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spike what do your charts say ?????
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Looking good for tomorrow. I've just about made up my loss from a month ago, when the Boston Globe caused me to stop out.
I think I'm going to be very glad I got back in.Comment
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I am hearing that the top PLML Doctor is now pro Tysabri after being very cautious about the drug while the review was taking place. this is a very good sign.Comment
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Should the FDA Always 'Err on the Side of Safety'?
By Henry I. Miller Published 07/20/2005
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TCS
These are turbulent times for the FDA. The almost daily barrage of negative headlines questioning the safety of marketed drugs is likely depleting regulators' individual stocks of aspirin and antacids. But as they try to soothe their own pain, regulators must not forget their mission -- to ease the plight of patients who need new medicines.
Past criticism of FDA mostly concentrated on what arguably remains the agency's most important shortcoming: the delays and escalating expense of getting drugs through the development pipeline and into the marketplace. Lately, however, events have shifted the focus to issues of safety. First there were claims that the labeling of certain antidepressants failed to warn doctors that the drugs caused some adolescents to commit suicide. Then the agency was blind-sided by contamination that made half the nation's flu vaccine supply unavailable. Finally, there were revelations about previously unknown side effects of several widely prescribed anti-inflammatory analgesic drugs.
Regulators' increasing sensitivity to safety concerns may have become contagious: Drug manufacturers, too, seem to have begun to "err on the side of safety" to a degree that causes safe and effective drugs to be taken off the market voluntarily.
Consider Tysabri, only the sixth medication approved -- and the first in several years -- for the treatment of Multiple Sclerosis (MS), a debilitating autoimmune disease that affects the central nervous system. The stunning results of the drug's testing in clinical trials -- the frequency of clinical relapses was cut by more than half -- induced FDA to grant accelerated approval last fall. MS patients eagerly put their names on waiting lists to get the medicine.
But this ray of hope for MS sufferers was short-lived. By the time that several thousand patients were being treated with Tysabri, three confirmed cases of a rare neurological disorder caused by a virus were reported. (Because the drug suppresses certain aspects of the immune response, regulators, clinicians and the drug's developers had from the beginning been sensitive to the possibility of infections as a side effect.)
Immediately -- some would say prematurely -- the manufacturers of the medicine voluntarily halted production and distribution and withdrew Tysabri from the market. MS victims and many neurologists were bitterly disappointed. Now they can only hope that a comprehensive review that is under way of all the clinical data -- including the results of new diagnostic tests being conducted on Tysabri recipients -- will permit a return of the drug to the market.
The "safety" of a drug is a relative thing. Safety and efficacy, the two criteria required for marketing approval of a drug, are inextricably linked. Regulators' judgments require a global and often difficult calculation of risk and benefit, including consideration of what alternative therapies are available. We would tolerate greater uncertainty and more severe side effects for a potential cure for pancreatic cancer or AIDS, for example, than for treating heartburn. When FDA grants marketing approval, the drug is deemed to be safe and effective for the conditions on the label.
In the current climate of litigiousness and antipathy to big companies, one can understand the haste to withdraw Tysabri voluntarily from the market. What is also understandable (and lamentable) is the chattering classes' hyping of the drug's health concerns and of the stock market impacts of the withdrawal, while ignoring that real people who were able to lead more normal lives with Tysabri are now prevented from obtaining it.
Another casualty of the withdrawal is the ability of patients, after consultation with their health care providers, to make informed decisions about possible treatment options. That fundamental right should not be usurped by risk-averse, publicity-shy bureaucrats, anti-FDA healthcare activists, or members of Congress.
As more breakthrough drugs come before FDA for approval, the agency must curb its paternalistic instincts and find a way to balance more sensibly the assurance of safety with patients' right to assume responsibility for their own medical decisions. This would be a sea change for FDA, which in many areas -- "off-label" prescribing, and dissemination of new information about drug therapy, among others -- has sought repeatedly to limit the discretion of physicians and patients to make treatment decisions.
To this point, FDA has been even-handed in its treatment of Tysabri. The clinical data justified the accelerated approval; the ongoing analysis of safety data is a responsible action; and if the data support it, FDA should work with Tysabri's producers to move rapidly toward reintroduction of the drug. Labeling restrictions, such as a prominent "black box" warning or strict limitations on which patients can receive a drug, are "risk-management" options within FDA's purview. In any case, the agency's actions must be driven by the data.
