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Geron Corporation (GERN) Message Board

scistats 194 posts  |  Last Activity: Apr 13, 2014 2:43 AM Member since: Apr 5, 2009
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  • If you spent the weekend reading Irish's posts, you are probably a believer.

    You are here to watch Imetelstat through. Maybe not forever, but long enough to expand a chart and see the dip of 2014 as a ripple on the horizon, barring armageddon of course.

    You may perish, but if you survive, there will be a reward for using the market for what it was meant to be used for. Not to conduct politically condoned gaming of the system, domestically, offshore, at a law office, or from behind a Seeking Alpha, Motley Fool, The Street, or Jim Cramer pseudo media scam.

    So, risk only what you can afford to lose, ignore the blogs, stay diversified, don't try to time the market, and maybe one day you will be the Secret millionaire who donates a fortune, like the famous Lake Forest College alumna.

    Cheers to those who look forward to earning a return by putting products on the shelves and accepting the risk to bet we can do it. May those who game other peoples labor for their own profits rot in hell.

    Sentiment: Strong Buy

  • Reply to

    Florence Miami Conference 2

    by irishtrader52 Apr 12, 2014 1:24 PM
    scistats scistats Apr 12, 2014 10:10 PM Flag

    Many thanks Irish.

    Sentiment: Strong Buy

  • Computer algorithms turn from HFT to sophisticated, coordinated manipulation.
    Enjoy!

    Sentiment: Strong Buy

  • Drugs for the dying: Compassionate use
    By Elizabeth Cohen, Senior Medical Correspondent

    Imetelstat is compassionately curing...you can't beat that!

    Sentiment: Strong Buy

  • Reply to

    WS Dogs Are Doing It Again!

    by mruyog Apr 2, 2014 12:58 PM
    scistats scistats Apr 2, 2014 1:18 PM Flag

    I concur.

    Sentiment: Strong Buy

  • "Pending 12-week durability assessment:
    1One patient who met the PR criteria on 4/30/2013 and converted to CR on 10/9/2013 (Arm A)
    2One patient who met CI-by Liver Response on 10/14/2013 (Arm B)"

    So one patients achieved clinical improvement (CI) by improved liver size based on palpation (see #3 below)!
    This is very interesting in that the SIZE of the liver was reduced by Imetelstat. I wonder if this size reduction would cause liver enzyme levels to alter, even though there is improvement?

    Things to remember:
    #1 Myelofibrosis causes impaired bone marrow hematopoiesis shifts blood production to spleen and liver (palpable splenomegaly in up to 80%2 of patients)
    #2 Imetelstat has a long half-life in bone marrow, spleen, liver (estimated human t½ = 41
    hr with doses 7.5 – 11.7 mg/kg)
    #3 Imaging studies were not performed for assessment of the spleen response endpoint;
    spleen and liver assessments were by palpation only

    To get to the presentation Google: Geron-ASH2013-Investor-Event

    Sentiment: Strong Buy

  • Hepatic Impairment
    Ibrutinib is metabolized in the liver and significant increases in exposure of ibrutinib are expected in patients with hepatic impairment. Patients with serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) ≥ 3.0 x upper limit of normal (ULN) were excluded from IMBRUVICA clinical trials. There is insufficient data to recommend a dose of IMBRUVICA in patients with baseline hepatic impairment.

    Sentiment: Strong Buy

  • MM, start at minute 6.

    Sentiment: Strong Buy

  • scistats scistats Mar 29, 2014 4:13 PM Flag

    Doc's have cussed and discussed since the dawn of time.

    Cussing and discussing is a way of life, and it has been going on well before Dr. Ignaz Semmelweis was scorned for even suggesting that expecting mothers were being infected by the doctor's own hands during child birth, often resulting in the death of the mothers by a common bacteria called Streptococcus pyogenes.

