MY PICK IS ELN

[Websman]

It looks like the Wall Street Journal is trying to bring the share price down. I wonder why? Maybe someone wants some cheap shares before the big news comes out.

I'm not sure this article will affect the share price much. There's not a whole lot of truth to it. As a matter of fact, it's quite comical.


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The multiple-sclerosis drug Tysabri, which was withdrawn from the market this year, could be linked to new serious side effects, according to an analyst's report.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

[spikefader]

ELN is having another swing at price resistances with an explosive move intraday today from that little wedge on the daily. That gap support held and price is acting bullish again despite the poor money flow. It's working on a channel turn up today, and hopefully it will find the energy to get over the hump and into the gap. It would be nice to see an aggressive move while in it rather than the selling of the pops we've seen. I'm going to chase the channel turn up should it close that way today. I'll likely take the pivot tomorrow in that case.

[New-born baby]

Eln

Spike,
My question for you: is ELN really the best play you can find at this time?
This is not meant to be a smart alex comment. I just think there are several other plays that look better. Maybe I am wrong. I am thinking the r/r for ELN is not as good as other plays.

[spikefader]

Spike,
My question for you: is ELN really the best play you can find at this time?
This is not meant to be a smart alex comment. I just think there are several other plays that look better. Maybe I am wrong. I am thinking the r/r for ELN is not as good as other plays.

Hey New-born. Best play I can find? Well, if it fits the rules I set for myself then yep it is. You prompted me to look at it again, and here's another view - the wonderful ascending triangle: And the r/r will be a target of 13.00 for the triangle target, and the enormous gap fill target for the optimistic patient ones Very nice r/r there. It is what it is.

[New-born baby]

Thanks

Spike,
I thank you for your explanation of your reasoning. My thought was that ELN is not meeting your RSI requirements at this time. Furthermore, the oil sector is quite hot, as is BMHC. I just thought that these might make better, safer plays. JMHO.

[spikefader]

Spike,
I thank you for your explanation of your reasoning. My thought was that ELN is not meeting your RSI requirements at this time. Furthermore, the oil sector is quite hot, as is BMHC. I just thought that these might make better, safer plays. JMHO.

You're welcome. Anytime. Yep, oil is hot alright. But it's also somewhat risky fundamentally right now.

And on BMHC a very nice strong move today. But despite the move, there is still a channel short (expanding) on the daily. So while that remains, one is justified to short any intraday forthcoming SHS neckline break or double top today. Some might say,

"WHAT?! Short it!?! It's a gap up on huge volume; this puppy is heading north"!

And that may be the case. But the resistance line is the channel and it's a valid technical short. Smart traders sell resistance. And that's where it's at right now.

Should the daily channel turn up, then there's the green light to chase the intraday pivot tomorrow, because that would then be a valid long setup, at least with my rules.

Always just tryin' to keep emotion out of it!

[Websman]

Spike,

ELN will fly past your $13 target as soon as Tysabri is reintroduced. According to the latest intelligence, the big news will be coming out within the next few weeks.

You should do well.

[Websman]

http://www.wpri.com/Global/story.asp?S=3791144

CAMBRIDGE, Mass. The head of Biogen Idec says his company will recommend a stronger warning label for a multiple sclerosis drug it hopes to return to the market.
James Mullen, Biogen's chief executive and president, told The Associated Press today that the company will recommend that regulators include a warning about Tysabri's (ty-SOB'-rees) link to a rare but often-fatal brain disease.



Two deaths and one serious illness were confirmed after clinical trials of the drug. The Cambridge-based company pulled Tysabri from the market on February 28th despite hopes that it would become an important new tool in treating M-S.



Mullen says the revised label Biogen will recommend to regulators will warn patients with weak immune systems about the risks for contracting a disease known as P-M-L.



Biogen plans to ask the U-S Food and Drug Administration for permission to resume marketing Tysabri.



Biogen and Elan Corporation, its Irish partner in Tysabri, plan to submit the findings from their review of the drug's safety to the F-D-A by the end of September.

[New-born baby]

Yup

You're welcome. Anytime. Yep, oil is hot alright. But it's also somewhat risky fundamentally right now.

And on BMHC a very nice strong move today. But despite the move, there is still a channel short (expanding) on the daily. So while that remains, one is justified to short any intraday forthcoming SHS neckline break or double top today. Some might say,

"WHAT?! Short it!?! It's a gap up on huge volume; this puppy is heading north"!

And that may be the case. But the resistance line is the channel and it's a valid technical short. Smart traders sell resistance. And that's where it's at right now.

Should the daily channel turn up, then there's the green light to chase the intraday pivot tomorrow, because that would then be a valid long setup, at least with my rules.

