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lws2000 282 posts  |  Last Activity: Feb 28, 2015 6:09 PM Member since: Nov 21, 2001
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  • No Significant Negatives (for IMET)=Advanced Approval from the FDA

    The only reason to be a long term investor in Geron (as I am) is the belief in IMET as a "remarkable, needed, remissions creating, tantamount to a cure, safe, effective, life saving" medicine that has been shouted about from the roofs of Mayo Clinic and Geron (but few are listening), plus all of the important healthcare conferences in the USA (starting in 2014, then with ASH-2014, and continuing into 2015). All of the blood cancer cousins look like they respond positively to IMET's magic (MF, AML, MDS, etc.). No one has said otherwise.

    The final arbiters are JNJ and the FDA, with advanced-approval coming from their closed-secret meetings in the near future (as I see it). IMET has met all of the criteria for advanced approval, which is for a valuable drug with no significant negatives to bring hope, improvement, and cures long before the traditional time it takes to complete phases 2 & 3. This is a safe drug, so nothing can be lost, and there is everything to gain.

  • Reply to

    Results vs Reason to worry

    by woofs_a_lot Feb 17, 2015 11:45 AM
    lws2000 lws2000 Feb 28, 2015 11:34 AM Flag

    IMET will stand or fall on its own merits, with JNJ and the FDA being the final arbiters in the USA. Other countries are now an important factor. Human nature has criminal and corrupt components that only good regulations and strong enforcement can control. IMET, as a remarkable drug, will rise above all of that.

  • Reply to

    Results vs Reason to worry

    by woofs_a_lot Feb 17, 2015 11:45 AM
    lws2000 lws2000 Feb 28, 2015 9:42 AM Flag

    The medical and scientific results are on IMET's side. Medical reasons for FDA advanced approval are on IMET's side. There is a crime and corruption factor in the market place that may be a factor in controlling the PPS, but there are only suspicions (interesting topic). JNJ and the FDA will come to the right decision, based upon IMET's quality, need, safety, and effectiveness; IMET gets very high marks in all 4 categories. Geron's PPS will explode one day, which IMO, will be soon, but no one (without inside information) can give a date, as the closed discussions continue.

  • Reply to

    The Data?

    by blackmarango Feb 27, 2015 10:09 AM
    lws2000 lws2000 Feb 27, 2015 5:03 PM Flag

    There is nothing wrong with the data that we have seen from Mayo Clinic in their MF trials in humans. More data is coming in the USA and from other countries. There is every reason to believe that additional data will be good, and it will extend to other blood cancer cousins (MF, AML, MDS, etc.). We certainly will have results in phase II (a long time), but there should be advanced approval now (patients' needs), considering the quality and successes of the Mayo trials.

    I know your arguments about an incompetent Dr. Scarlett and a bungled application or lack there of. JNJ is now leading the team (JNJ-Mayo-Geron) and discussions with the FDA. Either IMET is a very good medicine, or there has been some sort of hoax. I choose to believe the former (very good medicine), with the FDA in full agreement. No one has suggested otherwise about IMET.

  • lws2000 lws2000 Feb 27, 2015 1:25 PM Flag

    No one on this board knows of any significant negatives concerning IMET, which is safe and saves patients' lives. JNJ and the FDA will get it right (Advanced-Approval). The FDA, as part of our gridlocked government, is slow to act (homeland security, for example), but they are not corrupt, IMO.

  • There is every reason for the FDA to grant advanced approval now, since there are no lingering safety issues (ill conceived liver holds are gone).

    It is JNJ-Mayo-Geron, as a team, strong in IMET experience, practical oncology, conducting trials, collecting proper data, and in influence with the FDA (all together) that guarantee advanced approval for IMET very soon (don't know when, but soon). The FDA and the "team" put patients' needs first.

  • Reply to

    What we know so far

    by carl0s_mr Feb 27, 2015 10:41 AM
    lws2000 lws2000 Feb 27, 2015 11:01 AM Flag

    It is JNJ-Mayo-Geron, as a team, strong in IMET experience, practical oncology, conducting trials, collecting proper data, and in influence with the FDA (all together) that guarantee advanced approval for IMET very soon (don't know when, but soon). The FDA and the "team" put patients' needs first.

  • Reply to

    The Data?

    by blackmarango Feb 27, 2015 10:09 AM
    lws2000 lws2000 Feb 27, 2015 10:38 AM Flag

    I am hoping that there are now being conducted or will be shortly initiated more human trials in the blood cancer cousins (MF, AML, MDS) in the USA (advanced approval & phase II), and around the world (as you suggested). We know about Australia (AML), plus Israel, Asia and Europe are always possibilities. The FDA has an important say, but they should not have the only say about "a remarkable drug". New data from new and continuing trials, I believe, will be some of the updated news that is coming soon. JNJ-Geron-Mayo certainly has more of a global presence than Geron floundering alone.

  • Reply to


    by blackmarango Feb 26, 2015 4:29 PM
    lws2000 lws2000 Feb 27, 2015 9:44 AM Flag

    BlackM----I see it a little differently (continuing events, all with updated news). All that has to be done is to keep repeating the "old good news", with positive forward looking updates at these multiple health conferences. That is happening, so the IMET message (a remarkable drug) has to be more widely understood as being the real-deal. The PPS has to follow, even through, some market innovators know how to control the PPS, for the moment.

  • lws2000 lws2000 Feb 26, 2015 4:54 PM Flag

    Someday, soon, the whole world will realize that IMET is a "remarkable drug" and the "real deal".

