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PGS:
My problem was exactly with what you refer to.
Do you have by any chance the post number, so I can
recall my argument to refute yours?
I might figure out at the end that my argument was faulty,
and retract my statement, but I am not there yet.
Dunno
The problem with PGS argument was not its complexity, but that it was faulty. Of course we know now that it does not work, but I would not mind seeing any logical argument from data before today to indicate that.
YMI has done a lot of extensive work around tesmilifene lately.
They claimed that they were preparing patent filings for YMI.
Also the CEO bought 50000 shares at $3.00.
Since they had no intention to raise money before the results came out the further Tesm expenses and CEO purchase would not make sense.
So please tell me something more to convince me that I am not merely unlucky, but I dumb sucker.
PGS,
It is kind of funny for me to make a statement about it now.
Your conclusion was absolutely right. On the other hand your argument you used was wrong.
Yes. I lost a ..load of money, but I am smart
Ithink that this is the recap of the Cramer video:
http://www.thestreet.com/_tscs/funds/realmoneyradiowrap/10329451.html
My guess is 87.
And I made the same mistake too.
I think previous guesses ignored the fact that in the last couple month we have already got to 60.
2007 will be the year when development stage biotech will become hot again. Bubble will develop. Complete idiots will flock to this board posting all days.
Can you see the first sign?
This is my 5th. post today, and I still have not replied to john about AEZS. (Short reply: I Dunno, but I will go more detail to say the same.)
Analysis: Alexion's pexelizumab fails ( Medicure pump from Dunno)
By STEVE MITCHELL
UPI Senior Medical Correspondent
http://www.upi.com/HealthBusiness/view.php?StoryID=20070102-051840-6113r
WASHINGTON, Jan. 2 (UPI) -- Alexion appears to have killed the development of pexelizumab due to disappointing phase 3 results indicating the heart-attack drug is no better than placebo.
The impact of the news, which appears in the Jan. 3 issue of the Journal of the American Medical Association, may be slight because the results have previously been released by Alexion, which had been developing pexelizumab in collaboration with Proctor & Gamble.
Experts say that although this is the end of pexelizumab, the concept of using an anti-inflammatory to treat a specific kind of heart attack known as acute ST-elevation myocardial infarction, or STEMI, is still very much alive.
"I think it does mean an end for this drug, but not an end for the concept," Paul Armstrong of the University of Alberta and lead investigator of the trial told United Press International.
"The flip side of these things is that it opens up new opportunities for contenders to the throne," Armstrong added. "And this area for inflammation as it relates to how big heart attacks are and what are the consequences is still an untapped frontier."
One possible contender, he said, is an agent called MC-1 that is being developed by Medicure. The drug is currently in a trial involving patients with coronary bypass, and Armstrong is serving as a scientific consultant to the company.
In the pexelizumab study, which was known as the APEX AMI trial and involved 5,745 STEMI patients, Armstrong and colleagues evaluated infusion of the drug in conjunction with reperfusion procedures, such as angioplasty or stent placement.
No difference was detected in the rate of death at 30 or 90 days between the pexelizumab group and the placebo group. Both groups had a low death rate (3.92 percent in the placebo arm at 30 days versus 4.06 percent in the pexelizumab group). Rates of cardiac shock and heart failure were also similar between the two groups.
Although the pexelizumab results were disappointing, "the good news is that the mortality was the lowest ever reported in a trial of this magnitude," Armstrong said. This means that if patients are rapidly treated with currently available therapies, they may fare better than previously thought.
However, there's still a substantial unmet need in this setting, so Armstrong's group is working on developing strategies for getting treatments to patients faster. This includes possibly teaching paramedics how to recognize this condition, using new technology to transmit electrocardiograms from the field so a physician at a remote site can help make the diagnosis.
This could allow clotbusters, such as fibrinolytics, tenectaplase and tPA, to be delivered earlier, which may avoid heart-muscle damage altogether, Armstrong said.
John Eikelboom of McMaster University in Hamilton, Ontario, Canada, who co-authored an editorial in JAMA, told UPI he agreed that the concept of using anti-inflammatories was still a potentially viable strategy.
