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lws2000 201 posts  |  Last Activity: Jul 8, 2014 8:04 PM Member since: Nov 21, 2001
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  • Some people believe that Geron's reputation is tainted, its management is flawed, and took profits today. Still, Mayo's continuing successes cannot be denied, and the FDA seems to be listening to Mayo with great interest (hold modification). Mayo is in control, and the stock will move higher next week. (IMHO over $4.00).

    The liver-factor turned out to be a nonevent, so there is nothing left to hold this drug back. Good medicine, just out of reach of dying patients, makes no sense, and the FDA is in the process of correcting that mistake.

  • The hold will be modified or lifted by May 15. Mayo and the FDA are working together in the best interests of the patients in the Mayo Clinic studies. Both organizations are honest and seek transparency. The conclusion will be that Imetelstat is unique, effective and safe with proper dosing considerations and follow-up testing for possible side-effects. This is based upon available information and commonsense. Geron. of course, will benefit.

  • This is a contest for the ages, and a good subject for a PhD thesis. There are numerous subplots here. IMO, the "Miracle Drug" ultimately dominates, but the market control has been amazing. There seems to be something unusual going on, that is beyond normal market interactions. Mayo has told the whole world, loud and clear in their current brochure, that Imetelstat is the "real-thing". The FDA has to be listening, and has no reason to oppose Mayo's very carefully acquired results in their MF trials and studies.

  • Reply to

    John Mayo Visit

    by irishtrader52 Apr 21, 2014 5:01 PM
    lws2000 lws2000 Apr 22, 2014 10:31 AM Flag

    "John" seems to be model for everything that is positive and promising about Imetelstat. The last line (from Irish) is very encouraging: "Liver function tests all normal: Bilirubin (total and direct or conjugated and unconjugated is normal. ". This would indicate that the " FDA-hold" is about to disappear.

  • By Brady Dennis and Ariana Eunjung Cha, Friday, May 16 (Washington Post excerpt)

    Colorado, Missouri and Louisiana are poised to become the first states in the nation to give terminally ill patients the right to try experimental drugs without the blessing of the Food and Drug Administration, setting the stage for what could be a lengthy battle over who should decide whether a drug is too risky to try.

    Lawmakers in the three states have passed “Right to Try” laws with unanimous votes in recent weeks, after high-profile, social media campaigns in which families of dying patients have pushed for access to unapproved but potentially lifesaving drugs. Colorado’s governor is expected to sign that state’s law Saturday.

    Proponents of the measures argue that patients desperate for treatments must navigate a lengthy, cumbersome process to get the FDA to approve early access to experimental drugs and to persuade companies to provide them. The Right to Try laws are intended to cut through some of that red tape by essentially cutting the federal government out of the picture.

    “For people who are facing death and have one last hope, they should have a choice to try every possible drug,” said state Rep. Joann Ginal, a Democrat and co-sponsor of the bill in Colorado. Ginal introduced it in part because she witnessed how an experimental treatment helped her older brother, who has a rare blood cancer.

  • I believe that when Geron switched its emphasis from hESC to Imetelstat, they thought they had a good product that could be brought to market in a reasonable time. Mayo Clinic's success has gone far beyond what Geron thought possible. Mayo now controls the continuing clinical trials, the relationship with the FDA, and has a vested interest in Imetelstat. Geron is really in a very strong position, since Mayo it trusted by all. In addition, Geron is not totally out of the stemcell business (distributions, cancer stemcells, etc.).

    Sentiment: Strong Buy

  • lws2000 lws2000 Jul 8, 2014 8:04 PM Flag

    JUST REMEMBER: "Tantamount to a cure". This is a solid review, and it is all positive. The world is listening, and the FDA is listening. Nobody has any significant negatives (medicine & science).
    ***********************************************************
    FROM MAYO BROCHURE:

    At Mayo Clinic, discoveries happen every day. We focus on the needs of the patient, which require that our research model addresses patient-centered, patient-inspired discoveries.

