MY PICK IS ELN

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  • kingofthehill
    Senior Member
    • Nov 2003
    • 487

    ahemmm 9.86

    Comment

    • spikefader
      Senior Member
      • Apr 2004
      • 7175

      Originally posted by Websman
      Ahhh, there you are Spike. I was hoping you'd bring me back down to earth. lol
      Well how's this for down-to-earth: My short setup failed for -1% today and I'm a bull if it closes over 10.00. It's in the progress of doing exactly what it needed to do; act bullishly! May it fill the gap and make yall a kazillion! I'm stalkin it for a long now.

      Comment

      • Websman
        Senior Member
        • Apr 2004
        • 5545

        I'm glad I held!

        Comment

        • skiracer
          Senior Member
          • Dec 2004
          • 6314

          Good for you Webs, every Vulcan deserves a bone now an then.
          THE SKIRACER'S EDGE: MAKE THE EDGE IN YOUR FAVOR

          Comment

          • kingofthehill
            Senior Member
            • Nov 2003
            • 487

            WE’VE ONLY JUST BEGUN

            sound catchy maybe i shoud write a song

            Comment

            • kingofthehill
              Senior Member
              • Nov 2003
              • 487

              nice run , what do you see spike

              Comment

              • Websman
                Senior Member
                • Apr 2004
                • 5545

                So what's next for ELN? Do we keep running up or do we correct?

                My initial Vulcan instinct tells me to look for a correction. I'll have to check the charts to confirm my suspicions.

                Comment

                • kingofthehill
                  Senior Member
                  • Nov 2003
                  • 487

                  yeahhhhhhhhhhhhh babbbbbbbbbbbbbbbbbbbyyyyyyyyyyyyyyy


                  Biogen Idec and Elan Announce FDA Acceptance of Supplemental Biologics License Application and Priority Review Designation for TYSABRI(R) in Multiple Sclerosis
                  Thursday November 17, 4:44 pm ET


                  CAMBRIDGE, Mass. and DUBLIN, Ireland--(BUSINESS WIRE)--Nov. 17, 2005--Biogen Idec (NASDAQ: BIIB - News) and Elan Corporation, plc (NYSE: ELN - News) announced today that the supplemental Biologics License Application (sBLA) for TYSABRI® (natalizumab) for the treatment of multiple sclerosis (MS) has been accepted and designated for Priority Review by the U.S. Food and Drug Administration (FDA).
                  The FDA grants Priority Review status to products that are considered to be potentially significant therapeutic advancements over existing therapies that address an unmet medical need. Based on the FDA's designation of Priority Review for TYSABRI in MS, the companies anticipate action by the Agency approximately six months from the submission date, rather than 10 months for a standard review. On September 26, 2005, the companies announced they had submitted the sBLA for the market re-entry of TYSABRI for MS and requested Priority Review.

                  The sBLA for TYSABRI in MS includes:

                  final two-year data from the Phase III AFFIRM monotherapy trial and SENTINEL add-on trial with AVONEX® (Interferon beta-1a) in MS;
                  integrated safety assessment of patients treated with TYSABRI in clinical trials; and
                  revised label and risk management plan.
                  "We are pleased that TYSABRI has received Priority Review designation, which we believe, reflects the unmet need in MS," said Burt Adelman, MD, executive vice president, Development, Biogen Idec. "We look forward to working with the FDA throughout the review process and are hopeful that we will be able to bring TYSABRI back to people living with MS."

                  "We believe that the acceptance of the sBLA for Priority Review is another step in our ongoing commitment to provide TYSABRI as a treatment option for MS patients in need," said Lars Ekman, MD, executive vice president and president, Research & Development, Elan. "We will continue to work closely with the FDA as they review the filing so that TYSABRI can be made available with an appropriate benefit-risk profile."

                  Comment

                  • Websman
                    Senior Member
                    • Apr 2004
                    • 5545

                    Looks like tomorrow should be quite profitable, huh King?

                    Comment

                    • Websman
                      Senior Member
                      • Apr 2004
                      • 5545

                      Watch the AH action!

                      BWAAAAHAHAHAAAAAAAAAAAAAAA!!!!!!

                      YEEEEEEEEEEEEHAAAAAAAAAAAAAAAA!!!!

                      Comment

                      • jiesen
                        Senior Member
                        • Sep 2003
                        • 5321

                        Excellent!