"The trial results probably mean the end of pexelizumab," Eikelboom said. "It would be difficult for it to find a niche in practice," he said.
However, Eikelboom added, "I don't think the concept can now be dismissed." There are still questions that remain unanswered, such as whether pexelizumab acted on the right target and whether there might be more effective ways of developing a potential drug.
Other anti-inflammatories in development that may have potential include an inhibitor of C-reactive protein and drugs that target white blood cells, Eikelboom said.
Stephen Squinto, Alexion's executive vice president and head of research, told UPI pexelizumab was essentially a dead program.
"We don't think we intended to take this drug forward," Squinto said. He noted that the phase 3 results have been publicly disclosed two previous times, the most recent being at the American Heart Association meeting in November.
Alexion will now focus its attention on Soliris, a potential treatment for a rare, life-threatening blood disease called paroxysmal nocturnal hemoglobinuria. The company has filed for approval in both the United States and Europe and hopes to launch in 2007, Squinto said.
Cristrader,
We cross posted. My point hidden deeply in my previous post is
that there are much better potential way to finance the rest of the pipeline.
mcu medicure
Drbio,
The important issue you raise is that Medicaure has a rich pipeline. Currently the company has enough money to complete MC-1 for CABG, but no money to move forward the rest of the pipeline.
If they find the right way to finance those, they will.
There are many ways to do that. They can do another secondary,
and if the share price increases substantially I am sure they will do that. They can partner MC-4232.
They will need to that anyway at some point. A blood pressure medication need a big pharma for partnering. They can They can partner MC-1 for ROW, etc.
If I were even dumber than I am I would point out that your arguments do not support your belief of partnering MC-1 in USA.
But since I am way overweight in the stock, and has no intention to increase that even at this ridiculous price, my interest is the stock price increase.
Belief tht Medicure soon partner MC-1 potentialy increase
the share price. Although I believe that the current share price also indicates that nobody really believes that anymore.
So I have no intention to dissuade anybody about believing that partnering is imminent. Of course I
Dunno
anything anyway.
On YMI
Aeroleaf final phase II results were indicated for end of January or February in the last CC.
Tesmilifene third interim look also expected by this time frame.
Dew,
For warning signs you listed trials in third world countries.
That applies to Tesmilifene. Can you give specific reason why I this canbe a problem? Obviously it is very cheap to do it that way. And there must be some reason why not evreybody does it that way.
But I do not understand what are the concrete problems.
Enlightment is appreciated. Tia.
---
Of course the best way to minimize the risk is to have a drug invented in third wrorld country like Nimotuzimab of YMI.
The Cubans have retained their rights to the third world, and partnered with YMI for the advanced countries.
Now Nimo is approved in Cuba, India, China, etc. and there are extensive human data for all imaginable indication.
YMI knows everything about how the drug works, and they do not need animal models, and theory to decide which indications to go after, using what cotreatments, etc.
Partnering and MCU
It might be an opportunity and not a problem at this point.
Its lead candidate is in Phase III with an SPA and fast track.
The SPA requires success in a 3000 patient 2 arm trial in an endpoint, where MC-1 was statistically significantly better already in a 900 patient 3 arm trial.
There should not be any problem with speed of enrollment.
The phase II enrolled pretty fast and this time there is even less competition if any for patients, and much more data that MC-1 is very safe, and highly beneficial.
The risks mentioned by Dew and David do not seem to apply as
Friesen has extensive experience to get drugs through the FDA.
He invested his own money to start the company, and not overly generous to give options to himself.
The company now has sufficient money to complete trial and approval and market the drug.
And most important:
MCU does not need marketing partner in the USA.
MC-2 will be very easy to market for CABG. Target physicians are cardiac surgeon, do not need large sales force, moreover MCU alrady has a sales force for Aggrastat to this market.
Moreover upon approval it will be competition free standard of care not requiring an overly sophisticated sales organization.
