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ELN

Started by David Randolph, July 19, 2005, 09:06:06 AM

Previous topic - Next topic

422fwhp

The only thing that really annoyed me was the fact the Scottrade snubbed my order at $8.30 this morning.

I was unavailable to watch it this morning but I checked the price from a friends house and was excited figuring I'd bought it...BAH!  I check my account and there's my order, still sitting there...  Snubbed again.  Oh, how I wanted to add more!!!

Oh well...we'll still make money...I just won't make as much now!   ;D

shawFund

ELN is in uptrend and this can be seen clearly from its weekly chart:



Even bad comments from analyst last Friday did not bring it down a lot.

Any comments?

422fwhp

Any thoughts on the recent news?  I tried to highlight it as best I could.

laterz...Jody


http://us.rd.yahoo.com/finance/external/wsj/SIG=11vmjrond/*http://online.wsj.com/article/0,,SB112525728800624916,00.html?mod=yahoo_hs&ru=yahoo

Tysabri May Be Linked
To Added Side Effects


By SYLVIA PAGAN WESTPHAL
Staff Reporter of THE WALL STREET JOURNAL
August 28, 2005 3:51 p.m.

The multiple-sclerosis drug Tysabri, which was withdrawn from the market this year, could be linked to new serious side effects, according to an analyst's report.

Through a Freedom of Information request, Steven Harr, of Morgan Stanley, obtained a list of adverse-events reports made to the U.S. Food and Drug Administration related to Tysabri.

Following an analysis of the data, he issued a note Thursday describing adverse-event reports in which a number of Tysabri patients died of rare infections. "We're not trying to put a death knell on Tysabri, but there are signals in there that something's going on. It's important for patients and investors to know," Mr. Harr said in an interview.

A spokesman for Biogen Idec Inc., of Cambridge, Mass., which manufactures the drug along with Elan Corp., of Dublin, dismissed Mr. Harr's report. The spokesman said Biogen and Elan had performed a detailed safety analysis of the drug and found no statistically significant differences between serious adverse events with patients given Tysabri and patients given a placebo in several clinical trials.

"We have an enormous amount of information in our hands," the spokesman said. "The [adverse events] database is a limited tool." Biogen and Elan said this month they hope to get the drug back on the market.

Leonore Gelb, an FDA spokeswoman, said the agency declined to comment on the analyst's report.

Tysabri was taken off the market on Feb. 28 after a patient contracted a rare brain infection called progressive multifocal leukoencephalopathy, or PML. Two other cases of PML subsequently have been confirmed by the drug's manufacturers. Out of those three cases, there are two confirmed deaths. It is suspected that the reason patients get PML is because Tysabri suppresses the immune system.

The analyst's report describes seven non-PML deaths in patients taking Tysabri that "appear to be related to immunosupression." One death was owing to pneumocystis pneumonia, an infection that only patients with severely debilitated immune systems get; another was because of herpes encephalitis, a very rare infection of the central nervous system, and four other deaths were possibly caused by "sepsis," an uncontrolled infection that spreads through the body.

The report mentioned that the FDA database contained "numerous" accounts of serious, nonfatal infections that "suggest again that the toll from Tysabri extends beyond PML."

Despite the possible new side effects, Mr. Harr said Tysabri has a good chance of returning to the market. Its efficacy is "so compelling" in multiple sclerosis that doctors are likely to want to prescribe it for their sickest patients even if the risk for immune problems is higher.

At 4 p.m. Friday in composite trading on the Nasdaq Stock Market, Biogen shares edged up 13 cents to $41.05 each.

goldieboox56

Same old song. I would listen to teh CEO's not anyone else.

oicpecnoc

Goldie,

Respectfully disagree on 2 points.  First, if you buy because of what the ceo says, it is a recipe for disaster imho.  Note enron.  There are some straight shooters out there, but generally they are "like a box of chocalates" to quote Mr.Gump.