Always just tryin' to keep emotion out of it!

Spike,
Thank you for the explanation. Yes, let's follow our rules and keep emotion out of the thing. (Not that I always do; if I had followed my own rules I wouldn't have bought KBH in the first place).

Yes, BMHC could take a fall tomorrow. That $11 pop today alone made quite a flag pole. We'll have to see if she can hold up a flag. Sometimes hurricanes can blow flagpoles down. Hopefully she can hold one up.

Would you care, in the next couple of days or so, to post a chart with a forecast about where BMHC might land? I've got quite a chunk down on her right now, with covered calls. If the stock is going to take a dive, I'll dump my shares and perhaps re-buy at a lower level (or if her future is bleak, forget rebuying the shares altogether). I would say I expect her to have a lot of momentum in the first 30 minutes tomorrow. Then the shorters may have their day. We shall see.

Thank you.

[spikefader]

Thanks Webs!

New-born, way to go on BMHC today. At close there's an expanding channel short (i.e. caution to shorts entering here) on the daily, but hey, let's face it; price resistance was taken out with power.....and now there's a gap up on huge volume that whispers runaway gap to me right now. There wasn't the perfect SHS or double top for a good short and I'm expecting bulls to buy it tomorrow and the channel will turn up. Note this: on the weekly chart, I'm counting that it's in its 5th up right now. So after some more up this week I would expect the abc correction that could span over a couple months while the dust settles from this current impulse. The trick is to know when the 5th is going to exhaust itself. Right now on the weekly it is tagging the upper channel, which is a major profit-taking signal. But it could still 'boom' and expand that channel and amaze us all with the force of the up move. If it were me I'd play it conservatively and be watching intraday patterns like a hawk, and at the first perfect double top or SHS I'd bail and put it all into KBH, which is yet to do a 5th up that I mentioned in my thread. Rotation from exhaustive moves into imminent ones. But at the same time, take what I say with a grain of salt. It is what it is until it isn't. And BMHC is solidly bullish right now. Maybe it's just as wise to sit back and enjoy the ride with a b/e stop.

[New-born baby]

Thanks Webs!

New-born, way to go on BMHC today. At close there's an expanding channel short (i.e. caution to shorts entering here) on the daily, but hey, let's face it; price resistance was taken out with power.....and now there's a gap up on huge volume that whispers runaway gap to me right now. There wasn't the perfect SHS or double top for a good short and I'm expecting bulls to buy it tomorrow and the channel will turn up. Note this: on the weekly chart, I'm counting that it's in its 5th up right now. So after some more up this week I would expect the abc correction that could span over a couple months while the dust settles from this current impulse. The trick is to know when the 5th is going to exhaust itself. Right now on the weekly it is tagging the upper channel, which is a major profit-taking signal. But it could still 'boom' and expand that channel and amaze us all with the force of the up move. If it were me I'd play it conservatively and be watching intraday patterns like a hawk, and at the first perfect double top or SHS I'd bail and put it all into KBH, which is yet to do a 5th up that I mentioned in my thread. Rotation from exhaustive moves into imminent ones. But at the same time, take what I say with a grain of salt. It is what it is until it isn't. And BMHC is solidly bullish right now. Maybe it's just as wise to sit back and enjoy the ride with a b/e stop.

Thanks!
You know, I've got covered calls out there on this one. So if I drop the stock, I have to be real sure that she's headed south. But then again, she's got to take out the $100 for the call buyer to come out close to even. It is going to be interesting.

[Websman]

My Vulcan intuition is telling me that there will b one last buying opportunity before the big move up. I look for the institutions to put out some kind of bad news this week in order to get the price down. After that it's profit time for the longs. Whether this happens or not, I'll continue holding.

[Websman]

Here's a good post from the Yahoo board. I'm also posting two links for sites with some good Tysabri info. You better get strapped in and hang on tight. It's going to be a wild ride.

http://www.biopractical.com/

http://www.tixx.com/elan.htm

lets re-visit - fast times coming
by: pinvestment09/05/05 10:28 am
Msg: 766755 of 766791
and these are the timepoints as suggested by the companies