    What we have here is healthy discourse between medical colleagues that should be lauded and debated with facts, statistics, empirical experience, and huge doses of prophylactic gut insight. However, at the end of the day, the truth must ultimately be decided by a well designed, multi-center clinical trial, or two or three.

    Our question is: Is Dr. Tefferi taking the correct side in this argument? There is a right and wrong and plenty of gray here as well, but the market either goes up and down, and either patients are CR or PR or not. These are binary events.

    I would say that deep inside Tefferi, he knows that Imetelstat will ultimately be combined with Jakafi and/or other meds as has been demonstrated recently in pancreatic cell cultures, but he also knows that if he takes this position now, Imetelstat will be politically terminated and buried in an unmarked grave.

    I think Dr. Tefferi knows what has to be done to break the chains of politics and make progress, and he is demonstrating the stark difference between the CR's of Imetelstat and the mostly covering up of symptoms by Jakafi, which is the 400 lbs. gorilla that does not want to give anyone else any room.

    Dr. Tefferi believes in Mayo's histopathology, and his colleagues ability to distinguish the benefits of Imetelstat. He believes it is healing patients with manageable side effects. Now whether the FDA agrees with Mayo's lab results and Dr. Tefferi is another story, but really the MD's running the lab would blow a whistle if they saw warning signs, so keep this in mind.

    Sentiment: Strong Buy

  • Reply to

    My hopes for the April 12th presentation

    by sdrawkcabeman Mar 29, 2014 4:50 AM
    scistats scistats Mar 29, 2014 2:47 PM Flag

    Vette,

    REMS: Risk Evaluation and Mitigation Strategy.
    This is the FDA's purview.

    This is an example of what the FDA can do:

    Lets look at rosiglitazone medicines as an example.

    The restrictions are based on data that suggested an elevated risk of heart attacks in patients treated with rosiglitazone. The decision to restrict access to rosiglitazone medicines was made on September 23, 2010. The REMS limits the use of rosiglitazone medicines to:

    Patients already being successfully treated with these medicines.
    Patients whose blood sugar cannot be controlled with other anti-diabetic medicines and who, after consulting with their healthcare provider, do not wish to use pioglitazone-containing medicines.

    So the FDA can put a trial on hold, they can define such factors as they see fit to protect patients. They can also terminate drug candidates and stop small pharma's stone cold in their tracks.

    Sentiment: Strong Buy

  • Reply to

    My hopes for the April 12th presentation

    by sdrawkcabeman Mar 29, 2014 4:50 AM
    scistats scistats Mar 29, 2014 1:29 PM Flag

    Imetelstat is not for everyone. I think the FDA is going to impose strict selection criteria on the phase 2 that biases against those with preexisting liver conditions, those with other preexisting medical conditions that make them particularly susceptible to myelosuppression, and those that either respond unfavorably due to other side effects or lack an initial favorable response, clinically or otherwise. Primary end point should then be CR's and PR's over a duration.

    Dr. Tefferi and Dr. Scarlett commented that Mayo was accepting some very sick people, people who would probably not pass the above criteria.

    Whether there were more or less of these patients and whether including these patients constitutes a true random selection of myelofibrosis patients is unknown, but they implied that there were a lot of very sick people in the trial, so my guess is the Mayo name itself may have selected for the most sick who were among those looking for final options. Because these people are in particularly bad condition, they are likely to skew the results in an unfavorable direction and reduce CR's and PR's, and in addition, contribute to all kinds of questionable side effects that may or may not affect a patient with earlier stage disease in better health.

    Sentiment: Strong Buy

  • Reply to

    My hopes for the April 12th presentation

    by sdrawkcabeman Mar 29, 2014 4:50 AM
    scistats scistats Mar 29, 2014 6:50 AM Flag

    Yes, Dr. Tefferi mentioned in his video "Drug Induces Morphologic, Molecular and Clinical Remissions" that they need larger numbers to prove the frequency of CR's and PR's. The way forward is a phase 2 which is why he wants to proceed ASAP. He proved CR's and PR's are possible at a rate of 20% without selection bias for conditions of any kind. Progress will require a phase 2. Further enrollment without bias will only rack up withdrawals and patients in impossible conditions that will create liver and other issues due to near death conditions.

