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| | From:  trader1963 (Original Message) | Sent: 5/21/2007 2:30 PM |
Kutz, what is your analysis on the new trial announcement........I have been in and out for years............ Elan and Wyeth to initiate Phase 3 clinical trial of Bapineuzumab in Alzheimer's disease Co and Wyeth (WYE) announce the decision to initiate a Phase 3 clinical program of their lead immunotherapeutic candidate, Bapineuzumab, for the treatment of patients with mild to moderate Alzheimer's Disease. This decision was based on the seriousness of the disease and the totality of what the companies have learned from their immunotherapy programs, including a scheduled Interim look at data from an ongoing Phase 2 study, which remains blinded. Phase 3 clinical trial design will be finalized with regulatory agencies, and subject to regulatory approval, it is intended for the trial to begin in 2H07. trader  |
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go Kutz... a little pop today... saw something on tv about no new cases of this brain disease in the US... ELN got up to $14.80 intra-day... ELN ELAN CORP PLC | Last [Tick] | 14.25[ + ] | | Change |  0.66 | | % Change | 4.86% | |
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| | | From: Kutz | Sent: 8/25/2008 11:04 PM |
The two newer cases seen were in Europe versus the US. In the US, qualifying patients must be seriously screened and followed during chronic administration of this drug. The FDA was strict on this coming out of banning use! In the EU, the label was weaker and lead to doctors doing the screening but slacking off on the follow-up. The condition seems to appear in increasing numbers later in administration (related to the immune system changes that occur) and if monitored closely can be caught before it becomes serious. Therefore the EU needs to tighten requirements for patient monitoring! I seriously doubt anything is coming of the Tysabri situation in the US at all! Just a bit under a couple grand ahead to date. Have not decided how far to take this? You got the buyout rumors, the selling of a division out there, and classic recovery in the PPS over an overreaction? We will see! It was my biggest winner today. Kutz |
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| | | From: Kutz | Sent: 8/25/2008 11:35 PM |
Here is what the FDA has decided to do. Just came out tonight! Basically it is to alter the black box label with additional messages about monotherapy with tysabri versus multi-therapy in addition to Tysabri! Yawn! This will not change sales of Tysabri at all in the US. its the only thing that provides patient relief. they are more afraid of what will happen if they don't take it! Now I await some jackass analysts to say this is damaging to the sales formula and try and drive this down! It would all be a bunch of crap! The markets not great currently. In a decent market this should have at least a target of $20-22. I'll hold my shares and see what the EU regulatory authorities say! Kutz  |
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kutz it is not over yet.......the FDA is totally unpredictable and all it will take is a few more cases of the brain disorder and poof gone just like Vioxx........I hope not but who knows.....I an still waiting for all of the info to emerge.........I guess I am a little anal after being lied to about all of the profits claimed in the past by Elan.........I am in the green big time but had some big losses to start........
trader |
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| | | From: Kutz | Sent: 8/26/2008 12:53 AM |
Trader: ELN management has been "lets say" loose with their guidence in the past, and the FDA is always a wild card (I have surely danced with the FDA many times), but respectfully, this is a trade for me and not a long term investment like say SSW or BQI (weeks versus months or years). there is no way to predict how the market will react in the morning given even the PR today (should be nothing)? I totally understand you gun shy nature on this ticker currently but, unless there are cases of this condition hiding right now that have not been made public, there is a nice space to trade this to me given the gigantic drop in PPS over the last several weeks. There is no way anyone could predict this stuuf just like there was no way to hear up front about the two cases of PML in Europe? There is the unit sale to consider that about terminates their debt. I will duly note the concerns you bring up and keep them in mind! If it goes above $15.00 I'll initiate some protection. I will take my chances on this one and continue to watch it closely. I may only be in it it a couple/three weeks more anyway. In this market you need to take your profit when you can and I really want to back out of this market in general soon after Labor Day. It will be clear based on planned selling I do in the next few weeks! I got a couple of turkeys to sell too! Kutz  |
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| | | From: Kutz | Sent: 8/26/2008 11:06 PM |
Latest from Forbes: Assessment of ELN going forward! Its on the positive side and I am sure one can find negative spins as well. I chose to post because it does a good job of framing the arguments for the Alzheimers drug development and Tysabri safety situation to me and Greedy has stated his interest in learning how these tick. Greedy has seen what the market does to bad drug news and now he should see the latter, more in depth analysis of the risk and actual potential and the ways this can go. The science never matters when Wallstreet goes ballistic-generally overreacts. Then the science takes over and stuff that happens is not always the drug companies fault. Even this report does not expect gigantic moves back to where it was-its become more risky in general, but this company is not dead at all! Far from it. Enjoy! kutz  |
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| | | From: Kutz | Sent: 8/26/2008 11:34 PM |
Just to add, I picked a target of $20-22.00 (when this was above $36.00) in an earlier post down the road because I have always thought that analyst 2012 predictions for Tysabri sales were pumped up and the value of the company is currently HIGH based on the actual 2008 Tysabri sales versus predicitions-lots of wiggle room and uncertainity!. In this situation I took the high of $36.00, subtracted $10.00 for the new risk of more PML coming out in the future that alters the seen 1-3 to 5000 risk of PML and what I consider to be bloated sales calculations. Then I factor another $4.00-6.00 on Phase 3 Alzheimer rsults actually improving/reducing the results seen in the already reported Phase 2 trials. This is not coming out for a while! I think that $20.00-22.00 is reasonably safe over time and their sale of their speciality unit and or a buyout possibilities at this lower PPS are wildcards that can propel this higher quicker! As Trader says, more PML cases surfacing could whack this again. Its a chance you take in drug plays! What I like here is the potential upward movement versus no FDA drug decisions far into the future unless more PML surfaces! JMO Kutz |
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Thanks Kutz... I'll take all the help I can get...  ... particularily with the drug stocks... |
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| | | From: Kutz | Sent: 9/3/2008 5:12 PM |
Big developments in Alzheimers today! The race is on and this explains why ELN and their partner rushed into P3! They now have serious competition and the competition just got a dose of Viagra-LOL PFE has cut a big deal with this baby bio and now they are in a race with ELN and their respective big pharma partner. There are a couple others too! This is a very important point: Medivation PPS is what? with no drug sales and ELN is what? PPS with Tysabri sales. No team here has any special advantage in their development program. This is why I am still hanging in ELN-to me its over sold! Currently ELN has drifted back and settled for now. Kutz |
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Looks like a buying opp. going back to single digits......I am a buyer close to 5-7...
