I wonder if any gamblers noticed my post 334 on the GMC thread yesterday.
It looks as though bottom fishing can sometimes pay off.

It all becomes clear now forbes today said that its reasearch from the neurology community indicated 59% of doctors would be unwilling to prescribe Tysabri except as a therepy of last choice given the potential for the PML side effect. Projecting only 10% of MS patients would be given the drug. Fair enough, but given the amazing benefits to be had from the drug, and the fact it is twice as effective as any other therepy, I think the paying american ms community would take their chances, given the alternative of a slow degeneration of brain functions. Plus PML was only detected in two MS patients who were on a dual therepy ( Tysabri taken in conjunction with other immunosuppresents ) and never when tysabri was being used as a monotherepy. So instead of selling tomorrow morning I shall be sticking with ELA and waiting for the FDA decision which is only a few days away (they meet on the 7th or 8th of March and report later in the month) I may ironically enough top up as the price may drop further, and no I have not lost all my sanity, I simply believe in the prouct and have 3+ years experience of it.

Just wish I had more experience of the crazy world of stock market investment, then perhaps I would have seen this coming. Oh the pharma world is a thrilling ride! Then again I could simply bet on the dogs!

and so we come down to it, a year of waiting is nearly over, tuesday and wednesday see the FDA in conference to review Tysabri. They will decide the outcome of a drug that holds much potential, and some think also is the future of elan in the short term. A percentage of the medical community seem to be indicating they expect to see the return of Tysabri to the market but with restrictions over its use.

Market analysts see this company and its short term future as so dependenent on the drugs re-emergence that last week saw the stocks value fall several percent with various stories circulating about the likelyhood of the FDA saying yes or no to relisencing of tysabri.

Obviously I have a personal interest in its future and hope that when, as is expected, Elan reports on its future through its webcast from the Cowan & Co health care conference, the news is good. I expect the FDA will give a green light to the relaunch of the drug, without as many restrictions as might be expected. I will tell you why, because its is at least 60% more effective than any other therepy currently available for MS. It fullfills a huge unmet clinical need and as such will be given the go ahead.

also the unfortunate illness PML was only reported in those who took Tysabri in conjunction with other immunosuppresscents, so I predict as a monotherepy it will be relicensed with the warning not to be used with other immuno therepys. So the sales could still be much more significant than some pesimists anticipate. As a monotherepy it is a great advance on anything currently available and I think the MS community will be clamouring for it to be made available, hence sales will be significant. The problem is there are to many underinformed analysts and writers who comment without fully researching their facts, hence the rollercoaster ride this share price has been enduring over the past few weeks.

there is also hope for the future without even Tysabri, Elans current research has in the phase three clinical trial their Altsheimers drug, inspiringly named, AAB 001 which if you speak to any neurologist tehy will tell you of its massive potential and that it is the first drug of its kind to be trialed and there is no other therepy which has any effect on this condition. so when and if it is approved it will be on its own in the field as an effective therepy against this condition, and that really does mean billions and billions in sales....in the mean time roll on wednesday....

Thanks for that Crippy. I'm holding on, and awaiting the outcome this week, I think it's more likely to be positive than negative.

Thats the spirit Frampton! Found an interseting website extoling the virtues of tysabri:

http://www.mspatientsforchoice.org/

So as you can see its not just me ranting on about how great Tysabri is :)

Noted a large end of day trade on the london market couldnt find out if it was a buy or a sell sorry. about 191,000 in total!

Interesting website Crippy.Last chance to buy or sell, only a few more hours before we are locked in awaiting news....

topped up a bit yesterday @ 10.63 euros seems to be a last rush of buys today and hence price up to 11.47 euros as i write. now as you say frampton its a waiting game....

some latest news from bloomberg....posted 40 mins ago just about sums up the first day in the FDA review....

Biogen, Elan Propose Measures to Control Tysabri Risk (Update4)
March 7 (Bloomberg) -- Biogen Idec Inc. and Elan Corp., seeking to resume U.S. sales of their multiple sclerosis drug Tysabri, proposed to restrict the treatment's use to reduce the risk patients will contract a rare, fatal brain disease.

The drugmakers told a panel of advisers to the Food and Drug Administration that they will monitor Tysabri's use by having the drug administered only in registered centers. Patients would be required to sign a form confirming they understand Tysabri's risks, and doctors would be instructed to suspend treatment if patients show signs of developing the brain infection.