The notion that FDA should "err on the side of safety" must be qualified for patients with incurable or poorly treatable diseases: For them, there is no safety in the status quo, and we only damage them further with paternalistic public policy that prevents individuals from exercising their own judgment about risks and benefits. If FDA must err, it should be on the side of patients' freedom to choose.
Henry I. Miller, a physician and fellow at the Hoover Institution and Competitive Enterprise Institute, headed the FDA's Office of Biotechnology from 1989-1993. His most recent book," The Frankenfood Myth," was chosen by Barron's as one of the 25 Best Books of 2004.
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It's all good at the moment.Originally posted by kingofthehill
Channel turn up at the close today!
Of particular note is there was an upper channel tag on Monday, which is a profit-taking signal, yet price is ignoring it......this is very bullish.
I am not going to be surprised if/when there is an explosion up in the next several trading days....
$7.90 is strong support.
But many a slip between the cup and the lip! The caveat on my bullishness is if there is an hourly close below that $7.90. This would likely see a return to $7.40 and while this would be a great place to be entering a support long play, any lower does damage to the chart. And Below that, the next good support is the daily channel at 6.00 and rising. But a break below 6.30 is very bad so we don't want that.Comment
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Hate to be the bearer of bad news, but ELN is showing signs of weakness and I'm bearish on it for next week. I've given it the chance to impress, and it's remained stagnant just when it should be bullish. Barring a strong gap up over $8.00, I'll be closing out first thing Monday and happily pocket my 14% and go back into the bushes.
Why? Well, the hourly candle did close below the $7.90 area I referenced. 2 days ago, the strong opening at $8.12 made a mere 1 penny advance and then no attempt for higher prices. Instead, a couple million shares were traded as it fell 4.6% over the next 90 mins to $7.74. Then later in the day it had the hourly close beneath the bollinger band I reference in the chart. Yesterday it opened at hourly channel resistance and sold of with pace and flat-lined in a 4 penny range for the entire afternoon, even when the broader market rallied strongly to close. This non-participation is a loud whisper that no-one is interested in it at this resistance area. In fact, 2 days ago was a channel short day. And now there is a quadruple top in place there; 7.94, 8.42, 7.96, and 8.15. Every time price opens or works its way up towards 8.00 it's getting sold. So we can feel confident that there is heavy resistance at 8.00. Close yesterday was 7.79 and I'm anticipating a fairly quick drop next week to the channel test. And I'm not going to be surprised if it tests the $5.50 area. Right now, smart money exits to wait for resistance to turn into support. Right now, smart money waits on the sidelines for a bargain entry point. There was an absolutely clear chance for ELN to burst up....and I saw it, posted it about it my last post, waited for it, expected it, and watched with disappointment as it never came. Like that song goes, "Ya gotta know when to hold 'em, know when to fold 'em, know when to walk away, and know when to run", well....it's time for me to fold 'em, take my profit, be happy, and wait until the $8.00 resistance area gets smashed by a bigger fish than I, or until price drops for another screaming bargain down at $5.50 area. The more I ponder the technicals, the more I'm feeling the distinct feeling of the hairs raising on the back of my neck as a big bearish shark is lurking in the dark water. I'm outa here dudes....back to the safety of shallow water and will stalk my next opportunity with ELN. I strongly urge others to ponder these thoughts and determine where they fit into your trading plans.
The daily shows the bigger channel that price may meander between. That hourly chart opens the door to a gap fill I reference below, and a test of the lower channel line.
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ELN is going up after hours after very positive comments on TY from the BIIB conference call. Looks like ELN is off and running...