                        This is indeed great news for ELN, though I don't the AH action really reflecting it. Of course, this news is to be expected, just as Tysabri is expected to be back on the market, given that ELN is trading at more than $5. This news definitely increases my interest in the stock, though, and if it's still trading at $10 after the initial euphoria dies down, I may even pick up some shares again. When Tysabri is back on the market, $30 is practically a given.

                        At Yahoo Finance, you get free stock quotes, up-to-date news, portfolio management resources, international market data, social interaction and mortgage rates that help you manage your financial life.




                        Biogen Idec and Elan Announce FDA Acceptance of Supplemental Biologics License Application and Priority Review Designation for TYSABRI(R) in Multiple Sclerosis
                        Thursday November 17, 4:44 pm ET

                        CAMBRIDGE, Mass. and DUBLIN, Ireland--(BUSINESS WIRE)--Nov. 17, 2005--Biogen Idec (NASDAQ: BIIB - News) and Elan Corporation, plc (NYSE: ELN - News) announced today that the supplemental Biologics License Application (sBLA) for TYSABRI® (natalizumab) for the treatment of multiple sclerosis (MS) has been accepted and designated for Priority Review by the U.S. Food and Drug Administration (FDA).

                        The FDA grants Priority Review status to products that are considered to be potentially significant therapeutic advancements over existing therapies that address an unmet medical need. Based on the FDA's designation of Priority Review for TYSABRI in MS, the companies anticipate action by the Agency approximately six months from the submission date, rather than 10 months for a standard review. On September 26, 2005, the companies announced they had submitted the sBLA for the market re-entry of TYSABRI for MS and requested Priority Review.

                        The sBLA for TYSABRI in MS includes:
                        • final two-year data from the Phase III AFFIRM monotherapy trial and SENTINEL add-on trial with AVONEX® (Interferon beta-1a) in MS;
                        • integrated safety assessment of patients treated with TYSABRI in clinical trials; and
                        • revised label and risk management plan.

                        "We are pleased that TYSABRI has received Priority Review designation, which we believe, reflects the unmet need in MS," said Burt Adelman, MD, executive vice president, Development, Biogen Idec. "We look forward to working with the FDA throughout the review process and are hopeful that we will be able to bring TYSABRI back to people living with MS."

                        "We believe that the acceptance of the sBLA for Priority Review is another step in our ongoing commitment to provide TYSABRI as a treatment option for MS patients in need," said Lars Ekman, MD, executive vice president and president, Research & Development, Elan. "We will continue to work closely with the FDA as they review the filing so that TYSABRI can be made available with an appropriate benefit-risk profile." On February 28, 2005, Biogen Idec and Elan announced that they voluntarily suspended TYSABRI from the U.S. market and all ongoing clinical trials based on reports of progressive multifocal leukoencephalopathy (PML), a rare and potentially fatal, demyelinating disease of the central nervous system. Biogen Idec and Elan recently completed a comprehensive safety evaluation of more than 3,000 TYSABRI patients in collaboration with leading experts in PML and neurology. The results of the safety evaluation yielded no new confirmed cases of PML beyond the three previously reported.
                        Last edited by jiesen; 11-17-2005, 06:12 PM. Reason: oops- didn't see that King already posted this- oh well, I'm leaving it up anyway, being such good news and all...

                        Comment

                        • spikefader
                          Senior Member
                          • Apr 2004
                          • 7175

                          Congrats on the good news dudes! I agree with jiesen though....the AH action was rather tame imo.

                          But I'm a bull! On the daily you've got a bull flag and probably a gap up tomorrow. Would be nice to see a huge volume day that will become a runaway for yall. I'd be looking for a nice bullish run to 11.50 that will make a 5th on the daily, then the abc and the c to maybe test the gap. 16.50 is very very likely after that. The really clever and patient people will buy the c long in a couple weeks. Hopefully that will coincide with a channel long and intraday pattern so I can hop on.

                          Where are my shades!

                          Comment

                          • kingofthehill
                            Senior Member
                            • Nov 2003
                            • 487

                            MORGAN STANLEY EQUITY RESEARCH

                            ELAN CORP. (ELN.N): TYSABRI GETS PRIORITY REVIEW - 17 Nov 2005 (12 pgs/ 68 kb)

                            Marc Goodman +1 (1)212 761 8403 Morgan Stanley & Co. Incorporated
                            Louise Chen +1 (1)212 761 0039 Morgan Stanley & Co. Incorporated
                            Michael Rockefeller +1 (1)212 761 6184 Morgan Stanley & Co. Incorporated

                            Quick Comment: ELN and BIIB announced after the market closed that the FDA has granted priority review status to the Tysabri sBLA for Multiple Sclerosis.