I think that the if the trials indeed start in the next couple of days or weeks then that signals that the FDA has been seeing the data all along - I think that would allow a very rapid review by the FDA

over this week I hope to have some very strong analyses to post that shows why tysabri uptake will be rapid and why FDA action should be swift - in short the FDA has not seen such an effective drug where other treatments are not adequate - more people died from the marketing of penicillin - just look at remicade, rituxan, and enbrel among many others to see the risk profile accepted by the FDA - and remember ty mono shows little risk at all compared to placebo treated patients (yes - Harr from MS you have to compare to the control population)

well ELN had a nice week - starting with tuesday next week I believe we are in a period of time that might be filled with plenty of good news

sept 6 - 16 is my guess for when safety data is released with a full FDA submission shortly thereafter - the market seems to be realizing that Ty mono is coming back to the market - they do not seem to understand why it will be a blockbuster - i know that mullen and others have a longer time frame for FDA review which is strange because he said FDA would complete review in 45 days - i still think a nov/dec advisory committee meeting is very possible and i can explain those reasons at a later date

but this is what i hope to become clear in the next 3 weeks -

1. release of final portion of safety data ++++(no PML)
2. some notice of trials restarting
3. FDA pulling moratorium on trials restarting
4. BIIB/ELN sending in full safety data with 2 year trials results with label changes also

then from 3-4 weeks

5. ECTRIMS meeting with data of tysabri disability reversal, with presentations on JC virus found in untreated and beta interferon treated MS patients - the finer details of the safety review for tysabri

october/november

6. EMEA action
7. notice of FDA meeting (if necessary)

november/december

8. FDA meeting / tysabri preliminary re-approval possible marketing begins

***********
and throw in any drug delivery news and any little bit of aab-001 news and you have an explosive situation to the upside
- i think it is like a stick of dynamite over the upcoming period (and that stick of dynamite is sitting on a nuclear bomb called aab-001) - and nobody is acting like the fuse is counting down on the nuclear bomb

[noshadyldy]

ELN's CEO sells 200,000 shares recently and director another 163,000. Just trading options or are they ahead of the press release that creates the buying opportunity? (this is one heck of a ride! must get more wild berry malanta)

[Websman]

This is why it is so urgent that Tysabri be put back on the market...

http://www.deannandlenny.com/

Yes I Have MS But . .
...This Page is for Family And/Or Friends of People With MS





Hello, my name is Deann and I have MS. I was diagnosed November 7th, 2000 (Election Day). I was a Tysabri user until they took it off the market. I hope it comes back because I did well on it. But, I understand why they did it. Right now I'm on nothing until the doctor tells me what to do.</B>

Anyway, that guy next to me is my wonderful husband Lenny, hence the Website address www.deannandlenny.com. After I learned more about the disease, I educated my family, friends and coworkers and I was lucky, they all understood. Those of you who don't understand should educate yourself about the disease since someone you know now has it.

Let me explain the phrase "You Look So Good". One thing that MS does not have the power to do is to change a persons face or figure. We will always look the same whether the disease is in remission or progressing or when standing or in a wheelchair. So thanks for the comment, but it really has nothing to do with MS. Sometimes that phrase can also be hurtful when we are in pain or feeling bad. You may not understand what is going on with us because we might still look fine so we think you don't believe us.

This group of people (except me) are one of the teams at the Maryland Center for MS.


Starting from the left is Dr. Robert Shin, MD, Assistant Professor of Neurology and Ophthalmology. Dr. Shin is my MS Physician and also was heading up the Antegren/Avonex Trial that I was participating in. I soon will be doing another Tysabri trial in the upcoming months (today's date is 8/31/2005). Dr. Shin is one of the most caring neurologist that I have ever met.

Next is Valerie Wells, Research Coordinator, she is in charge of all the fun testing like the adding test, peg in the hole test, vision test, my timed walking test, etc. When I start the new trial hopefully I'll have the vision test again and I will blow her away since I had Lasik a few months back and see 20/15 left eye and 20/20 right eye. I have fun with her by laughing at how bad I do on the tests. I think the folks at Biogin/Elan should take that adding test - don't you agree Valerie?

Next is silly me (we will skip me).

Now we have my MS Nurse Kerry Naunton, RN, BSN. She is the one who has the pleasure of sticking me with needles once a month. I think that she has to be a saint for putting up with me and the funny faces I've made during my infusion prep. As far as MS goes, she's one smart cookie. Not only do I consider her my one and only MS nurse, but a good friend as well.

Last but not least is Dr. Horea Rus, M.D., Ph.D., Assistant Professor (Research). He is the doctor who is considered the "blinded" doc in the study(s). He did full neurological exams on me every three months which was part of the Antegren/Avonex trial. Hopefully he will be working with me in the new trial. It's a good thing he holds on to me and keeps me steady during some of my walking test, otherwise I would probably end up with several concussions. We have here another doctor who is very caring.

I think the Maryland Center for MS must only hire caring doctors, nurses & coordinators. I have yet to find a physician here that I would like to kick out the window. I've had a few MS docs that could learn patient respect from everyone above. If you ever have the opportunity to be seen by someone here, take it! Here is a link to their website:

Maryland Center for MS