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Recently, I refused to change a patient's pain medication from Percocet to Methadone(she was obese with sleep apnea and asthma). She got a new doctor(a pain physician) who placed her on Methadone at about 30mg a day. Two days later I was consulted on her in the hospital for overdosage(she came close to death). She told me she took an extra tablet or 40mg a day on the first day. For the most part, Methadone and similar long acting opiote drugs scare me.
ot... it was 18 degrees this a.m. in Little Rock. Think we broke a record. Heard there was an earthquake in Chicago this a.m. ! What's next? Dogs and Cats sleeping together? LLY and Cortex partnering?
OT. Little Rock, Arkansas. Just got six inches of snow/ice.... our worst winter in ten years.
OT, add me to the former Chicagoland list: Gary, Indiana in 'da region' next to the south side of Chicago and receiver of all that awful lake effect snow. I remember the blizzard of '79. The bitter lake wind in winter is not for the faint of heart. I only visit in the summer.
Frankly, if it gets so bad that one has to hoard cash(or even gold), then I'm not sure what to do? Vegas? One last tango??
If things get so bad that one should avoid cash/bank accounts, then I do have a suggestion: Xanax/Xyprexa/ plus Zoloft.
Yes, that list is scary... what the heck do they suggest? Guns and Cash? maybe some ammo?
Jerry, thanks for the commentary; it's exactly what I've been hearing through the grapevine. Never give up.
In this case, I hope the company dilutes a bit more to raise the needed money. Here is another case where a large pharma would be, could be more aggressive in development, to save time and angst. I wish it were partnered. I wish that GNVC could achieve a happy medium between what they think they deserve at the phase IIb/phase III level to what pharma would like to pay for proof of concept. I think they're going to make it, and think TNFerade is a winner. The initial graphs and phase I trials are very encouraging. Also, I don't think they're has ever been a human trial where there has been zero effect.
Head and Neck is difficult because it is a very heterogenous group(extremely so)with rich vascular tumors, quite bloody, with poor survival rates if there is tumor bulk hitting on breathing/swallowing centers.
Actually, mechanistically, I'm most interested in the distant mets group for pancreatic cancer. Is there some distant mechanism of action in TNFerade beyond it's cytogenic mechanism of action as has been hinted in several animal studies. Could injecting a tumor locally improve survival even if there is distant mets? This implies some other mechanism of action. But why? It is all quite interesting for a series of tough-to-treat tumors.
TNFerade is a winning drug. The question remains the suitable design of the needed head/neck, esophagus, and pancreatic ca. I am, however, uncertain as to the timing or needs of the FDA here. To buy the argument that the FDA will simply roll over because "we are dealing with pancreatic cancer" misses the point. I don't trust them(FDA)and could see additional time delays, dilution. But, in the end, more so than Provenge, I think TNFerade will have a roll in a variety of cancer indications.
emeraldcity, I'm in general agreement with your words on Varney and management with one exception. Thankless work? Maybe, but to make 6 figures and to live near a beach in Southern California??? I mean, just how bad can it be!
One possibility I hadn't thought about: with all the baseline variability in the sleep apnea population, it is possibly, I suppose, they might have increased the n=number of patients from 20 to a more robust number. There are very few placebos in this group, so they need a decent baseline. Expanding n=number of patients helps impact this problem.
This would not be unheard of. Consider the Cortex RD trials: I believe they expanded the number of patients. I believe, though, the DMSB asked for more patients in RD.
Thanks Alex, I want to see that....
The political implications of a dead health care process or a simplified, stripped-down one are only to the positive for Obama and the democrats and possibly even negative for the GOP since they, the republicans, will not have the same sense of outrage to face in November, but I'm not sure Obama's "brain trust" sees it that way(time to ditch Rahm and bring in David Gergan, perhaps a Bill Clinton as well to show O how it's done).
Very important only loosely off-topic implication concerning today's election and prospects for Obamacare.
I thought 95 % that something, even watered-down, would pass. Tonight, Webb and E. Bayh appear to be backing down, Webb even going so far as to caution against moving forward with any health care proposal until Brown is seated. Frank, the biggest surprise of all(Barney that is) said something to the effect that perhaps democrats should regroup, see if the republicans can support anything on a more bipartisan basis, clearly implicating that the "ping" option where the house passes the senate bill isn't going anywhere soon.