The companies, whose shares were halted today as they have been reacting to Tysabri news for months, told the panel the drug should be made available because it is better than existing therapies for the neurological disease that affects 400,000 Americans. The committee must weigh people's rights to an effective treatment that has severe side effects against the FDA's responsibility to protect the public.

``Although data is limited, we seek to limit death and disability if PML occurs,'' said Carmen Bozic, Biogen's vice president for drug safety and risk management, at a meeting in Gaithersburg, Maryland.

The committee of doctors and scientists heard demands from patients today requesting the drug and will vote tomorrow on whether the FDA should allow Tysabri sales to resume. If the drug gets a favorable review and returns to the market, it will be only the second time a company has been allowed to bring a back a suspended medicine.

FDA, Companies Collaborate

GlaxoSmithKline Plc's Lotronex, the first drug for irritable bowel syndrome, was resurrected in June 2002 after spending 19 months off the market when it was linked to patient deaths. Lotronex won back a limited approval at a lower dose and the FDA set up restrictions for its use.

The FDA has been working daily with Biogen and Elan to craft a monitoring plan that would help control Tysabri's risks, agency officials said today in a conference call. The plan, which would include distribution controls, restrictions on prescribing and patient tracking, would be aimed at educating patients and limiting use to those who are aware of the potential dangers.

``We've had ongoing discussions with the company in an attempt to resolve some issues so that, pending tomorrow's committee recommendation, we can move forward as fast as possible,'' said Russell Katz, director of the FDA's division of neurology drug products, in a press conference. The committee will be asked to weigh in on some of the restrictions, he said.

Shares React

Tysabri was suspended a year ago after it was linked to two fatal cases of progressive multifocal leukoencephalopathy, a brain infection known as PML that is caused by a virus. Study results suggested Tysabri is twice as effective as other MS treatments. At the same time, people taking it face a 1 in 1,000 risk of PML, according to the National Institutes of Health.

Shares of Cambridge, Massachusetts-based Biogen rose 1 cent to $45.51 yesterday in Nasdaq Stock Market composite trading. Dublin-based Elan gained 70 cents, or 6.6 percent, to 11.30 euros before the trading suspension at 1:03 p.m. in Dublin. Both stocks fell last week after researchers said Tysabri can deplete immune- system cells as much as HIV.

On Feb. 28, 2005, the day the drug was suspended, the companies' shares plummeted, wiping out $17.8 billion in combined market value. Elan has gained almost two-thirds and Biogen rose as much as a third since October as no new cases of PML surfaced and management laid plans to press for a resumption of sales.

At stake for the companies is the future of what was once one of their most promising drugs. Tysabri had been seen as the best hope in a decade for the world's 2.5 million MS patients, with potential annual sales of $3 billion.

Effects of MS

MS robs people of muscle coordination and balance, sometimes leading to damaged vision and paralysis. In severe MS, people have permanent symptoms, including partial or complete paralysis. The disease is caused when the body's immune system attacks myelin, the coating on nerve fibers.

If Tysabri is cleared to go back on the market, safety concerns may still limit sales to less than $200 million in 2008, said Chris Raymond, an analyst at Robert W. Baird & Co. in Chicago, in an interview yesterday. Rodman & Renshaw analyst Michael King in New York said U.S. demand may reach $700 million in 2010.

`Less Promising'

``The risk associated with Tysabri goes beyond just whether or not this drug will be approved,'' Raymond said today in an interview. ``Most folks do believe it will be approved and put back on the market. But I think the drug's commercial outlook is a lot less promising than it was before the risk of PML cases came up last year.''

U.S. regulators on Feb. 15 cleared Biogen and Elan to resume testing Tysabri in patients for the first time since the drug was suspended, raising hopes the advisory committee may recommend resumption of sales. The FDA is to make its decision by the end of March.

Tysabri's prescribing information should include the FDA's strictest warning, outlined in a black box, that the drug is associated with an increased risk of PML, Biogen said today. Biogen would implement strict distribution controls, the company told the panel.

Recommended Limits

Biogen and Elan recommend certain limitations, including barring the therapy for patients with impaired immune systems and not giving Tysabri in combination with other MS therapies, Burt Adelman, the Biogen executive vice president for medical research, told the committee today. Patients in two of the PML cases were taking Tysabri in combination with Biogen's Avonex, an older MS drug.

PML occurs when an infection called the JC virus, named with the initials of the first person diagnosed with it, evades the body's immune defenses and penetrates the central nervous system. Tysabri, an antibody-based medicine, was designed to treat MS by suppressing immune cells. Researchers theorize that the drug may subdue defenses meant to keep the JC virus out of the brain.