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Spike well thought out Thanks for the info i was away for a few days ... keep me informed on you r ideas even if you dont trade them
COPY AND PASTE ***********************
Tuesday, July 26, 2005
Tysabri Update from Biogen
i'm listening to the biogen Q2 call right now. there are no material developments, but the executives are very upbeat about the reviews. jim mullen, the CEO, said that it is too early to make any conclusions, but that the MS portion of the review is almost complete. i assume that the crohns patient reviews are the holdup. he has reiterated that reviews should be done "by the end of summer." jim mullen also stated that studies on PML have been very fruitful and that onset of PML can be detected and managed. the important inference to make here is that there have been no new confirmed PML cases!
also, biogenidec is continuing to fund development on the high titer process for tysabri, which allows higher production capacity for the drug. according to the financial officer, peter, "we are assuming that tysabri is only temporarily suspended".
the KEY point that one of the executives brought up is the restart of tysabri trials. he stated that in the coming weeks, biogen/elan could be in talks with the FDA and EU regulatory agencies to restart tysabri trials for MS patients. he is most likely referring to a restart of the tysabri 1808 ms trials.
i continue to be very upbeat on the future of tysabri, and i'm looking forward to ELN's call on thursday.
Significant Q/A Session Information
-Someone asked biogen to confirm that there are 3 cases of PML, but biogen refused to comment because it is too early to make conclusions from the safety evaluations. Instead, he reiterated that Biogen intends to push the FDA and EU regulatory agency to allow MS Tysabri trials to restart.
-The expenses associated with developing the high-titer process will create some additional charges in Q3, but they will be "continuing to produce Tysabri throughout the year."
-Tysabri's sales team has been temporarily reassigned to pitch Avonex, but the sales force for Tysabri is still availible for the relaunch of Tysabri.
-The executives made fun of the Boston Globe and WSJ during the call (they reported a 4th and 5th 'case' of PML last month).
-Clinical trials might restart before commerical relaunch of Tysabri. Resuming clinical trials is more simple FDA-wise than a commercial relaunch because of potential labeling issues.
-FINALLY!! THE END OF SUMMER HAS BEEN DEFINED! The exec during the Q/A threw out the date September 21st as their definition of the "end of summer."
-"Have you guys sent the data to the FDA necessary to take the hold off trials" *silence* "No." *next question*.
copied from a blogComment
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We believe Elan continues to be optimism on the return of Tysabri to the market
following the completion of the on-going safety review. The completion of the safety
review was defined yesterday as (i) the collection of data from all 3,000 patients on
Tysabri in clinical trials, (ii) the analysis of the data and (iii) discussion of the data with
the FDA. Completion of this review is anticipated by the end of the summer (21st
September 2005 as defined by BiogenIdec) at the latest and at this time we expect the
key headline findings from the review to be announced and for a decision to be made
by the FDA on the path forward for Tysabri. No decision has been made by the FDA on
whether an advisory panel meeting would be convened to review the data, although we
would expect an update on this by late September 2005.
• Once the FDA has reviewed the safety data from the patients who participated in the
MS studies it is possible that the clinical trials can be re-started. BiogenIdec and Elan
have initiated a process to resume clinical studies (the 1808 trial) in MS and expect to
begin discussions with the FDA shortly regarding protocol amendments for this trial. As
neither Crohn’s disease or rheumatoid arthritis are approved indications, no discussions
have yet been initiated with the FDA for resumption of dosing in patients for these two
indications. In Europe, discussions will be initiated with the European regulators for the
MS and Crohn’s disease when the data from the on-going patient review is fully
evaluated.
• Study 1808 is an open label extension study involving patients that have completed
clinical studies involving (i) Tysabri as a monotherapy, (ii) Tysabri in combination with
AVONEX and (iii) Tysabri in combination with Copaxone. The 1808 study protocol is to
be revised and during this process a decision will be made on the scope of these trials
(i.e. whether patients will receive Tysabri alone or Tysabri in combination with
AVONEX). Based on our analysis of the pharmacokinetic data from the combination
trials, we currently see no reason to re-commence studies involving Tysabri in
combination with AVONEX. We believe from this analysis that there is a very solid
basis as to why combination therapy is an issue.
• We have made minimal adjustments to our sum-of-the-parts assessment following
yesterday’s results and the valuation range remains $9.74-$11.95. The key catalyst
from here is a positive outcome to the upcoming discussions with the FDA with Tysabri
returning to the market. Over the next 1-2 months we expect to get an update on this.
The stock is high risk and speculative. We maintain our Buy recommendationComment
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Here's an interesting post from the Yahoo board...