The tradeoff between some dilution vs. losing most of the revenue to the partner was probably the right one this time.
(Of course when I invested initially I hoped for quick partnering and profit. That did not happen, But the risk/reward prospect is a heck of lot better now.)
A standard investor mistake is to sell winners and keep losers.
I have sinned like that in the past myself occasionally.
It is certainly a very wise rule to reevaluate 10% losers, to prevent that standard error.
I think I would have sold almost all positions of mine in the past. My biggest gain ever was in a stock that dropped 80% after I bought it. My biggest mistake was to liquidate it way too soon.
(AKAM).
Invidentally both of us had medicure. You are out.
I feel that the risk/reward is now even much better now than originally invested. You on the other hand sold and bought RPRX, and you had to suffer the consequences. I have pity for you.
Dunno
Idiotism on AEZS trade.
Some people have not noticed that AEZS trades today after distribution. Too bad I cannot short stocks under $5.
Thanks John for your reply.
John, RPRX's proellex competes with AEZS's Cetrorelix, that completed a seven Phase II program in endometriosis.
What is your take on it?
Pump: I am long in AEZS. It has a huge pipeline that comes pretty much free, as its approved medications, cash, its share of Atrium (ATB.TO itself a very undervalued nutritional company about to be distributed to shareholders) and royalty revenues from already approved drugs essentially cover the current share price.
Dunno
Rod,
Thank you for illustrating my point.
Do not worry, I have no intention to
further disrespect your support group.
I ma sure you will get healing and solace here.
Not money, because that board is not about that.
I hope some others started to think about
the questionable usefulness of board where only
faithful believers, and talented inquisitors are
allowed to post.
Bye.
I am confused about your comparison of MCU and ALXN result.
You seem compare of MC-1's failure with the peak CK-MB greater than or equal to 50ng/ml measure to pexelizumab's failure with the 100ng/ml measure.
MC-1 was very successful with the 100ng/ml.
John, Merch was actually quite successful with Aggrastat in the USA with about $90 mil/year sales 6 years ago. At that time they sold the USA marketing rights, and that is when the failure came.
Merck still markets Aggrastat in Europe where it is the market leader.
Now Why did they sold the USA rights? I Dunno.
MCU: The reason of omission of IP on investor day was probably because they
had outside medical contributors talk about the science.
In the usual investor conferences the CEO states that they have broad use, method and combination use patent protection in case of MC-1 it is good to some late 10th.
Their discovery program is mostly to modify and improve P-5-P.
For these compounds they have composition of matter patents as well. These drugs are still in preclinical stage.
Randy,
The amount of shares look much order of magnitude higher than what any of these guys would get for compensation. I believe these are real share sales to insiders.
Dunno
Based on this logic MCU should get twice as much.
They work with B6 coenzyme Pyridoxal-5-phosphate.
They target only acute and chronic heart problems, cholesterol, high blood pressure and diabetes. They also said from the beginning that they micmic KOSP's business plan.
I think the double is a modest goal.
Although they claimed making an error in one of their design, that was not their real problem. Their strategy was to push drugs extremely fast into phase III with either no phase II, or very questionable phase II results. After thir first phase III trial completely failed they extensively celebrated its success.
This strategy was very successful, becuase they managed to raise lot of cash for basically nothing in the pipeline, and finally managed to partner their third drug rushed to phase III to King with a $150 million downpayment.
Their financial success was obviously achieved without much development success. Their first two phase III drugs are dead,
and I do not have high expectations for the third drug either.
By the way it is pretty amazing that with very obvious fraud they are rich and happy and nobody sues them. I guess fraud is OK, as long as you are successful.
I do not know. And i am sticking to that answer!!!
Abbott to buy Kos, become HDL-cholesterol leader
This interesting for cobalis because KOSP has a very similar business. It develop and markets a vitamin B (niacin) as drug.
If Cobais is successful with prehistin, it can continue like Kosp for other indication and combination drugs combining B12with older drugs to extend the patnet like of those drugs like KOSP.
