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lws2000 281 posts  |  Last Activity: 6 hours ago Member since: Nov 21, 2001
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  • lws2000 lws2000 Mar 27, 2015 1:55 PM Flag

    The FDA has the final word in the USA about a drug being approved for use. Their ability to grant advanced approval, or normal approval "influences" other studies, and the usage of any drug in the USA. Studies outside of the USA depend on different organizations, so Imetelstat is not fully dependent on the FDA.

    Sentiment: Strong Buy

  • lws2000 lws2000 Mar 27, 2015 12:57 AM Flag

    "effect" can be a verb meaning "to bring about," "to cause," or "to achieve": He effected his escape with knotted bedsheets. You will effect these changes on Monday.

    kpail---I believe that "effected" is a proper verb here, but "affected" may be better.

  • lws2000 lws2000 Mar 26, 2015 7:31 PM Flag

    IMO, the FDA has to grant advanced approval in the near future, because there are no negatives, and only positives (live saving, unique, needed, remissions). The FDA is a reasonable and honest group, that puts patient's needs first.

  • lws2000 lws2000 Mar 26, 2015 2:03 PM Flag

    Thank you--"Though "cite, site, and sight" were confused before the Internet, we are more likely to use "site" for all of them because we use it so often for "Website". If you can remember "cite" is short for citation and "site" is a location, whether it's online or off, you'll have the "sight" to use the words correctly."--current thinking

    "sight" can also mean "find" or "view".

  • I fully expect JNJ to be able to prove to the FDA that IMET is worthy of advanced approval. In addition, considering the "reach" of telomeres in the survival of cancer cells and immortal cells, I believe that there will be tests and trials in many parts of the world using IMET alone or in combination with other drugs. The FDA is important, but they are not the only game in town.

    JNJ/Janssen is an international pharmaceutical company, with partners all over the world. It has been stated that the telomere-telomerase interaction (IMET) is important in 90% of all cancers. (Why not 100%?) We know about the AML project in Australia. There must be others that are getting off the ground. Can anyone sight some incipient studies?

  • lws2000 lws2000 Mar 26, 2015 10:00 AM Flag

    JNJ/Janssen is an international pharmaceutical company, with partners all over the world. It has been stated that the telomere-telomerase interaction (IMET) is important in 90% of all cancers. (Why not 100%?) We know about the AML project in Australia. There must be others that are getting off the ground. Can anyone sight some incipient studies?

  • lws2000 lws2000 Mar 25, 2015 12:42 PM Flag

    Hi Black: I have started to look. We know about AML research in Australia. The EHA (June 11 to 15) will be another place of interest. The FDA is in a "relaxed mode" at the moment, but that could change. Janssen/JNJ could go anyplace in the world, that seemed worthwhile.
    ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
    Event Description

    EHA 2015, 20th Congress of European Hematology Association (EHA) is scheduled between 11 June, 2015 and 14 June, 2015.

    The Congress place is going to be Messe Wien Exhibition & Congress Center.

    EHA 2015 is a place where numerous valuable scoop are discoursed. These are going to be Hematology, Medical, Health and Pharmaceutical.

    This Congress is forecasted to be visited by nearly 10000 professionals.

    20th Congress of European Hematology Association (EHA) is organized annually.

  • The "Veil of Silence" is being strictly enforced by JNJ/Janssen, as they reach out to the FDA for the "new-go-ahead" rules. There will be plenty of time for shouting about IMET's miracle properties. The FDA approval is critically important in the USA, and no medicine can succeed without its approval here. Outside of the USA it is a different story. We have seen drugs approved for use in Europe, before they were granted approval in the USA.

    "Tantamount to a Cure" is a description of Imetelstat (IMET), that was coined in 2014, and they still fully support. Considering Mayo Clinic's history and outstanding reputation, there can be no question about IMET's remissions and life saving properties in MF and beyond (MDS, AML, etc.).

  • Reply to

    Surprise!!!

    by blackmarango Mar 23, 2015 10:28 PM
    lws2000 lws2000 Mar 25, 2015 10:47 AM Flag

    The "Veil of Silence" is being strictly enforced by JNJ/Janssen, as they reach out to the FDA for the "new-go-ahead" rules. There will be plenty of time for shouting about IMET's miracle properties.

  • lws2000 lws2000 Mar 25, 2015 12:32 AM Flag

    There is never any bad news reported about IMET, so the science and medical successes are still intact. It will take a medical setback, on the safety side, to disrupt IMET, and that does not seem likely at this point in time. The PPS of Geron follows its own path, which is additionally tied to investor psychology, and hedge funds.