Ever since the "Tribulation" of the Elan Faithful occurred on February 28, 2005, I have had the feeling that owning Elan stock has become less of an investment opportunity and more akin to a religious experience .
Everyday, I witness our ELN congregation gather to read the SCRIPTURES (nearly 750,000 of them) from their message board BIBLE for inspiration. We daily seek out our PROPHETS (verysmellynelly, GTRT, rxdudette, etc.) for their predictions of what will come. And in the darker times, we consult our EYMB high priests (pinvestment, neuro 1111, etc.) for additional strength in our faith and a firmer courage to ward off any opposing demon.
Like any respectable religion, we have our MIRACLES (Tysabri, AD resesrch), our defiant BLASPHEMERS (pick any antagonistic short), and our heavenly ANGELS (elan lindsey, LJD, etc.). But what we have most (perhaps, a little too much) is an abundance of FAITH in our "Elanism."
One reason Elanites need to rely so heavily on faith is because our Pontiff Kelly continues to be a man of very few words. Some skeptic followers contend this is also true of his actions. One sect of the congregation feels it is HERETICAL to doubt his INFALLIBILITY and we are required to accept his diminished dogma as a test of their true-believer’s stance. However, many others, even those that once personally experienced the Tysabri Miracle, are left with serious questions.
With or without our pontiff pontificating, all believer see the DAY OF RECKONING is at hand. Whether in the blink of an eye, weeks, or months away, the long-awaited RESURRECTION of Tysabri will be the HOLY DAY that will confirm what is now mostly taken on faith.
This event, more than any other to date, will also determine the fate of our afterlife reward.
Should our destiny be one tormented by the all-encompassing flames of a pauper’s HELL? Or, are we finally ready to ascend into the glorious peace of a curative and financial HEAVEN?
Let us pray...Comment
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from the Dublin stockbrokerage house that said Tysabri woulw not retrun a few months ago ....seems they have changed thier tune
Tysabri decision ever nearer.
Elan's long term performance hinges on the progress of Tysabri. From both Biogen Idec and Elan conference calls, we believe that this review is more advanced than previously thought. In particular, Elan management specifically detailed that the completion of the safety review involved (i) gathering of data from patients; (ii) analysis of that data; and (iii) review and discussion with the FDA. Until now, we understood the process to only cover the first two actions. The timing of any subsequent safety/advisory committee review, however, still remains unquantifiable. The indication that both companies are looking to re-activate a post-approval study signals, we believe, (i) both companies' conviction that Tysabri is on the way back; (ii) that the patients to be re-enrolled in the study have passed the PML review and are seen as fit to resume Tysabri treatment; and (iii) that the companies consider the FDA would be disposed to allowing such studies to go ahead. The only questions now, we believe, are the timing of the drug's return (not if) and what level of sales it will command. On both issues, we are sticking to our projections detailed in our June 2nd report, namely a return in early 2006, sales of $239.0m in that year (100% booked by Elan as all for MS in the US), rising to a peak of $1.77bn in 2009 (70% booked by Elan (US sales plus share of RoW profits), 30% by Biogen Idec (RoW sales). On the back of Q2'05 results and subsequent guidance, we have marginally adjusted our revenue numbers downwards out to 2007. The additional flagged costs in FY05 without the Tysabri income balance, result in an almost 17% drop in forecast fully diluted losses for the year to $1.05 from $0.90. The Tysabri weighting to the model from 2006 onwards, dampens any margin changes in the ongoing business, leaving FY06 losses virtually unchanged and FY07 earnings little changed in absolute terms.Comment
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Jim Cramer called ELN "comatose", and has told everyone on his show to sell.
The sad part is that people actually listen to him. They're going to be pissed when ELN takes off without them.Comment
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Cramer is nuts....... not on this one pick..... but in gerneral...... I don't listen to him but I do watch his Mad Money tv show often....... the guy is hysterical...... even read his Street Addict book about his life.........Originally posted by Websman
Again.......
The guy is nuts........ He makes me laugh........
I think Cramer has lost as much money for people as he has made it on tv and in his radio show......... ELN will be another one...... which way.... don't know yet.... but I am in next week early!Gotta love the big board!Comment
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