Reuters
Abbott to buy Kos, become HDL-cholesterol leader
Monday November 6, 12:13 pm ET
By Ransdell Pierson and Lewis Krauskopf
NEW YORK (Reuters) - Abbott Laboratories Inc. (NYSE:ABT - News) said on Monday it will acquire Kos Pharmaceuticals Inc. (NASDAQ:KOSP - News) in a $3.7 billion deal that would make it the leader in the hot field of drugs to boost "good" HDL cholesterol.
Abbott, based in suburban Chicago, said it would pay Kos shareholders $78 per share in cash, marking a 56 percent premium over Kos' closing share price of $50.09 on Friday. Abbott said the deal will cost $3.7 billion after it receives Kos' cash holdings of $400 million.
Kos' main products -- Niaspan and Advicor -- incorporate prescription forms of the nutrient niacin, which boosts HDL. Sales of the products have surged, pushing up Kos' share price, amid increasing evidence that low levels of heart-protective HDL may be a bigger cause of heart disease than high levels of artery-clogging "bad" LDL cholesterol.
Other types of Kos products in development would be icing on the cake for Abbott, including an asthma drug in late-stage trials and a form of inhaled insulin now in mid-stage studies.
"Inhaled insulin would be important because of our growing diabetes business," Abbott spokeswoman Melissa Brotz said, referring to Abbott sales of $1.1 billion in 2005 from its line of diabetes diagnostic products -- including blood glucose strips and meters.
Abbott said it expects the deal to hurt earnings per share in 2007 by 2 cents to 3 cents, and be neutral to positive for earnings in 2008.
"Abbott shareholders over the long haul will be pleasantly pleased in what they've acquired through the Kos deal," predicted Robert Hazlett, an analyst with BMO Capital Markets.
The transaction is the latest in a flood of big acquisitions in the pharmaceuticals sector as drug companies, struggling to develop new products of their own, compete to acquire them from others, typically biotechnology companies.
And analysts have been surprised at the premiums being paid -- some think Abbott may be paying too much too.
"I'm a little surprised at the premium," said Bruce Cranna, an analyst at Leerink Swann & Co. "This is a space Abbott has expressed interest in, but I'm not quite sure that they have enough critical mass in the primary-care physician marketplace versus the specialist market."
BMO's Hazlett said Niaspan and Advicor should bring Kos combined sales of $650 million this year, but he predicted annual sales of the two drugs and improved versions of them could eventually top $2 billion when bolstered by Abbott's larger sales force and marketing budget.
The deal underscores Abbott's determination to become a major player in the cardiovascular market. It already sells the $1 billion-a-year Tricor, which cuts levels of blood fats called triglycerides, and is developing a pill that combines Tricor with AstraZeneca's (London:AZN.L - News) Crestor -- one of the most potent drugs against LDL cholesterol.
Moreover, Abbott recently launched in Europe its drug-coated Xience stent, which has proven to be more effective in clinical tests than Boston Scientific's (NYSE:BSX - News)market-leading Taxus device to prop open coronary arteries.
Kos, meanwhile, is conducting late-stage trials of a new product called Simcor that combines Niaspan and a generic version of Merck & Co.'s (NYSE:MRK - News) LDL-lowering Zocor.
Kos has been bracing for a marketing battle with Merck, which is developing its own niacin-based products to boost HDL. Merck suffered a setback in September when it announced it would delay seeking approval for a triple-combination product that combines niacin, Zocor and a third ingredient designed to block the facial flushing that is often a side effect of niacin.
Pfizer Inc. (NYSE:PFE - News) is betting heavily on HDL as well, spending $800 million on ongoing late-stage trials of a drug called torcetrapib that could reach drugstores by 2011, if U.S. regulators approve it despite its tendency to raise blood pressure in clinical trials.
Shares of Kos jumped $26.90, or 54 percent, to a 52-week high of $76.99 in heavy morning trade on the Nasdaq. Abbott shares slipped 16 cents to $47.48 on the New York Stock Exchange.
Shareholders owning a majority of the shares of Kos' common stock have agreed to tender their shares or have their shares acquired by Abbott, the companies said.