    Sentiment: Strong Buy

  • Reply to

    Geron legal counsel is silicon valley stalwart

    by scistats Mar 27, 2014 6:02 AM
    scistats scistats Mar 28, 2014 4:53 AM Flag

    Exactly!...I think?

    Sentiment: Strong Buy

  • Reply to

    Geron legal counsel is silicon valley stalwart

    by scistats Mar 27, 2014 6:02 AM
    scistats scistats Mar 28, 2014 12:25 AM Flag

    Search the FDA Orphan Drug Designations and Approvals.
    There are already multiple drugs that have orphan designation for myelofibrosis.
    Until there is a cure for the majority of patients, this will be the case.

    Sentiment: Strong Buy

  • Reply to

    Geron legal counsel is silicon valley stalwart

    by scistats Mar 27, 2014 6:02 AM
    scistats scistats Mar 27, 2014 7:16 PM Flag

    If you listen to the last conference call, Dr. Scarlett, during the Q & A, mentions that the FDA has not previously focused on low level persistent liver enzyme abnormalities during treatment. So this is somewhat of a first.

    In addition, and this is a big part of this. When a panel of experts clears the liver data as well as the Mayo Clinic, I think low level liver function changes are sufficiently vetted to be medically and ethically ok to continue forward, especially since the acute liver enzyme abnormalities was proven entirely reversible. So, Geron was indeed keeping a close watch on liver function, and their counsel had to base their decision on the panel of liver experts.

    Why? Well, perhaps, Geron counsel could have cross checked this enzyme issue with the FDA, but you have to remember that, if you approach a regulatory agency, they are then obligated, by protocol, to find a rule that matches the problem or else put everything on hold until they develop a case specific rule. It is kind of like calling 911. If you pick up a phone and dial those numbers, you better have an emergency because you are setting off a chain of events. So, Geron has to be measured in what they run to the FDA with because it equates to nothing less than a formal, documented emergency call.

    Once in motion, the FDA response involves a huge, slow moving bureaucracy, and the end result is a big question mark of anyone person best guess. Anything could happen.

    Indeed, Geron needs to know all of the liver function results before a phase 2 should begin, but if the FDA jumps in too soon, they will ruin clarification of any outcome because you simply cannot gather data if the FDA halts a trial every time liver enzymes fluctuate in a low level way. As diagnostics improve, even more fluctuations can be spotted which may have no relevant meaning in the long term big picture, so perspective is needed and more than anything, common sense reasoning. People are dying for goodness sake.

    Sentiment: Strong Buy

  • Cooley represents thousands of clients in a wide range of industries from offices in eleven major commercial markets. We are counselors, strategists and advocates for the foremost private and public companies. We have a legacy of representing companies bringing to market breakthrough products and technologies and frequently argue cases that fall in new areas of law, brought about by technological developments. Our business and litigation practice reaches across a broad array of dynamic industry sectors, including technology, life sciences, clean tech, real estate, financial services, retail and energy. With 750 attorneys throughout the U.S. and in China, Cooley has the range and expertise to serve companies of all sizes to seize opportunities in today's global marketplace.

    Sentiment: Strong Buy

  • Recruiting: Imetelstat Sodium in Treating Younger Patients With Recurrent or Refractory Brain Tumors

    Sentiment: Strong Buy

  • Slick!

    Sentiment: Strong Buy

  • Its the FDA chasers!

    Sentiment: Strong Buy

  • And they do it from the bottom of their hearts with only the poor victims benefit in mind.
    All you have to do is sign the dotted line, and they will give you what you deserve.
    Selflessly working just for you.

    Sentiment: Strong Buy

GERN
1.94-0.03(-1.52%)Apr 17 4:00 PMEDT

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