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Deutsche Telekom AG Message Board

lws2000 4577 posts  |  Last Activity: 1 hour 29 minutes ago Member since: Nov 21, 2001
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  • 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 1 hour 55 minutes ago
    lws2000 lws2000 1 hour 35 minutes ago 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 2 hours 27 minutes ago
    lws2000 lws2000 1 hour 57 minutes ago 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

    Chippy

    by blackmarango 20 hours ago
    lws2000 lws2000 2 hours 51 minutes ago 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.

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

  • Reply to

    Chippy

    by blackmarango 20 hours ago

    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

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

  • 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

    TUG OF WAR

    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?

  • lws2000 lws2000 Feb 24, 2015 4:00 PM Flag

    BlackM**--It seems to me that a breakout for Geron's PPS is coming. Although I know very little for sure, I can't see anything holding IMET back for very long. You may be correct about the lack of a formal filing with the FDA (for unknown reasons), but, if so, JNJ should be able to remedy that shortcoming. There seems to be no "black-data" concerning IMET that has yet to be revealed, because of your famous "Veil of Secrecy". The AACR (America Association of Cancer Research) cancer program looks like it will be attended by the JNJ-Mayo-Geron team, but the format is presently unknown. It sounds like the right forum for IMET.

  • lws2000 lws2000 Feb 24, 2015 11:40 AM Flag

    Imetelstat (IMET)=Telomeres and Telomerase=Geron's only "game"=JNJ's global interests=(MF, MDA, AML) blood cancer patients=Mayo Clinic's ("Tantamount to a Cure).

    The JNJ/Janssen-Mayo-Geron team will be there in their fineness Sunday attire. Does anyone know the "5 cancer types"?

  • lws2000 lws2000 Feb 23, 2015 11:53 PM Flag

    BlackM--"forcing their hand" is a term that means: If IMET is approved and used successfully in other parts of the world, the FDA would know about it, and get pressure from various sources (media, medical people, etc.). The FDA would not be literally forced to do anything, but they would look ridiculous.

  • lws2000 lws2000 Feb 23, 2015 8:58 PM Flag

    The point is that IMET can be approved, sold and used outside of the USA, especially with JNJ's global presence. The FDA would certainly be aware of use outside of the USA.

  • I believe advanced-approval is coming from the FDA, because IMET (telomeres and telomerase) is an exceptional drug (saves lives, unique, safe, remissions, etc.), but keep an eye on Australian and the AML tests. IMET may get approved outside of the USA before the FDA acts, thus forcing their hand.

    I think IMET, with JNJ and MAYO Clinic as advocates, looks like the "real-deal" , and will get FDA advanced-approval, when we all (long investors) are ready to give up (maybe tomorrow, maybe in 3 months), but I believe it is coming. More important, trials are now being conducted outside of the USA (AML in Australia with another drug in combination with IMET, for example), so FDA approval could become relatively less important, and perhaps totally irrelevant.

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