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lws2000 249 posts  |  Last Activity: 10 hours ago Member since: Nov 21, 2001
  • Reply to

    (ODD) shows FDA Support for IMET

    by lws2000 Jun 19, 2015 8:02 AM
    lws2000 lws2000 Jun 19, 2015 6:55 PM Flag

    JNJ/Janssen will push IMET to the maximum. We are just beginning to understand the science of and the role of telomeres:

    1. MF (blood cancer--1st successes)
    2. MDS, AML (other blood cancers)
    3. cancer stem cells
    4. solid cancers
    5. aging cells
    6. immortal cells

    The fundamentals of life are locked away here. This will be a major focus of medical science for the rest of the 21st century and beyond. More immediately the 36+ JNJ/Janssen (24 week) trials will provide new information about the potential and safety of IMET. Geron found IMET, brought it to Mayo Clinic, and partnered with JNJ/Janssen. JNJ/Janssen is about to discover "hidden-details" about IMET (good, great, or miracle). We, as long term investors, will find out how that effects the PPS. The world is watching and waiting.

  • Reply to

    (ODD) shows FDA Support for IMET

    by lws2000 Jun 19, 2015 8:02 AM
    lws2000 lws2000 Jun 19, 2015 1:43 PM Flag

    The FDA realizes that the work with IMET is just beginning (with the IMET successes at Mayo Clinic) and there is much work to be done with other cancers and combination medicines. Orphan drug status provides a financial incentive to develop this drug, but immediate use for needy MF patients is another.

  • Reply to

    (ODD) shows FDA Support for IMET

    by lws2000 Jun 19, 2015 8:02 AM
    lws2000 lws2000 Jun 19, 2015 11:42 AM Flag

    You are correct about the "long and short" channel traders. These are not long term investors, who are a different breed entirely.

  • Reply to

    (ODD) shows FDA Support for IMET

    by lws2000 Jun 19, 2015 8:02 AM
    lws2000 lws2000 Jun 19, 2015 10:25 AM Flag

    With so much good news, and no counterbalancing bad news, it seems that Geron's PPS would have already spiked much higher. As some have pointed out, the PPS is still in a narrow channel around $4.

    It is not clear to me who or what is holding the PPS in check, or how they are doing it. Some think that short hedge funds are in control, others think that JNJ has reasons to keep the PPS low, others talk about computer programs that define and play "channels", still others talk about illegal manipulation of the stock. The FDA is showing support for IMET with the ODD (orphan drug designation), and that should be good for the Geron PPS. The science (Nobel Prize) and medical successes are real. That will not change.

  • The FDA looked at the data that Dr. Tefferi had collected at Mayo Clinic and then transferred to JNJ/Janssen. They found the data to be good, and the MF patient's needs to be compelling (ODD). The data collection is continuing (36 or so international trials).

  • lws2000 lws2000 Jun 18, 2015 4:28 PM Flag

    We closed above $4.00 (barely). The closing prices and the channels are too tidy for there not to be some manipulation. The FDA, after closing GERN & IMET down with the liver holds ( probably by INCY influence--now lifted), now has reversed course with ODD. This indicates that JNJ has more (good scientist, good research, FDA's ear) going for it than INCY. I believe that IMET will benefit from ODD and the FDA's support, but it has been a long road. I hope to see the stock price significantly higher, very soon.

  • lws2000 lws2000 Jun 18, 2015 3:17 PM Flag

    black: The mystery continues. The stem cell projects never really worked, although they still show long term promise. IMET clearly works (Mayo Clinic) and JNJ is putting major resources into them (money, time, talent, global trials). I think a JNJ buyout is coming , but I have no idea where or when that will be. I also do not know what "rights" JNJ has to hold off any competition.

  • With so much good news, and no counterbalancing bad news, it seems that Geron's PPS would have already spiked much higher. It is not clear to me who or what is holding the PPS in check, or how they are doing it. Some think that short hedge funds are in control, others think that JNJ has reasons to keep the PPS low, others talk about computer programs that define and play "channels", still others talk about illegal manipulation of the stock. The FDA is now on IMET's side with ODD (orphan drug designation), and that is good for the Geron PPS. The science (Nobel Prize) and medical successes are real.

  • Reply to

    ODD & the FDA are now in Charge (IMET)

    by sidesaddlex Jun 18, 2015 11:21 AM
    lws2000 lws2000 Jun 18, 2015 12:53 PM Flag

    Irish--The main criteria for a designated (life-saving) orphan drug is that it is safe, effective (remissions), and unique. That is the perfect description of IMET. I believe the FDA wants more data, from trials that they helped to design, before they grant full approval. That is what JNJ is doing internationally.