I think that what might now passed is a watered down version, stripped of the taxes, fees, and regulations, possibly including the individual mandate(I certainly hope so) and reform health care using the following metric:
1) Making it illegal, indeed enforcing prosecutions if needed, the practice of dropping folks for pre-existing conditions. Of course the insurance industry loves the individual mandate, but I think that won't hold up in this pitchfork environment.
2) Allow interstate competition amongst insurance companies.
3) Pilot programs in selected cities to see what the freak works! ( public option, health care IRA's, ect)
4) Drop the cadillac tax on cadillac health care plans, industry, providers, whatever: the folks are taxed enough.
5) Allow the original language on biotech/pharma(which had been agreed to already) to stand.
6) Build more medical schools and nursing schools and SOON, because what the republican bozos and democratic bozos don't seem to realize that we're are graying population is growing more rapidly then the supply of docs and nurses. IRRESPECTIVE of what type of health care system we have, we have a growing shortage of providers.
7. My preference, but more risky politically: allow all kids to have Medicaid until the age of 25(no, I don't think that will cost that much since what they really will use is the catastrophic component mostly, and I believe that dentistry and medical care is a must when young) ((My added point is this is 'doable' without spending 1 trillion dollars. If I had my druthers, I would expand Medicare but this probably will not work fiscally)). I also think Medicaid should provide for dental care: in Arkansas it does not and there are added restrictions against psychiatric care as well.
8. Electronic Medical Records to bring our system to a unified, coherent record-keeping system.
9. Expand fraud protection for Medicare: see 60 minutes reporting for the abuse that occurs for Medical Devices that accounts for perhaps Hundreds of billions of dollars of outright fraud yearly.
1-9 or most of these would be supported by most Americans. Lose the tax angle, simplify it, keep the components that the overwhelming majority of us support.
But this is a Cortex biotech board: not a doc venting group, so the implications of a dead health care process or reformed, simplified one outlined above mean a potentially bullish scenario for biotech and pharma and all of their micro-cap derivations.
I'm not good at judging men on their looks; suffice it to say, Varney looks like a normal joe... or should I say a regular bloke.
I think he's British. Got to love how, how the brits kick are ass in spelling and writing skills... but I digress. I've got a great discs of Churchill's oratory. Stiff upper lip....
Haysaw, why not put on the CEO cap and tell us your vision for what you want? Isn't life short enough by just being negative? Isn't there a bit of Cervantes in anybody who invests in micro-cap in the first place? Is it all drudgery and negativity? Why not get a touch whimsical for once?
I'll admit I seem to lurch from one end of polarity towards Cortex, but you seem firmly latched to the negative end of the emotional tone scale. I guess, haysaw, I just don't get it.
You recite with the skill of a biblical scholar some obscure Dr. Tracy past statement, have memorized all of our foibles and past musings, the history of Stoll, yet apply none of you focus/zen towards the remote possibility of a remotely positive outcome; how come? Hay, let me write you a script for Paxil or I'll buy you a happy lite on amzn.
davey is a real person, a nice guy, who does not work in the biotech industry. He does not deserve this attack. I have found in him honest without an agenda. Sometimes, hay, when someone tells you about the 'real story' it is not meant as hate speech or to deflect inquiry, but, rather, to simply show a bit of respect. There are times in life when we all suffer all types of success and setbacks in a variety of formats. I know davey rather well and I know the real story referenced by neuro. Mate, just show a bit of respect regarding davey.
OT to Cortex now, but not to biotech/pharma.... essentially, Obama screwed the pharma/biotech industry at the last moment after initially saying yes(earlier in the process to gain their support). I have mixed feeling on this. On the one hand, I like this populist move in some ways as I have a birds eye seat to pharma/biotechs' marketing machinations, but it isn't good for research/development, rational for putting millions, hundreds of millions of dollars into innovative research, and lowering the US as best in the world in said field. This is all part of Obama's effort to save last minute dollars to pay off congress in the endless sausage making. (But in terms of attempting to ruin our country, I would expect no less from President Obama) obvious editorial comment from this doc who's gone from highly pro-president to highly disliking his performance. Enough of me, here's the article:
"Drug companies threatening to oppose health bill
Drug firms threatening to end support for health overhaul in biotech drug dispute
ALAN FRAM
AP News
Jan 15, 2010 17:24 EST
The drug industry is threatening to end its support for President Barack Obama's health overhaul effort because of a rift with the administration over protecting brand-name biotech drugs from low-cost generic competitors.
