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Geron Corporation (GERN) Message Board

sidesaddlex 60 posts  |  Last Activity: 4 hours ago Member since: Oct 5, 2005
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  • sidesaddlex sidesaddlex 4 hours ago Flag

    Jack--This is an excellent post. "This is one of the reasons that I keep stressing the importance of combo drugs." This should get much attention. "There is a way around telomerase, in which cells can code for telomere maintenance without the enzyme." I think you are saying that all cancer cells contain telomeres, but Imetelstat (telomerase) is not the only way to control their length. Telomere length seems to be closely related to the survival of cancer cells.

  • sidesaddlex sidesaddlex Mar 25, 2015 10:36 AM Flag

    The "market games" are still going on to my surprise. The Janssen/JNJ inputs and partnership makes this a $10 stock in the near future, as I see it. I am willing to wait, since I believe in the science here.

  • Reply to

    FDA Advanced Approval Seems in the Cards

    by lws2000 Mar 18, 2015 4:30 PM
    sidesaddlex sidesaddlex Mar 20, 2015 9:44 AM Flag

    I have a gut feeling that the FDA has made up their mind, and the result is positive for patients and Imetelstat. When will they speak?

  • sidesaddlex sidesaddlex Mar 15, 2015 10:48 AM Flag

    Certain: (Synonyms) assured, clear, cocksure, confident, doubtless, implicit, positive, sanguine

    The exact meaning of "certain" is not "certain", and depends on usage. Nothing is a sure thing, but a very high degree of "confidence", based upon medical evidence, can be "Tantamount to a Cure" . Your use of the word "lying" is a sign of a very narrow understanding of the English language.

  • sidesaddlex sidesaddlex Mar 10, 2015 9:11 AM Flag

    The data from Imetelstat (IMET) blood cancer studies (MF/MDS/AML) all appears to show that IMET is safe and brings remissions in humans. That alone should get the FDA's attention and advanced-approval. JNJ/Janssen and Dr. Tefferi are moving IMET forward as rapidly as they can. In my opinion, that makes for a very sound investment, with significant potential.

  • sidesaddlex sidesaddlex Mar 7, 2015 2:42 PM Flag

    I think that JNJ spotted IMET early-on, when Dr. T first got involved with the MF trials. The talk of remissions only increased their interest. Geron was allowed to survive as a public company (matter for discussion), but JNJ now has control of IMET's future, which could take several paths. There will be no bidding wars, because JNJ has complete control, and has decided that corporate secrecy serves their best interests.

  • sidesaddlex sidesaddlex Mar 6, 2015 1:42 PM Flag

    Dr. Tefferi moves to Janssen (Conference Call, March 3)
    *********************
    Janssen responsible for operational implementation of these activities.

    Development of imetelstat will proceed under a mutually agreed clinical development plan, which is expected to include Phase 2 studies in MF and myelodysplastic syndromes ("MDS") as initial studies, additional registration studies in MF and MDS, and exploratory Phase 2 and potential follow-on Phase 3 studies in acute myelogenous leukemia ("AML"). The company expects the Initial Phase 2 MF Study to be initiated in mid-2015 followed later by the Initial Phase 2 MDS Study to be initiated at the end of 2015. Development costs for these two studies will be shared between Janssen and Geron on a 50/50 basis.

    Prior to initiation of the Initial Phase 2 MF Study, both investigational new drug applications for imetelstat and the sponsorship of the MF Pilot Study being conducted by Dr. Tefferi will be transferred from Geron to Janssen. The primary transition activities related to the imetelstat program are expected to be completed by mid-2015.

  • sidesaddlex sidesaddlex Mar 3, 2015 10:53 AM Flag

    If one only looks at the charts and the technicals for Geron, one gets the message "hoax". The medical successes give a completely different message (IMET, remarkable drug).

  • sidesaddlex sidesaddlex Mar 2, 2015 5:39 PM Flag

    There is some valuable information on this board, but, of course, it all needs to be verified. All information indicates to me that IMET is real, safe, and remarkable (no hoax). The PPS has to follow the good-news that is already known.

  • sidesaddlex sidesaddlex Feb 25, 2015 12:18 PM Flag

    DNDN did collapse. At the time of its rise, it appeared that DNDN had an unique treatment for prostate cancer causing the rapid move upward in the PPS. The collapse came, apparently, when it was shown that their drug was not the best treatment available. I think IMET is too universal in application (alone and in combination) for a collapses similar to DNDN after a sharp rise. Telomere lengths seem to be fundamental to all cancer cells.

  • sidesaddlex sidesaddlex Feb 24, 2015 10:21 AM Flag

    Summary of the AML project in Australia (Proof-of-Concept at ASH): Preclinical data demonstrating activity of the company`s telomerase inhibitor drug, imetelstat, on leukemic stem cells from acute myelogenous leukemia (AML).

    The preclinical study showed the role of telomerase in AML disease initiation and progression. These data provide preclinical proof-of-concept to support clinical development of imetelstat in AML.

    The study was co-authored by Dr. Steven Lane and colleagues at QIMR Berghofer Medical Research Institute in Australia in collaboration with Geron scientists and published online on December 4, 2014 in the journal Cell Stem Cell. In addition, companion preclinical research on imetelstat in animal models of AML was selected for presentation as a poster at the upcoming 56th American Society of Hematology Annual Meeting (Abstract #2322, Inhibition of Telomerase with Imetelstat is Detrimental to Leukemia Stem Cells in Acute Myeloid Leukemia).