  • lws2000 lws2000 Mar 24, 2015 2:47 PM Flag

    Maine---I was born Feb. 3, 1936. I believe the IMET story, and I believe in what Mayo says about it. I see no reason to question their successes, and find "Tantamount to a Cure" a very concise summary of their work to date. That "horse" is not old or tired, and will not die (immortal cells & controlled telomeres). That is my opinion, from the evidence that is in the public domain. Cancer may not be completely cured for a very long time, but I am reasonably sure that IMET is one of the important building blocks in finding remissions and a partial cure now.

  • Imetelstat (IMET) has already succeeded (remissions that are unique with a high level of safety). The FDA and JNJ both know this. Patient's needs have to come first, but, so far, they have been short-changed. That cannot persist. The "surprise" will be a "silence-reversal" from both the FDA and JNJ/Janssen Biotech, that will bring IMET into the news, and reignite "Tantamount to a Cure" (from Mayo Clinic), as a guiding light.

  • Reply to

    Surprise!!!

    by blackmarango Mar 23, 2015 10:28 PM
    lws2000 lws2000 Mar 24, 2015 8:34 AM Flag

    As far as I can tell, BlackMarango has supported IMET as a "remarkable drug", but has blamed Dr. S for the low PPS, and the "Veil of Silence". IMO, JNJ is now running the show (due to Dr. S) and requires this "Veil of Silence" until the FDA is onboard. IMET is safe, brings remissions, saves lives and is needed now. That is all that the FDA requires for advanced approval.

  • Reply to

    Surprise!!!

    by blackmarango Mar 23, 2015 10:28 PM
    lws2000 lws2000 Mar 24, 2015 12:27 AM Flag

    I think you are correct. I have suspected for awhile that JNJ and the FDA were close to working out the problems of advanced Imetelstat (IMET) approval, that the management at Geron could not work out alone, for a variety of reasons. IMET as a medicine seems to have passed all of the required tests.

  • lws2000 lws2000 Mar 23, 2015 8:17 PM Flag

    The basis for moving over $5 is in the quality of Imetelstat. IMET looks good with no significant negatives, and many positives (safety, remissions, combination therapies, needed now). $5 should have been achieved and surpassed awhile back, with the JNJ partnership and the FDA removal of the low-level-liver-holds. The FDA seems to have every good reason for an advanced-approval for IMET now. Some have said that administratively Geron messed-up, and needed both Mayo Clinic (MF data) and JNJ (proper filing procedure) to bail them out. That process has not been completed, but patient's welfare will eventually come first.

  • According to the warning, two of Gilead's Hepatitis C drugs, Sovaldi and Harvoni, may have adverse reactions when mixed with amiodarone, a drug that treats heart rhythm problems.

  • lws2000 lws2000 Mar 22, 2015 12:24 PM Flag

    There seems to be nothing that we know about that can stop IMET (no significant negatives, and a major part in finding a cancer cure). Geron's PPS should follow, and the FDA has every reason to grant advanced-approval (remissions, safety, combination therapy).

  • Reply to

    FDA Advanced Approval Seems in the Cards

    by lws2000 Mar 18, 2015 4:30 PM
    lws2000 lws2000 Mar 20, 2015 3:39 PM Flag

    Mayo Clinic's successes are real. "Tantamount to a Cure". Geron must have little credibility, since they appear to have one of the secrets in creating cancer remissions, that can be enhanced in combination with other drugs. The science and medical remissions all look honest, with great potential going forward. The FDA knows all of this. My belief is that it will all work out for the better, but the manipulations are not easy to stomach (see Washington Post article, Sep. 2014).

  • Reply to

    FDA Advanced Approval Seems in the Cards

    by lws2000 Mar 18, 2015 4:30 PM
    lws2000 lws2000 Mar 20, 2015 2:34 PM Flag

    Everything you say is true. Still I believe that Geron and Imetelstat (IMET) could not get around the barriers, either of their own making or by an FDA that was influenced by others (liver-holds, etc.). Geron eventually figured out that they needed a partner that knew how to deal with the FDA. JNJ/Janssen and Mayo Clinic should get IMET & GERN over the finish line sooner or later.

  • Reply to

    FDA Advanced Approval Seems in the Cards

    by lws2000 Mar 18, 2015 4:30 PM
    lws2000 lws2000 Mar 19, 2015 9:22 PM Flag

    After thinking about it, I believe, that the slowest of FDA approval has come about, because Geron was overwhelmed by the successes of IMET at Mayo Clinic, and how to handle good data that they did not own (Mayo's MF data). JNJ/Janssen knows how to interact with the FDA (numerous advanced approvals), so these administrative problems should be gone by now. Dr. Tefferi is now working closely with Janssen, while retaining his position at Mayo. IMET and blood cancer patients will be the winners. The evidence in favor of IMET looks overwhelming, and advancing the use of IMET is now a team effort (Janssen-Mayo-Geron).

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