    STOPPING HEMATOLOGICAL CANCER: New Drug Induces Remissions in Myelofibrosis

    The results of a Mayo Clinic study demonstrate that a drug named imetelstat induces remissions in some patients with myelofibrosis. This is a form of chronic leukemia that affects the patient’s bone marrow that is replaced by fibrosis (scar tissue) instead of blood-producing cells.

    Scientists do not yet know the exact mechanism of action for imetelstat, but believe it interferes with the survival and proliferation of cancer cells by inhibiting a critical enzyme called telomerase. One of the functions of telomerase is to repair the ends of chromosomes called telomeres, and because cancer cells have shorter than normal telomere size, they are particularly susceptible to the drug.

    The study results are promising. Some patients participating in the clinical trial taking imetelstat obtained dramatic responses, and we have seen some complete responses (tantamount to a cure), which is almost unheard of in this disease.

    Although patients may experience relief in response to other treatments, their bone marrow does not usually return to normal. But in the case of this new therapy, some of the patients participating in the trial developed normal bone marrow.

    Researchers studied imetelstat in 33 patients at Mayo Clinic and have now followed the first 22 patients for more than six months. Among these 22 patients, two achieved complete remissions and three partial remission, including reversal of bone marrow fibrosis in four of the five.

  • Reply to

    John Mayo Visit

    by irishtrader52 Apr 21, 2014 5:01 PM
    lws2000 lws2000 Apr 22, 2014 12:55 PM Flag

    This is the kind of information that would propel this stock higher. The FDA has no reason to keep the "hold". This is Irish-News.

  • Geron Set To Explode As FDA Releases Partial Clinical Hold On Imetelstat Myelofibrosis Trial by Stock Doctor
    This article was published on Mon, Jun. 30, 10:47 AM ET (Seeking Alpha)

  • lws2000 lws2000 Jun 19, 2014 2:54 PM Flag

    To "protect####"----end2war is one of the most knowledge and informative members on this board. Please do not insult the "good guys", and post less frequently. Mayo is the driving force behind the success of Imetelstat. They also have long term, respected and trusted relationships with the FDA. Geron is happy to let Mayo do the heavy lifting. As Mayo succeeds, Geron will be close behind (perhaps a few weeks or a few months). This is the perfect situation for Geron, as they observe progress from a distance.

  • Each new presentation brings forward more good news about Imetelstat. The "hold" is running out of steam as the evidence continues to built positively about the safety and effectiveness of Imetelstat. Thursday will be another good day.

  • No one has said anything about the Mayo clinical trials ( using Imetelstat) that have shown dangerous, unwelcome results. If "Damming Data" did exist we would have heard about it by now. Irish (patient input), Tefferi (Mayo input), and Scarlett (Geron input) would have shown some unhappiness with the results, yet the opposite seems to be true.

    There are no conspiracies here, IMO. The FDA (overly cautious, slow, bureaucratic, perhaps influenced by some lobby) will soon get their act together, and back Mayo. Imetelstat appears to be effective and safe with healing properties that no other treatment offers. The hold will vanish, but the day is totally uncertain. My "pure conjecture" is before May 15.

  • lws2000 lws2000 May 6, 2014 9:58 AM Flag

    Of course it is only temporary. SA article also says you must be in the stock now, because when the hold is modified (as they say) there will be an instant triple. That could happen next week.

    It is now obvious that no patient has quit treatments with Imetelstat because of liver problems, and some treatments have continued for more than 3 years (Scarlett & SA). The FDA has been "dutifully cautious" and has no reason to continue the hold in its present form. Mayo Clinic holds the data, patients and good medical sense. Geron, Mayo and the FDA are on the same page, and it all appears good for Imetelstat and the cancer patients.

    Sentiment: Strong Buy

  • The drug works, and is very effective and very safe (for a cancer drug). All of the information from the Merrill-BAC Health Conference was positive. No negatives appeared. The market cap is ridiculously low, but that will soon change. The FDA has no reason to continue the "hold", but the release date is not known. Meanwhile, the large institutions appear to be acquiring the stock. Mayo is trusted, and fully supports Imetelstat.