FDA reviewers raised concerns about other side effects in Tysabri patients, including viral meningitis, respiratory infections and herpes central nervous system infections. About 6 percent of Tysabri patients developed antibodies against the drug, which can decrease its effectiveness.



To contact the reporter on this story:
Angela Zimm in Gaithersburg, Maryland, at azimm@bloomberg.net
Last Updated: March 7, 2006 18:51 EST

Great News the FDA advisory commity have voted 7 to 5 in favor of returning Tysabri to the marketas a first line therepy and 12 to 0 in favor of the drug returning!

heres a link to te story....http://www.marketwatch.com/News/Story/Story.aspx?guid=%7B4547CE3B%2D376F%2D463E%2DA8BD%2D3C8BDCBF126D%7D&dist=newsfinder&siteid=google&keyword=

the use of Tysabri as a first line therepy means that if the FDA take their advisory commities advice, and they nearly always do, then the sales could be as high as first projectd before the news of the two unfortunate deaths. This makes Tysabri only the second ever drug in history that has been reinstated and approved after having been withdrawn. glad i topped up on monday now! there is a possibility that the price of elan could double when trading in their shares resumes!

Fantastic news! Do you Know when they are meant to relist Crippy?

think it is tommorow, they only suspended their trading while the FDA panel was conducting their review yesterday and today

Nice open. Well done on your well timed top up Crippy. There did seem to be some bargain prices around last week, but I didn't take advantage as it was still a gamble at that stage. Wish I had now!

Well its been a few days since the fda panel announced its decision, Tysabris on its way back but due to the problems encountered by the drug its understandable that the price didnt shoot up more than the 20% on the day of the decision. People are just waiting to see the actual hard facts of the relaunch. The FDA will be reporting at the end of the month, the 29th i think so I am hopeing for some movement on that day also when the facts are available. At the moment there is so much uninformed speculation on what the nity gritty of the drugs reapproval will actually entail, that the price is up and down on a daily bais, but hovering around 12 euro mark.

I am still optimistic that the take up of the treatment will be considerable and that it will be a first line treatment, my consultant neurologist certainly thinks so too, and being that he is at one of londons top hospitals for neurology i tend to listen to his informed opinion more than i would certain researchers. I speak of course about the piper analyst who boasted that 90% of the doctors she spoke to would not want to perscribe the drug. She forgot to mention that most of those had no direct knowledge of tysabri and gave their opion on hearsay! I think they may have been vets not human doctors :) joking aside the elan conference call the day after the fda panel anounced what their decision was was most interesting with apparently a considerable number of doctors and patients requesting to be considered for this medication so just that says to me the market for this drug is still huge and the revenues will blow all pesimists out of the water.

its just a shame that there are many vested interests that dont want to see Tysabri on the market let alone as a first line of therepy, and hence i think we may see some more propaganda aimed at shooting down Tysabri but I think the dark days are behind us now and Elan is going to reap us some rich rewards! On the horizon also is the very first treatment for altsheimers which acording to the webcast again is proving as good in the trial stages for treatment of patients as tysabri did for MS.

Important dates for Elan are going to be the 29th of march as explained earlier, the the european decision wether to grant tysabri a licence in june sometime and july/september when the altsheimers phase three data is released........happy days are here again lalalalalalallal etc :)

Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc. (NYSE: ELN) announced
today that the U.S. Food and Drug Administration (FDA) informed the companies
that the Agency will extend its regulatory review of TYSABRI(R) (natalizumab) as
a treatment for multiple sclerosis by up to 90 days.

The companies have been informed by the FDA that the Agency requires additional
time to review information regarding the TYSABRI risk management plan. Under
this revised timeline, the companies anticipate action from FDA on or before
June 28, 2006.

About Biogen Idec

Biogen Idec creates new standards of care in oncology, neurology and immunology.
As a global leader in the development, manufacturing, and commercialization of
novel therapies, Biogen Idec transforms scientific discoveries into advances in
human healthcare. For product labeling, press releases and additional
information about the company, please visit
www.biogenidec.com

frustrating news this morning...only a tempoary set back I hope, this story from bloomberg....

Elan Says U.S. Regulator Delays Tysabri for 90 Days (Update3)
March 22 (Bloomberg) -- Elan Corp. and Biogen Idec Inc. said U.S. regulators delayed the possible return of the multiple sclerosis drug Tysabri to review the companies' plan to prevent a rare side effect that killed two patients.