In an e-mail obtained Friday by The Associated Press, the president of the Pharmaceutical Research and Manufacturers of America told the trade group's board members that "we could not support the bill" if the industry is given less than 12 years of competitive protection for the expensive products.
Obama and House Energy and Commerce Committee Chairman Henry Waxman, D-Calif., are leading the drive to shorten that period, which proponents argue would be a boon to consumers.
"Please activate immediately all of your contacts," said the e-mail from Billy Tauzin, the group's president.
The pharmaceutical industry has been a crucial supporter of Obama's health effort, having spent many tens of millions of dollars on advertising and lobbying in support. Drug companies should profit from the millions of additional people who would be able to afford health coverage under the legislation.
The threat comes with White House officials and Democratic congressional leaders nearing an agreement on compromise legislation reshaping the nation's health care system.
With a deal so close, it was unclear whether the partnership between drugmakers and the administration was truly in jeopardy, or if the e-mail represented an effort by the industry to pressure the White House to drop its effort to shorten the period of competitive protection for biotech drugs.
Any compromise bill, though, will face a nail-biting trip through Congress, where Democrats got barely enough support when they pushed initial versions of the bill through the House and Senate. If the drug industry decided to pour money into advertising opposing the legislation, that could give some lawmakers second thoughts about supporting the bill.
Ken Johnson, a senior vice president of PhRMA, declined to comment on the e-mail.
Last June, the industry agreed to actively support Obama's health overhaul in an agreement with the White House and Senate Finance Committee Chairman Max Baucus, D-Mont., to limit the cost to drugmakers to $80 billion over next decade.
But as Democrats craft their compromise health bill, they have begun looking for additional sources of revenue to pay for changes they are making. That has included pressing the drugmakers to contribute an additional $10 billion — another factor that might be part of PhRMA's decision to threaten to withdraw its support.
Biotech drugs, manufactured from live tissue, are a fast-growing share of sales for pharmaceutical companies worldwide and are seen as a pivotal part of that industry's future.
The House and Senate versions of the health legislation give biotech drugs 12 years of protection from generic competitors. Brand name companies say they need that period to recoup their investments in the products, which can be very expensive to develop.
The Obama administration has said seven years would be a reasonable compromise. Some lobbyists have said Waxman was pushing to reduce the 12 years to 10 years or less."
Very well said, Harry. It is indeed hard to find balance in treatment, and, indeed, in life.
On hearing of the Korean financing with Cortex, did Elmer Piros yell out, "Banzai!" I hope he doesn't pull out the Samari sword, kabuki makeup and chase Stoll around the parking lot in Irvine tonight.
"Stoll, you impugn my honor, basta... Stoll, you impugn Rodmanson's honor... Stoll, I must avenge the honor of Rodmanson. Stoll, I will make duck soup out of your hat, coleman too...." just kidding, elmer.
I agree. I think to be fair... management could have negotiated a sell out on the cheap with some type of salary paid for a year-if not more. There goal is becoming more clear: not to sell out the company, but to turn it around. There motives may not be altruistic here, but to transform their options into money: 2-3 dollars a share(or more). Now, one can give critique to management for not going for a buyout(which I favor 50 % of the time), but they're not interested in a quick sell out. The converse is also true: there is no hidden motive I had feared about a sell out on the cheap... at least intentionally.
Now some of the talk I had heard about the end of March for announcing the RD deal(which rumor has it is basically done and agreed to)makes sense. IF they can ink an RD deal with 5 million dollars in upfront payments and a modest development fee for RD, convert some of the low lying warrants into cash, they can come up with the 4-5 million in will take to run a modest ADHD trial for CX1739. The other shot on goal, although a long shot by a drunken midfielder, is the long shot... sleep apnea.
But barring some miracle with apneic patients, the path forward according to management is as follows:
1. RD deal by end of March.
2. Raise money to fund a modest phase IIa ADHD trial and obtain ADHD results in 9 months(I think this trial is being prepared as I type this) and partner CX1739 for ADHD.