  • Reply to


    by blackmarango Feb 26, 2015 4:29 PM
    lws2000 lws2000 Feb 26, 2015 4:47 PM Flag

    What can he tell you that we both do not know? IMET is the real-deal, and should have immediate FDA approval. There is a "Veil of Secrecy" (for whatever reason) that the JNJ-Mayo-Geron team has chosen as discussions continue. If there are "administration, paper-work" problems they are being "fixed". I, for one, have no problem with closed meetings. Advanced-Approval should have happened yesterday.

  • Reply to

    Back to $40

    by nom_de_plune Feb 24, 2015 5:03 PM
    lws2000 lws2000 Feb 26, 2015 3:14 PM Flag

    I agree: (1) Defense (2) Healthcare (3) Consumer (4)Space. The "3rd Industrial Revolution" is just starting, and intelligent robots are the future.

  • lws2000 lws2000 Feb 26, 2015 2:54 PM Flag

    The talks for FDA-advanced-approval are secret, as they should be. Can there be anymore doubt about the good features, and lack of bad features concerning IMET? It creates full remissions MF (humans) and in the other blood cancer cousins (MDS, AML, etc.), it probably cures some cancers (too soon to tell for sure, "tantamount", 5 years), it is as safe as a cancer drug can be, it saves lives, Mayo Clinic says this is a "remarkable drug" that patients need now. IMET is the real-deal.

  • Any lingering administrative problems are now being addressed and put to rest by the FDA and JNJ. Both put the patients' interests first.

  • Reply to


    by lws2000 Feb 26, 2015 9:57 AM
    lws2000 lws2000 Feb 26, 2015 11:39 AM Flag

    The Pros for the Science and Medicine (S&M) side should overwhelm the Hedge Funds and the Shorts. No body has come up with a single negative on the (S&M) side to counter the good reports from Mayo Clinic (MF); that is a safe, effective, unique medicine, with huge potential in the blood cancer cousins (MF, AML. MDS, etc.), plus promise in all telomere related situations (cancer stem cells, solid tumors, aging, immortal cells, etc.). The FDA knows that, and is about to pull (S&M) across the victory line. JNJ and the FDA are now in secret discussions, which, because of the brilliant (S&M), can only end very positively for the patients and IMET believers.

  • lws2000 by lws2000 Feb 26, 2015 9:57 AM Flag

    Science and Medical Successes VS. Hedge Funds and Shorts

  • lws2000 lws2000 Feb 25, 2015 9:19 PM Flag

    Advanced-approval is coming because no one in the medical community is against IMET, that I can find. The FDA is not in opposition to IMET, and has Mayo Clinic 100% in support of advanced-approval. The FDA has no medical or scientific reason to oppose or question IMET, at this point in time. If there is some paper-work-administrative-problem (as BlackM suggests), JNJ and the FDA (well known to each other) can easily work it out. IMET is a "remarkable drug".

  • lws2000 lws2000 Feb 25, 2015 11:56 AM Flag

    Of course that is the purpose of advanced-approval: to get a good, safe, life saving drug (all evidence pointing in that direction for IMET) on the market ASAP before a complete testing is finished (phases 2 & 3 are very time consuming). Phases 2 & 3 will happen, but lives will be saved now. Everyone wins (patients, long term investors, FDA, researchers).

  • lws2000 lws2000 Feb 25, 2015 11:32 AM Flag

    (Black---)--Aren't we saying the same thing? You say, " FDA only considers, for Fast Track, applications THAT HAVE BEEN SUBMITTED". I try to counter some of your views, but we both agree that IMET is "a remarkable drug", that deserves FDA advanced-approval now.

    Either it has been applied for, or the application is being prepared. Either way, IMET comes out on top. The only question is when (tomorrow, next week, next month, later in the year, longer?). I believe a shorter-time frame will prevail, because "remissions, plus safety & need" are unique to IMET ("Tantamount to A Cure"). The FDA is the key, but it is part of our government, which is subject to gridlock and crony-corruption (unpredictable, like homeland security). You believe that Dr. Scarlett is the problem (I don't agree completely, but he made some early mistakes), plus he now has Mayo Clinic and JNJ as partners to avoid any future mistakes.

  • I believe that IMET is already a successful drug, that has been tested with outstanding results (MF in humans) at Mayo Clinic as "a remarkable drug" (remissions, unique, safe, effective, huge potential). JNJ/Janssen apparently sees the same thing. The FDA is now getting properly prepared data from Mayo Clinic/Geron, with Dr. Tefferi on both staffs. JNJ has almost infinite experience in dealing with the FDA, and is now a guiding light (new partner). Telomeres and Telomerase are prime building blocks in the quest (cure for cancer).

    My only worry is that somehow, I am wrong about IMET (no evidence of that, so far), and it is not the "remarkable drug" that I think it is, Mayo thinks it is, and JNJ thinks it is. What is wrong with the FDA (ill conceived liver-holds that are now gone, influenced by the wrong people that have never had remissions, etc.)?

    It seems to me, with all of the recent advanced-approvals (including some with JNJ), IMET should be high on the FDA's list for advanced-approval. What am I missing? My conclusion (with all of the positive health conferences, and global trials now starting) IMET is a "slam-dunk" (science and medicine), with FDA advanced-approval very close, and worth waiting for. The short-hedge-funds cannot keep "a remarkable" drug down for much longer.

    Does anyone disagree?

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