The Food and Drug Administration's decision on Tysabri, which was expected by March 29, will now be delayed by as much as 90 days, Dublin-based Elan said in a statement today. Elan and Cambridge, Massachusetts-based Biogen have proposed strong warnings for patients and controlled administration of the drug.

Shares of Elan, Ireland's biggest drugmaker, fell as much as 11 percent, the most in eight months. Tysabri was withdrawn more than a year ago after two patients died from a rare brain infection. Some analysts expect Tysabri to reach annual sales of more than $3 billion if the safety concerns don't cause the FDA to restrict access to the product.

``From here, it is unclear if it will take weeks or the three months for the FDA to agree on an acceptable risk management plan,'' Orla Hartford, analyst at Dublin-based NCB Stockbrokers said. ``We believe that use of Tysabri could be limited for at least three months post re-launch as infusion centers will need to be registered prior to administration.''

Hartford, who has a ``buy'' rating on the stock, has reduced 2006 forecasts in the U.S. to $20 million from $116 million. Her peak sales forecast of $1.8 billion is unchanged.

Shares of Elan fell as much as 1.38 euros, and declined 98 cents, or 8.1 percent, to 11.20 euros at 9:39 a.m. in Dublin. Biogen shares declined 1.32 euros to 39.20 euros ($47.36) after closing at $48.31 yesterday in New York.

Patient Deaths

Tysabri sales were halted on Feb. 28, 2005, on the first reported death from an infection called progressive multifocal leukoencephalopathy, or PML. The recall wiped out $17.8 billion in combined market value for Biogen and Elan that day. More extensive reviews revealed that two patients died and a third developed PML and survived.

The Elan and Biogen product had been seen as the best hope in a decade for the world's 2.5 million MS patients. MS is a neurological disorder that robs people of muscle coordination and balance, sometimes leading to damaged vision and paralysis.

The companies re-submitted the product to the FDA and patients appealed to an agency panel of doctors and scientists earlier this month to permit its reintroduction. The advisory panel voted unanimously on March 9 to support a plan to resume sales for all patients. The FDA usually follows the committee's recommendations.

Tysabri would be only the second drug put back on the U.S. market following a safety-related suspension.

Safety Plan

Elan and Biogen's safety plan for Tysabri includes administering the treatment at registered infusion centers and a requirement that all patients sign a consent form saying they have been advised of the product's risks. The medicine's prescribing information should include the FDA's strictest warning, outlined in a black box, that Tysabri is associated with an increased risk of PML, Biogen said on March 8.

Doctors will be told to suspend treatment if patients show signs of the disease and they should test for PML.

``It's a blow for the stock,'' said Ian Hunter, an analyst at Goodbody Stockbrokers with a `buy'' rating on the shares. He said the delay will mean a ``better thought through risk- management plan for Tysabri and a quicker launch after its approval in June.''

The timing of Tysabri's introduction depends on how quickly the company and regulators can complete a program to manage the risk of PML, Biogen Chief Executive Officer James Mullen said after the advisory panel's decision to back the drug. He said the companies planned to re-introduce the medicine by June.

Tysabri may be used by as many as 100,000 U.S. patients who weren't helped by or stopped taking MS drugs, Mullen said earlier this month. He declined to discuss pricing. Tysabri, given as a monthly infusion, was the most expensive MS drug at $23,500 before the withdrawal.



To contact the reporter on this story:
Etain Lavelle in London at at elavelle1@bloomberg.net.
Last Updated: March 22, 2006 05:19 EST

just means june/july is extra big month for Elan.

Like you say Crippy, a temporary set back. I am feeling confident for the long term, and the decision could come any time in that 90 day period. The price could dip further this afternoon once the US opens.

encouraging news late tonight....

Biogen, Elan retest MS drug, see FDA action by June
Thu Mar 30, 2006 2:40 AM GMT
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CHICAGO (Reuters) - Biogen Idec and Elan Corp said on Wednesday they have restarted a safety trial of its multiple sclerosis drug Tysabri, which the drugmakers recalled from the market after reports of rare brain infection were linked to the drug.

A U.S. Food and Drug Administration panel earlier this month recommended the drug be returned to the market, with mandatory controls for risks and new cases of the fatal side effect, linked to two deaths.

The companies expect an action by the FDA by June 28, 2006.

elan closed up late in new york....yippee

Glad I bought some more last week.