Second, the fact that PML deaths only occured when in combo with Avonex really doesn't impress the investing community when someone dies from PML.  As your sell order does not get filled, you can yell at your screen all day that it is only in combo with Avonex that people have died, yet nobody seems to care. 

The drug works, and I pray, believe me I pray they get it figured out, but your stop order might as well not even be there if someone dies, in combo with Avonex or any other drug.
Anyone comfortable with the risk stands to make a killing on the stock, because there is a demand for the drug, I just think there are less risky plays.

JMHO


goldieboox56

I know what I saw. I saw blocks of 100,000 and 200,000 on thursday . It has been climbing this wall of worry for months now.


rpccpa

Dumped this on the pop Thursday...

>:D Pick it up in 7's on MKT correction off New Orleans disaster and WSJ news which will get joe retail investor dumping the stock.  >:D

AustinPowers

Interesting, this stock has managed to hold up very well after 2 attempts by spin master to knock it down.  A few months ago this would have punished the stock.  The timing of these attempts is right at the point where this stock could potentially break out.  Are the bulls in control here or what?

422fwhp

<<are the bulls in control or what?>>

YES, we are.   ;D

rickyrick14

technical breakout in ELN soon!

im seeing a symm triangle on the intraday chart thats tightening up on descending volume.

heres the link.

http://www.thebulltrader.com/eln-technical-breakout/

robt

Just offering my 2-cents-worth. As luck would have it, Biogen Idec (Elan's Tysabri partner) was my largest single holding when the news of PML first broke out. My research at the time had already told me how radically Tysabri changed the quality of life for MS patients who were subject to relapse and furtherance of this devastating degenerative disease, so I held through the worst of it -- including the announcements of a second, and then a third, PML case. I eventually sold all of my Biogen on the rumor, initiated by ELN's CEO, that Tysabri's return in the 4th quarter was assured.

Though I chose not to hold through all of the uncertainty, I remain convinced that Tysabri will return to market, and will be more successful than many financial analysts now believe is possible.

Tysabri is not Vioxx. There is no alternative medication that offers similar relief to MS relapse. There are similar medications in development, but most of these use some form of mechanism that is similar to Tysabri.

MS is a disorder of the anti-immune system, wherein the body's defenses attack a protein sheath that coats the nervous system; this sheath is necessary for proper function.

Tysabri, and other new approaches to MS, work via moderation of the anti-immune system.

Most other medications that work in this way moderate the entire anti-immune system, whereas Tysabri is more "targeted" -- it blocks the immune system's disease-fighting T cells from migrating to the brain. While this greatly diminishes the likelihood of an MS relapse, it obviously leaves the patient more vulnerable to brain infection, such as PML (Progressive Multifocal Leukoencephalopathy).

PML is caused by a virus called "the JC virus" which is present in some 60 to 80 percent of adults, and is usually acquired around the age of 14; we generally do not sicken when it is acquired because antibodies are quickly generated, which keep it in check, though it remains latent in the kidneys and possibly the nervous system.

PML was an extremely rare disease prior to the AIDS epidemic. It remains extremely rare outside of the AIDS-infected. As the result of AIDS research, recent years have brought considerable progress to the detection and diagnosis of activity by the JC Virus, and its progress toward PML.

There is no treatment for PML; however, past research on PML indicates that removing the environmental factors that cause the activation of the JC virus will often cause PML to go into remission. It could well be that early detection of JC Virus activity, and cessation of Tysabri treatment is all that is needed to prevent further PML cases. Full-blown PNL is usually preceded by the appearance of detectable brain lesions. Since MS also can produce similar lesions, these precursors were not detected by researchers during the trials, and all three reported cases of PML were quite severe before they were detected.

The fact that all three PML cases involved other immuno-suppressant drugs (Avonex in two instances, and multiple regimens in another) muddies the water; much further research will be needed to determine whether or not tysabri on its own can result in PML infection.

My feeling is that the threat of PML can be moderated, or even eliminated, and that it is possible that Tysabri monotherapy will eventually be shown to be much safer than the combination therapies to which these patients were subject.