  • Reply to

    Price will not increase until December

    by hairypotter9 Jun 4, 2014 3:59 PM
    lws2000 lws2000 Jun 4, 2014 6:22 PM Flag

    That the conventional thinking, but I believe you are wrong. Mayo and the FDA are on the same page, since low-order liver observations are not a problem, especially where there is a medical need. Geron is likely to POP this month.

  • Reply to

    How in god's green earth....

    by uvainvestor82 May 15, 2014 11:44 PM
    lws2000 lws2000 May 16, 2014 12:24 AM Flag

    You have answered the question. The drug works, and is very effective and very safe. All of the information from the Merrill-BAC Health Conference was positive. No negatives appeared. The market cap is ridiculously low, but that will soon change.

  • Reply to

    Hold to be Modified by May 15, 2014 (opinion)

    by lws2000 Apr 16, 2014 12:49 PM
    lws2000 lws2000 Apr 16, 2014 8:28 PM Flag

    I have rethought this from the several points of view expressed on this board. I still think its Mayo's game. Mayo is very pro-Imetelstat, and will have the most important say (their patients, their doctors, their data, their trials, their good medical sense).

    The FDA is totally dependent on Mayo's clinical trials, their analysis, and their scientific understanding. Geron ceases to exist, if Mayo turns negative about the use of Imetelstat. So far, no one has said that there is anything dangerous (in the relative sense) about the use of this drug. No other drug is in its league (CR, PR, CI, potential cures). The hold is coming off soon. I still think that time period is less than a month. The hold was probably an unnecessary and a poor call by the FDA.

  • lws2000 lws2000 May 10, 2014 9:45 AM Flag

    Patients' immediate need is the most overwhelming argument. The safety appears proven (over 3 years, including liver) and the effectiveness has been shown in the Mayo studies. Remissions are unique to Imetelstat with potential cures. I would not be surprised by an FDA positive statement by the end of May (perhaps next week) since nobody has presented any negative information (does not exist) concerning Imetelstat. The dosing considerations are well understood now.

    This is the same story over and over again. A great medicine with minimal side-effects trumps all other considerations. Mayo, Geron and the FDA are on the same page (benefit to the cancer patients). May 15 (Merrill, Bank of America Health conference) is the next date of interest.

  • Reply to

    Imetelstat's Transition to an Accepted, Safe Drug

    by comsensea Jun 11, 2014 10:52 AM
    lws2000 lws2000 Jun 11, 2014 11:58 AM Flag

    It appears that the "word" has been leaked, about the future status of the so-called HOLD. The HOLD never existed for Mayo because their trials continued unimpeded, with full and complete testing at all times (read the "Irish-Reports").

  • At Mayo Clinic, discoveries happen every day. We focus on the needs of the patient, which require that our research model addresses patient-centered, patient-inspired discoveries.

    STOPPING HEMATOLOGICAL CANCER: New Drug Induces Remissions in Myelofibrosis

    The results of a Mayo Clinic study demonstrate that a drug named imetelstat induces remissions in some patients with myelofibrosis. This is a form of chronic leukemia that affects the patient’s bone marrowthat is replaced by fibrosis (scar tissue) insteadof blood-producing cells.

    Scientists do not yet know the exact mechanism ofaction for imetelstat, but believe it interferes with the survival and proliferation of cancer cells by inhibitinga critical enzyme called telomerase. One of the functionsof telomerase is to repair the ends of chromosomes called telomeres, and because cancer cells have shorter than normal telomere size, they are particularly susceptibleto the drug.

    The study results are promising. Some patients participating in the clinical trial taking imetelstat obtaineddramatic responses, and we have seen some complete responses (tantamount to a cure), which is almost unheard of in this disease.

    Although patients may experience relief in responseto other treatments, their bone marrow does not usually return to normal. But in the case of this new therapy, some of the patients participating in the trial developed normal bone marrow.

    Researchers studied imetelstat in 33 patients atMayo Clinic and have now followed the first 22 patients for more than six months. Among these 22 patients, two achieved complete remissions and three partial remission, including reversal of bone marrow fibrosisin four of the five patients.

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