(Additional reporting by Toni Clarke)
Yes. I have written once and I recieved a very extensive
and mostly convincing reply defending and clarifiing the analyst opinion.
It might have helped that my letter was partially written in some weird language, that the analyst recognized as his mother tongue.
Why to love YMI?
I do agree most of what you say, but nonetheless I still believe that YMI is the greatest investment of all.
Nimo is the dream drug for development, and now it has received the first step towards import permission to the Unted States.
It is a dream, because the drug had been extensively used in Cuba and other 3rd. world countries. They know exactly what the drug does and does not do. It is trivial task to select the right indications for trial, to design including appropriate powering, etc. Moreoever it is by all indication simply a much better version of erbitux, a big seller.
---
Incidentally that is also a paradigm the FDA will have to deal with in its modernization. FDA does not allow new drugs to be tested on everything and on everybody at third world countries before submitting trial IND-s. But what can they do when the invention happens in the thirld world?
In the future a lot fo invention will come from China and India, etc. How will they deal with that?
---------------------------------------------------
Tesmilifene: I agree that whatever they know about the initial results it is much worse than what they hoped for based on the earlier Canadian trial. And pretty much I agree with everything what you wrote. And I am not happy with their ethics either.
There is one huge difference between the current trial compared to the previous one. The FDA in its eagerness to help this drug to suceed fast and cheap allowed the trial to run in East European and Third World Countries. In these countries
living standard is much lower, and patients die even with the same oncologic treatment at a much earlier stage of disease, for example infections, etc. As a consequence patients from both group died at the stage where tesmilifene did not make any difference hurting tremendously the hazard ratio advantage of tesm. (The CEO stated earlier that he expected that events would be reached later than exrapolation from the Canadian trial would suggest. Naturally exactly the opposite happened.)
On the other hand at the current stage of the trial the tesm advantage already should be ovewhelming, so for the remainder of the trial the hazard ratio, should follow the previous trial. That should mean that by the fourth look the trial likely stops with success.
If not, then I am delusional, and win less money than I hope. Nimo in itself worth a multiple of the current stock price.
Even if Aeroleaf were the best clinically I would be skeptical of commercial success in the USA. It gives too much control of patients to narcotics. There is too much paranoia about that here.
For comparison to the best of my knowledge in Europe terminal cancer patients typically get unlimited opioids and practically encouraged to overdose most often without even mentioning that this is the game.
Well. This should serve as a lesson that some esteemed poster buy Reuters' spin, hook, line.
I would say let us not bury aeroleaf yet. Let us wait
for the full result.
We can make extrapolate the japanese deal for Nimo that indicates that that drug conservatively should be worth much more than the company's current valuation. So tesmilifene and
aeroleaf are just bonus.
Strange market action:
The stock price of YMI went down immediately before the announcement of the Dept. of Treasury import approval Nimo,
and went up before the bad news of aeroleaf today.
Highly unusual. BRD David or anybody else can explain?
Thanks,
Dunno
Reuters was not quite accurate.
"did not provied significant difference" reuters
"however the difference between the treatment arm and placebo arm had not yet achieved the significance level predefined in the study protocol ..." - YMI.
It is not the same.
Sample size is small. It is touch up job of already loaded patients, as rjf pointed out. Placebo effect is huge in pain.
This is not the ned of the drug, but it is not too great either.
It is not necessarily bad for YMI.
Fentora claims pain relief within 15 minutes.
Ymi claims aeroleaf relieves pain within seconds.
Fentora's approval validates the fast action for breakthrough pain as a valid goal, and aeroleaf is claimed to be far superior.
How?
Should not we get together and offer financing.
My understanding that insiders are putting up loans to finance the trial. In the past they converted loans to shares.
For conspiracy theory how about if insiders do not make serious effort to find financing and they might try to dilute the shares seriously at low price.
If we make some sort of offer that could seriously decrease the chance of that.
(I have no clue about either the ethical standard or financial ability of insiders at the Cobalis, but I have seen similar things at other companies.)