Even if the PML threat cannot be moderated, some 3,500 patients have been on the drug in the course of trials, resulting in three cases of PML, and one of these three is in recovery.

If Tysabri were just another painkiller, or any other drug with reasonable alternatives available, I would have no hope for it. As things stand, I am very confident that Tysabri will help a great many MS patients live fuller and happier lives, at least until an even better treatment is released.

I have not, as yet, joined David with a long position in ELN. Given my experience with Biogen, you may understand I would like further confirmation of an uptrend.

However, I do strongly feel that those willing to suffer the ups and downs of this unsettled issue will eventually stand in triumph.

Lots of interesting info here:

http://www.thisisms.com/modules.php?name=News&new_topic=56

If you must smite, post why so I can improve myself.

AustinPowers

  :D Nice call Ricky.  Eln lookin god today!

goldieboox56

The best is yet to come. Strong buy.

goldieboox56

DJ ) 09/01 01:51AM DJ Biogen Idec To Seek Stronger Warning Label For MS Drug
CAMBRIDGE, Mass. (AP)--Biogen Idec Inc. will ask federal regulators to allow
it to resume sales of a multiple sclerosis drug linked to a brain disease with
additional warning labels, the company's CEO said in an interview.
James Mullen said Wednesday that Biogen Idec will likely recommend that
Tysabri include warnings about three cases of an often-fatal brain disease
that were confirmed after clinical trials of the drug, which was withdrawn
from the market Feb. 28 despite hopes that it would become an important new
tool in treating MS.
Mullen said the revised label that the company will propose to the U.S. Food
and Drug Administration also will warn about risks for patients who have weak
immune systems and therefore could be more susceptible to contracting the
disease, called progressive multifocal leukoencephalopathy, or PML.
However, Mullen said the label language his company will suggest to FDA when
it seeks permission to resume marketing Tysabri will acknowledge that
scientists don't yet understand precisely how the bioengineered drug put the
three patients who contracted PML at risk of contracting the rare disease. Two
of those patients died.
"I think it's important for us to not overstate what we know," Mullen,
Biogen Idec's chief executive and president, said in an interview with The
Associated Press at the company's Cambridge headquarters. "We want to be
concrete about what we know and what we don't know."
Mullen said Biogen Idec and its Irish partner on Tysabri, Elan Corp., plan
to submit findings from their review of the drug's safety to the FDA by the
end of September.
The companies had previously said the report would be submitted sometime in
the fall so the FDA could review whether Tysabri can safely return to the
market. Some industry analysts have said strong warnings on Tysabri's label
could ruin the drug's chances of becoming a commercial success.
Mullen said it is "highly unlikely" the FDA will complete its own review by
year's end, but he said the regulators are "interested in a thorough but
expeditious review of determining whether this can brought back to the market
in the near future or not."
FDA spokeswoman Lenore Gelb declined to comment Wednesday.
Biogen Idec and Elan said Aug. 9 that more than 2,000 patients with multiple
sclerosis who took Tysabri in clinical trials had been screened for PML as
part of the companies' safety review, but no new cases were found.
The companies are close to finishing a similar review of about 1,500 people
who took Tysabri in clinical trials to test its effectiveness in treating
Crohn's disease and rheumatoid arthritis.
After reviewing one year of data from planned two-year trials, federal
regulators in November approved Tysabri for sale to the 350,000 American
sufferers of MS, a debilitating and incurable disease in which the body's
immune system turns rebellious, attacking, inflaming and damaging its own
nerve tissue.
The drug was withdrawn about three months after its approval, causing Biogen
shares to plunge more than 42% the day of the announcement while Elan's stock
fell 70%.
"We hope there is a pathway back to the market," Mullen said. "We think that
unless we see some new surprises, that the risk-benefit profile for this
product certainly warrants it being used for MS.
"We've got probably hundreds of letters from patients saying, 'Tysabri
changed my life. I've got no other options. I'll sign whatever waiver I need
to get access to this product."'