The operation 20 bagger: 10 cents to 2 bucks a share is full of risk, but so is life.
If Cortex' wants to reach for the brass ring one more time... I say go for it.
At 10 cents a share, Iggs, what type of deal would 'Iggs' have done? Just curious?
Iggs, I'm no fan of management and have long advocated the sale of the company but if they want to fling a last end zone shot or two... let 'em.
One thing we do not know: the account balance for the CRO that ran the sleep apnea trial. My guess, hunch, is Cortex had to cut cost corners somewhere to even go this far without cash, so they probably have an outstanding debt to either the sleep apnea CRO or some other comparable debt(s) that this will fill.
Minus those debts, it will take a bit of time to arrange a sale as you are no doubt aware of.
As for crapping on the shareholder? I'm puzzled. How is this so horrible? We've been crapped on for so long? that raising three to four months cash on bad terms is worthy of your hostile response? Criminal? Really? Good god man. It was criminal of us not to sell at 5 bucks, who cares now!
It's not over till the Koreans say it's over. Was it over when the Germans bombed Pearl Harbor?
Last theory on the finances and the mystery/magic of the burn rate. They're out of money, but have paid the bills, rent, electricity so they can live off fumes till January ends.
Everything is negotiable. Is the real estate market that fantastic in Irvine? California? Are biotechs salivating out there, waiting for Cortex to get evicted from their HQ?
Last time I checked, aren't biotechs vanishing daily? Isn't Cali the forclosure capital of the country? Or is that Nevada.
I think things have been placed in order of demands and wants. If the rent is a little late, they may be willing to wait a bit more for rent. I know of a small busines here in Arkansas where things are stretched a bit.
Money is a string which can be stretched out a bit more if needed.
One theory of mine... or a possibility is Dr. Stoll whom I believe is independently wealthy, might be making small personal loans to management. If he believes a deal will be inked in a few months, he could be doing it. I know that's a stretch, but I thought I'd throw it out there. I think he is loyal to his fellow officers and may be fighting to right the ship.
Now, I'm not sure if it would be legal to make such a loan without some kind of SEC filing, but we haven't seen many SEC filings recently of any type, so it wouldn't surprise me.
He could be doling out 8-10 K per month to the officers, enough to "get by," even paying Varney's mortgage for a month or two. Stoll is a throw the baseball straight down the middle kind of guy, though, so that might argue against this move, but who knows.
I don't know why I posted that. The whole thing is weird. I don't understand it. Traditional thought processes are not enough. I will admit, the whole thing is starting to smell rotten.
I have many Cortex-related contacts whom I trust. I'd leave it at that.
Interesting, like Dante's circles, just when your think it cannot get more pessimistic for our investment in Cortex, each day's, week's, month's, year's Cortex-related machination surprises on the downside.
Now, the fear is not a bridge financing on horrible terms for the 30-45 day partner to return to the partnering table. No, the fear is they will be unable to raise a dime at any price. I guess the mystery to me here is this: at the time of the special shareholder meeting the 45 day timeline had come and gone. Stoll and Varney simply MUST have considered the partner could be playing games. NOBODY could be so OBTUSE to dismiss this possibility. Why not have just done the freaking financing right after the special shareholder vote, raise the needed money to decide between a deal or buyout.
LOL. It is getting a bit ludicrous. Are the lights still on or has Cortex gone dark? Perhaps the corporate officers are just avatars of a single individual? Dr. G Lynch. Seriously, lets discount all future phone conversations purported to be from Dr. Varney. We need proof of life at this juncture! Will the real Varney please stand up!
There are also unknown unknowns. What do you do when your broke? Call Dad. I believe Dr. Stoll is quite wealthy. Is it so hard to believe he might be making small personal loans to the remaining Cortex brass to keep the team together for a few more months. I know this is unlikely, but not impossible. And no warrants would be required=)
Guessing here, but the scuttle was Cortex was to do a smallish "bridge" financing last week to allow time for the presumably RD deal's ink to settle on paper. The week went by and no financing was had; it is either pending, or something else is afoot? buyout? Or, one could also guess that any financing... bridge or otherwise is difficult. Since Cortex is now OTC with terrible volume, Rodman and Renshaw stock machinations, just how easy would it be for the financial buyer to exit their position? The VC guys did it pretty easily, but we were listed then. So, I guess you could get some type of debt offering based on the worth of the ampakines as collateral, which is about the only thing they have left.