Any opinion?
Shall we just send the company a feeler offering to put together financing ourselves as small investors of the company?
Dunno
No word on finances in the announcement.
Very encouraging decelopment. NoIt raises the question how they
are financing the trials, as the company as far as we know have no
moeny.
Anybody has any clue?
Of course. With a crossover trial, when the patient gets at random time period the drug at vatious doses, and occasionally placebo.
It can be double blond as well.
Once you bring back my censonred post I will answer.
Until then you are on ignore.
Parentgratae,
The way I see it:
Both the California and Virginia court involved are Federal District Courts with exactly the same jurisdiction. Federal Jurisdiction was not disputed by either party. It came inter alia from diversity of citizenship. The judge in California examined whether California had personal jusrisdiction in order to make decision about the proper federal venue, and not to decide its own jurisdiction, which is again Federal and not California state jurisdiction.
I believe that the court refused to leave permit to amend was the venue issue. Venue is often an issue in state, federal, and even in international cases.
For others who seemed to argue with me, I have no idea about their point. I think I made it clear that Tercica's claim is obviously very weak and even if they win the damages would be less than the legal fees. Their likely purpose is to deter INSM from comparative advertizing as abpalotta wrote in YMB.
(I kind of understand why he does not write here)
In the same time I think that INSM's chance to win legal fees in California is also very weak. The judge issued a 29 page document to support her rulings without naming a single infraction of Tercica. That does not look like a frivolous case. Of course INSM also knows that. The purpose again not to win this, but to limit Tercica's future litigous activities. It might work.
I appreciate your apology and I apologize myself. It seems to be the spirit of the board.
Of course I can be of wrong in some of the issues. Even lawyers are often wrong. And I am not a lawyer, I am just under Supreme Court restraining order not to act like one.
Dunno
If your stock goes up you are a genius.
If your stock goes down, it is market manipulation.
Is not that a little bit simplistic?
New PR from Cobalis: Detailed plan about Phase III trials. No word on financing.
Beachgal: Thank you for the compliment.
OT: Beachgal, Hmm. I should learn tolerance from you towards these paranoid rabid defenders. Needless to say it is not my first experience like that either. -Dunno
One more thing:
Had the judge found that INSMED did not violate the Lanham act,
Tercica would not have had the right to file it again in Virginia. Their only choice would have been to appeal, which of course they still can do.
In this case Tercica had the right to resubmit the claim in Virginia stating now finally that Jones was dead. (INSMED made false statements to customers specifically Endos.)
It is not a very stong case, and their priamary purpose is not even to win.
Parentsgratae,
I think you should reread and try to comprehend abhrpalota's reply to you in YMB.
Federal jurisfiction was never an issue. The issue was venue (i.e. which Federal court is appropriate.) Az Insmed had not done business at California at that time INSMED had the right to object the venue. Had they not objected and the judge had not dismissed the case on another grand the action could have proceeded with perfect juisdiction.
Since May 24 Insmed conduct business in California, anybody can sue them basically at any court for allegation after May 24.
The judge never found that Lanham act was not violated, merely that the statements Tercica made do not support it even if found true. And that is a major difference. To give you a simple analogon.
If Smith is sued for murdering Jones, but the complaint does not mention that Jones is actually dead, then the complaint will be thrown out. This happened here. In this case Tercica came back and second complaint asserted that Smith shot Jones 80 times, and Jones's body looked really bad, but they failed to say again that Jones was dead.
This by no means say that Smith did not murder Jones. Merely that the complaint does not support claim. The dismissal of course does not express opinion about the truth of whether Smith shot Jones or even that these people exist. It merely states that even if everything is true that they allege that would not support the murder charge.
To translate back to the real case Tercica made claims that INSMED made false statements to investors, but it did not make claims about false statements to customers.
It is probably safer if you give your not too deep legal expertize a rest, and not try to explain the case.
If others have questions just ask.
30,000 sahres are a lot for cobalis.
OT: BTW Beachgal, my experiences in insmed I-hub board are rather similar to yours.
dunno