortex is 'having discussions' with Valent. What would there be to talk about? Wonder how much is would cost to buy back this indication?

Speaking of Zebra's law, recently did a hiking trip in Utah with the true source for this 'law'. Got an incredibly depressing seven day earful on the sorry state of pharmaceutical research in the US: The horribly de-motivating bureaucratic infighting and organizational chaos at big pharma labs (e.g. Pfizer). The migration of pharma chemistry to China, The absurd glut of chemistry Ph.D.s churned out by US universities. The shear idiocy of the focus on block busters strategy, The neglect of in vivo models, The lack of understanding of the key role that serendipity plays in drug development, etc. etc.

Scenery was great though.

Yes, looks like we are entering a pump and dump action. Could be a great liquidity event to sell out. But if I follow my usual pattern during these things, I won't be able bring myself to sell. As a true believer you become convinced that the market is finally recognizing the incredible value of your long held penny stock. Then a week later as the stock price drops back, you feel like and idiot for being fooled yet again.

All we get out of it in the end is a bunch of underwater newbies who just got into the stock whining on the board.

Agreed. We also don't have any idea what data Cortex actually has in hand and when they received it. Don't they get a few days to check the statistics and write up a press release?

That said, I am enjoying Davidal's fugue state. This has been such a frustrating company. Hard to walk away, because the ampakine platform has got to be worth more than a measly $13 million (current market cap). But when you think about possible paths forward it seems completely hopeless.

Still think the SA trial design was a huge mistake. Odds are that patients that had similar SA two nights in a row did so by pure chance.

Maybe Cortex could inlicense the RD indication from Bioval.

Seems like we are hearing a new argument that they have to have all the funds in place to run the whole trial before they can start the trial? I thought the old plan was to just start the trial and bet that they will be able to raise money along the way.

October, Novemeber, December? I thought that was some Cortex black humour.

Would love to know the details of why Merck gave back these rights. There is no mention of Merck retaining any royalties or buy back options. So I assume there was some clause in the original deal about an active development being required to maintain the rights?

In most cases it is a bad sign when a partner hands you back your compounds or indications. But this is the exception.

Think we've discussed this before, but it sounds like there is a very real probability that subjects who showed similar SA on both 'calibration' nights, did so just by chance. Really bugged by that part of the trial design.

gfp, Thanks, that makes sense. Jeez, I now look back fondly on our old euro-sloth partners Organon and Servier. Almost anything is better than the disfunctional U.S. pharma culture.

Speaking of Merck's compounds, has there been any hints about retrieving the schizo rights?