    Leukemic stem cells (LSCs) are functionally described as cells within AML that are capable of initiating and maintaining the disease. Through their high expression of telomerase, LSCs are believed to be responsible for chemotherapy resistance and relapse in AML which make them an important therapeutic target as a durable treatment for AML.

    In the study, mice were transplanted with AML grafts from normal and telomerase deficient donor mice. Mice that received telomerase deficient grafts were shown to have reduced LSC functions and experienced cell cycle arrest and programmed cell death. This resulted in prolonged survival of telomerase deficient AML mice as compared to normal AML mice, providing proof-of-principle of the role of telomerase in maintaining LSCs.

  • Reply to

    Agree?

    by blackmarango Feb 22, 2015 3:59 PM
    sidesaddlex sidesaddlex Feb 22, 2015 8:40 PM Flag

    Black***---It seems that we agree that IMET is an outstanding drug, that deserves some special attention from the FDA now, based upon the lifesaving work done (remissions) at Mayo Clinic (MF, humans). We also agree, I believe, that Geron had some shortcomings, that could only be redeemed by a major partner in oncology (JNJ/Janssen). The FDA and the JNJ-Mayo-Geron team should be able to get it right, with blood cancer patients being the major beneficiaries, and also benefitting long term investors. Assuming the FDA, has been properly asked to the party, the FDA should respond to the invitation with a resounding "YES". As far as I can tell, IMET has meet all criteria for advanced-approval.

  • Of course, if no "advanced approval" is granted by the FDA for Imetelstat (IMET), then it will be a very long time before it is available as a useful drug in treating cancer globally: (MF, MDS, AML {blood cancers} first, and other cancers latter). The normal phase 2 & 3 procedures do not allow shortcuts, and can take a very long time, with no guarantee of success. An accelerated or advanced approval is justified only if a medicine has met certain criteria. IMET seems to have met all of those.

    If JNJ/Janssen-Geron filed for advanced approval, it was done in totally secrecy, as I believe is required. Some people, IMO, are confusing 2 different procedures: (1) Advanced approval (fast track, breakthrough, etc.), (2) Standard approval (phase 2 & phase 3 long testing periods). Advanced approval can happen at anytime (assuming a proper request is made), and is for a life saving medicine, that is unique and safe. IMET meets all of those criteria. The FDA has every reason to grant some sort of advanced approval, IMO.

    Geron may have been weak in dealing with the FDA (faulty data collection, little credibility, safety issues, dubious data, administrative problems, etc.), but by choosing very strong advocates and partners (JNJ & Mayo), all of the short-comings have been corrected. JNJ and Mayo want advanced approval for IMET, and know the proper procedures. They will steer Geron in the right direction, and that will aid the PPS.

  • sidesaddlex sidesaddlex Feb 21, 2015 3:18 PM Flag

    stoke & black: Are you saying that if JNJ/Janssen-Geron files for advanced approval (done in totally secrecy), and it is granted no one is told? That makes no sense because you are confusing 2 different procedures: (1) Advanced approval (fast track, breakthrough, etc.), (2) Standard approval (phase 2 & phase 3 long testing periods). Advanced approval can happen at anytime (assuming a proper request) and is for a life saving medicine, that is unique and safe. IMET meets all of those criteria.

  • sidesaddlex sidesaddlex Feb 21, 2015 10:09 AM Flag

    The safety factor for IMET is now positive (reversed from the period of the liver-holds). Compassion and patient's needs guarantee (in a rational world) FDA advanced approval, soon (cannot define soon).

  • sidesaddlex sidesaddlex Feb 20, 2015 2:23 PM Flag

    Imetelstat has had tons of publicity (ASH, Stifel, Piper Jaffray, Mayo Clinic brochure, etc.), but the PPS is still near $3.00. That makes no sense. JNJ and the FDA "has gone dark", which means the "light and hope of cancer remissions, and FDA advanced approval" is near (days, weeks, months?). IMET has no significant negatives.

  • sidesaddlex sidesaddlex Feb 18, 2015 3:09 PM Flag

    Commonsense: JNJ has had recent experiences with the FDA with several drugs that were granted priority reviews. In all likelihood that will happen with IMET. IMET is ready for the big leagues, and JNJ has every reason to encourage maximum use of IMET. JNJ knows the procedures. Geron, I believe, got bogged down in all sorts of administrative problems, and needed JNJ to bail them out.

  • sidesaddlex sidesaddlex Feb 18, 2015 12:15 PM Flag

    The PPS depends on FDA Fast Track, which seems to be in the works, and the ability of short-hedge-funds to stay in control. I think the hedge funds are losing ground, as IMET successes and potential gets better known and believed by investors.

  • sidesaddlex sidesaddlex Feb 17, 2015 10:15 AM Flag

    I will say it again. Imetelstat is already a success. Mayo Clinic has said it, "Tantamount to a Cure". JNJ has said it with their check book. The FDA is slow, and almost remiss.

  • sidesaddlex sidesaddlex Feb 17, 2015 8:30 AM Flag

    JNJ is in a position to see the big-picture, and has the financial power, global presence, FDA access, and oncology expertise to bring IMET along as fast as they wish, alone or in combination with other drugs. I think they are still evaluating what they have, and for that reason they are not saying much, at the moment. Dr. Scarlett and Dr. Tefferi are at many health conferences, maximizing the news, but that hasn't caught-on with most investors, for market-reasons, not medical-reasons.

    The primary reason for moving faster seems to be the welfare of the patients that are currently denied IMET, which could save their lives. The reason for moving slower, is to make sure that all safety features are adequately evaluated. That is the dilemma.

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