trader |
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| | | From: Kutz | Sent: 9/11/2008 5:43 PM |
ELN: Never say never, but I doubt it will get to 5-7. Expect news soon on selling of speciality division-use funds to retire most of their heavy debt. Down the road I expect them to get bought out? Tysabri implicated in a couple of skin cancer safety cases recently-in the aged patient population, it does not seem to be about safety for Tysabri. Actually looking at this drug to help with oncology indications. Appears range-bound to me until next quarters eanings indicate damage/lack of damage to Tysabri sales. Phase III Alzheimers proceeds. Still nothing important from the FDA regarding Tysabri safety. I hold my currently lightly profitable shares. JMO Kutz  |
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| | | From: Kutz | Sent: 10/30/2008 1:51 PM |
Oh Oh! Third brain disease case! Glad I got out of this a few weeks ago (posted within the dow thread with other sells)! Trader was worried this would happen! I don't think it will change anything the FDA does with this drug-again these patients would rather risk the brain disorder vs their disease they are being treated for. bet it still doesn't come off the market-would have to be dozens of cases. The problem is the BIIB/ELN PPS will take a dump everytime it happens whether it results in anything serious or not. The entire medicalinvesting world is now too sensitized to this issue and adverse event. ELN has been getting more bad streams of news too. About a week back their partnership with WYE took a turn for the worse, when the EU asked that their P3 Alzheimer trials be delayed for further review and potential changes as a result of some P2 study results. These were the studies Trader asked about and I discussed months ago with him and I specifically remembered saying they were rolling these out fast (before other results) and taking liberties with the timeline of the process. Well now the EU has slapped their fingers here. They took a calculated risk to save time-THEY LOST! Finally the speciality division of ELN has not been sold yet. I assume it will, but imagine its delayed because of credit and financial issues currently festering in the world! Tick, tack, toe, three in a row! Ouch for them! Kutz  |
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| | | From: Kutz | Sent: 10/30/2008 2:15 PM |
A couple added points for drug company educational reasons. May help someone thinking about a drug company investment long after RAZF is gone: (1) The affected patient is a US woman who developed this after 18 Tysabri treatments (on it for a while-thats been the MO here on these events) and her condition was monitored, caught, she is being treated, and we hope she will recover from this brain condition (PML). Bet she still wants Tysabri if cured of PML! PML is treatable and if monitored properly can be taken care of. (2) Regarding WYE and ELN trying to start these Alzheimer studies too fast, go back to Kutz's posts in Post3 (Item listed #2) and Post 4. Maybe these companies should hire me to run their programs? I know why they did it-it was cutting corners because of multiple companies current development of many Alzheimer drugs and the "race" that is in progress in this market. Its a big one! But when marketing decisions take precident over good science decisions, this is what happens in pharma companies and their PPS and we ultimately suffers. Happens all the time. I have trained more doctors (smart ones) often recommended by marketing departments because they buy large numbers of drugs from a company and yet they have absolutely no understanding how to do regulated clinical research studies. its different than just treating patients. They are smart, but not always when it comes to everything! This adds to the risk in developing drugs and investing in them! Its a mine field to sort through. Why many avoid drug investment. Kutz |
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This PML is not good advertising for ELN and is going to cost the share holders........... Nice work Kutz between you and Frankie you guys are about the only folks I give any credence to your posts.......
thanks
trader |
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| | | From: Kutz | Sent: 1/14/2009 1:59 PM |
ELN clarifies mistakes in PR in the news world. They are also looking to potentially sell now either pieces or the entire company. It could happen during 2009, but their are stipulations and rules already within their collaborations. I guess you will more likely see selling pieces? pharma unlike banks have deep pockets with serious cash! Kutz |
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