The one interesting aspect here is they have not done said bridge financing and basically this was hinted as a done deal 'last' week. Kind of weird.
Done deal without a closing date is suggests a deal that is not done because the anticipated closing date keeps moving from January to February to March to a deal being inked at the end of the first quarter depending on the minute-by-minute mood of Dr. Varney based on what I'm hearing.
I believe he is negotiating in good faith, but it takes two parties to act in good faith for the deal to get inked.
Another worrisome feature might be a Friday evening 12 midnight pr announcing said financing in the dead of night on a frigid weekend. May we live in interesting times.
Time for plan b sale - of the company.
The worse the terms of the deal, ie. the greater the cash amount raised, pledging all assets of the company as collateral, suggest that Varney is not at all confident on the closing date, or sees the closing date of any said deal as being months and not weeks "out there." So, 'the tell' will be the amount of money raised/terms. By contrast, the less money raised(even on crappy terms)suggests Varney is confident of the end game... in terms of weeks with a small bridge loan.
If Varney is that sure of the deal and the turn-around-thesis of Cortex, one way to address the situation here might be to go to ground, replacing salaries with "paper" new options for a month or two, incentivizing management with a nice payoff when the deal arrives, again signifying confidence in the end game.
A shareholder rights offering would be another vehicle to raise a small amount of cash in a pinch.
But I suppose they are beholden to whatever the plans and machinations of Dr. Moriarty(AKA Rodman and Renshaw) to listen to moi.
If Cortex is so sure a deal can be inked, but first they must do a debt offering where its ampakines are pledged, one might ask why take that risk? Why not sell the company?
On the topic of dirty dealing. Is there a chance that the potential bond issuing firm(Rodman or its ilk) could have some back channel communication with the RD company? In such a scenario, it might be in the interests of Rodman and the RD based company to issue the death blow to current Cortex shareholders.
I think I'd prefer the idea of going to ground, moving the burn rate down to as close to zero as possible, and wait for the deal versus buyout offer.
I guess the obvious retort here using management logic is this:
If there is a predatory deal(and dealing)by the RD partner, then if Cortex raises say 1 million dollars or 2.5 or 73 days(pick your number)of cash life vis-a-vis a short term debt financing, wouldn't the obvious counter move of the predatory dealer to simply saig x amount of days? to pressure Cortex?
If Cortex will aimply raise 500 thousand or a million dollars, then the predatory dealer simply resets the clock for another 30-60 days. I don't see how raising x amount of dollars changes the math here.
ombow, I think and feel strongly, you are on the right track. I think it will be a partnership, but for what indication and the terms of I'm at a loss. From the rumor mill, a pharma deal is by no means dead, ill or sick in the slightest.
This is the second life hypothesis which is argued against by the cash on hand situation and share price.
In this reverse split plan, it would actually be 20 to 1. Here's how it could work: take Cortex roughly 200 million shares outstanding and reverse split them 20 for 1. In this category would be the 100 million shares already used at current time(options, warrants, common ect) and the newly minted 100 million shares not yet used(The ghost of Christmas yet to come). The reverse split process could also raise money and Rodman could profit in some way.
In a way, this is the option that would screw current shareholders out of existence, but at the gain, possibly, to newly minted shareholders and management, although I think this would change the actual ownership and BOD composition to a hybrid: Rodman and Cortex, or some other hideous two-headed hyrda.
I think they would do it, if they could, but who would the investors be? How can it get done without changing control/ownership of the company, representing a 'buy-under' ? In short I don't think a reverse split makes sense at this juncture.
The options going forward would/could be:
1. The slow fade out to 1 cent per share, waiting for a buyout with a lone secretary answering the phone? Perhaps outsourced to a foreign country to save the last dime?
2. 2 is a buyout at premium(a tiny, low premium, or a more sizable one 15 cents to 50 cents or more per share).
3. Cortex gets an RD deal done, or some other type of deal and reinvents herself, followed, possibly, by financing and/or reverse split. This appears unlikely as the pressure Cortex is under financially will only make possible partners only more toughened in their negotiation; actually leading to option 2 as the most likely.