                            Our Takeaway: This is obviously positive news for ELN (and BIIB), and we believe is the main reason for the recent strength in the name. With the priority review, the two companies will remain on track to launch the drug by mid 2006 in the US, as a decision by the FDA is now expected in late March 2006.

                            The criterion for a priority review designation is unmet medical needs (e.g., underserved refractory MS patients). Thus we do not think that Tysabri’s priority review status means greater probability of an approval. With that said, we continue to believe that the drug has a very good chance of returning to the market. In addition, the designation might signal a certain favorable attitude towards the drug within the agency. Thus some may believe that the final Tysabri label might not be as bad as previously feared. However, we still believe the label will be restrictive.

                            With the stock trading above $10, we believe that the Tysabri peak sales embedded at this level are $650-700MM. If investors want to own the name now, they need to have conviction that Tysabri can be a $750MM+ drug, in our view. We continue to believe that Tysabri will not likely achieve peak sales significantly above $500MM. We won’t know until next summer.

                            Industry View: We maintain our In-Line view of the Specialty Pharma Industry.

                            Comment

                            • kingofthehill
                              Senior Member
                              • Nov 2003
                              • 487

                              Spike give me a new chart to read..Thanks

                              Comment

                              • kingofthehill
                                Senior Member
                                • Nov 2003
                                • 487

                                Sent: Friday, October 21, 2005 2:20 PM
                                To: Matthew Strobeck; Will Muggia
                                Subject: Elan/Biogen Observation

                                Dear Investors:

                                Though we are not as exposed to Elan/Biogen as we were in the past, we feel compelled to provide a quick update on Biogen Idec and Elan given two articles published yesterday in the New England Journal of Medicine. In July, three different case study articles were published in the New England Journal of Medicine on the patients (2- Multiple Sclerosis and 1- Crohn's) presumed to have succumbed to Tysabri induced Progressive Multifocal Leukoenchephalopathy (PML). Please recall that one of the Multiple Sclerosis (MS) patients (from Colorado) reportedly died from the PML infection. In response to these articles, four neurologists drafted letters to the authors and the resulting correspondence was published yesterday in the New England Journal of Medicine.

                                Interestingly, all four neurologists noted that the Multiple Sclerosis patient who died from PML, likely did not have Multiple Sclerosis. These neurologists state that after reviewing the Colorado patients history, medical records etc.. that this patient did not have MS because: 1) no oligoclonal bands were detected in two separate examinations of the cerebrospinal fluid, 2) several Magnetic Resonance Imaging (MRI) scans obtained over many years never showed enhancing lesions and 3) neuropathology unequivocally proves that no MS lesions were ever detected (the presence of these lesions are the key hallmark of the disease). Based on this, the neurologists believe that this patient from Colorado may have had a subclinical nonfatal case of PML, which was misdiagnosed as MS. Strikingly, one of the original authors of the New England Journal of Medicine case study articles concurs with the potential misdiagnosis. Thus, this patient, likely should have never been enrolled in the MS study evaluating the use of Tysabri along with Avonex. These findings also bring into question the diagnosis/underlying condition of the other patients presumed to have developed PML due to treatment with Tysabri.

                                The suspension of Tysabri on February 28 was a prudent measure by both Biogen Idec and Elan to fully assess the situation and define the risk of PML to MS patients. However, these recent findings show the inherent variability/occasional errors that occur in the diagnosis and treatment of patients. If Biogen Idec and Elan can prove that this patient was misdiagnosed (which may be highly unlikely at this point) it could significantly change the risk profile of Tysabri. In the analysis we forwarded in early March, we cited the potential for misdiagnoses based on the strong safety data seen at two years in the monotherapy study and the known MS-like effects of PML in the brain.

                                It is astonishing how the public markets can jump to conclusions and formulate opinions, which at times are just not based on hard evidence. It does not matter now since the damage has been done, but we remain hopeful that Tysabri becomes available to the patients who desperately need it and that over time these issues around PML are resolved. We fully understand that being intellectually right; yet losing money is a bad outcome. However, our investment process has not and will not change.

                                Thanks again for your support.

                                Best,

                                Will Muggia and Matt Strobeck

                                William A. Muggia
                                President & Chief Investment Officer
                                Westfield Capital Management Company, LLC
                                One Financial Center, 24thFloor
                                Boston, MA 02111"



                                *************HUGE NEWS ******** these guys owned 42 million shares of elan before the stock fell>>>>>>>>>>

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