  • Reply to

    ODD & the FDA are now in Charge (IMET)

    by sidesaddlex Jun 18, 2015 11:21 AM
    lws2000 lws2000 Jun 18, 2015 12:18 PM Flag

    kpail--This information is from the FDA site. You can read this anyway that you wish, but it seems to me that the OOPD is tasked to provide incentives, collaborate, promote, and make designated orphan drugs available to needy patients in any way that is practical.

    "The FDA Office of Orphan Products Development (OOPD) mission is to advance the evaluation and development of products (drugs, biologics, devices, or medical foods) that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions. In fulfilling that task, OOPD evaluates scientific and clinical data submissions from sponsors to identify and designate products as promising for rare diseases and to further advance scientific development of such promising medical products. The office also works on rare disease issues with the medical and research communities, professional organizations, academia, governmental agencies, industry, and rare disease patient groups. OOPD provides incentives for sponsors to develop products for rare diseases. The program has successfully enabled the development and marketing of more than 400 drugs and biologic products for rare diseases since 1983. "

  • lws2000 lws2000 Jun 18, 2015 10:20 AM Flag

    Black--JNJ is in charge, and, I believe responsible for this Orphan-Drug-Designation (ODD). As you said many times, the Geron PPS could not move without an effective major pharma partner. ODD is an early, temporary form of accelerated-approval. All I can say (and hope for) is that "Great News" means great prices, final & total approval and that the upward trend is now in place for a very long time, which may be cut short by a JNJ buyout. I don't see a reversal of the "Great News" in these new international trials.

  • lws2000 lws2000 Jun 18, 2015 8:12 AM Flag

    The New-Geron (after JNJ partnership) is led by JNJ/Janssen, and is dedicated to promoting Imetelstat ((IMET) in all its forms worldwide. The new orphan-drug-status is a timely and surprising advance, showing full FDA support. IMET has crossed it highest hurdle now, and the rest should fall into place as the numerous (about 36) 24 week international trials progress. JNJ/Janssen and the FDA are now fully supporting IMET, and are working closely together for final and total approval that will give maximum benefit to all blood cancer victims now, and all cancer victims in the future. The telomere science and the IMET medical successes are finally getting their proper due. Those long term investors, that are properly concerned about the PPS, should see a steady trend upward, as the controlling hedge funds back off.

  • lws2000 lws2000 Jun 17, 2015 11:47 PM Flag

    qualifies (not qualities)--correction

  • lws2000 lws2000 Jun 17, 2015 11:39 PM Flag

    Orphan-drug-status is a limited form of accelerated-approval used when a medicine (Imetestat) shows good results (Mayo Clinic) in a life threatening orphan disease (MF), where there is no other practical treatment (remissions only with IMET). IMET qualities on all counts, but the final chapter is now in the process of being written (36 + international trial sites). The odds for full and complete approval are near 100%, when one considers the previous successes at Mayo Clinic, and the excellent safety profile.

    "7. ODD has higher rates of approval 82% compared to non-orphan at 35%. Of the 36 new drugs launched in 2013, 17 were ODD."

  • lws2000 lws2000 Jun 17, 2015 9:19 PM Flag

    JNJ/Janssen knows what they are doing, and will correct the lagging Geron PPS.

  • lws2000 lws2000 Jun 17, 2015 9:13 PM Flag

    JNJ/Janssen has partnered with Geron, with successful MF trials at Mayo Clinic for starters, to take Imetelstat to new levels on interest worldwide (36 known new trials and counting). The Geron PPS is lagging, as many have pointed out, but that is destined to change. JNJ/Janssen knows what they are doing.

  • 1. ODD now allows use of Imetelstat in primary orphan drug designation (MF) and in any other indication; and is gateway to MF (and other) registry studies.
    2. ODD allows for a Fast Track procedure to evaluate registration files.
    3. ODD reduces waiting period and provides priority FDA review of new drug applications (6 months instead of 10 months).
    4. ODD takes, on average, 30% less time to market (3.9 years vs 5.4 years).
    5. ODD allows smaller studies with no placebo required.
    6. ODD provides FDA technical assistance during the elaboration of application file and in design of protocols including written recommendations in clinical and preclinical studies
    7. ODD has higher rates of approval 82% compared to non-orphan at 35%. Of the 36 new drugs launched in 2013, 17 were ODD.
    8. ODD provides availability to patients before market approval when disease is life-threatening, no equivalent treatment is available, and drug in clinical trials and active phase of marketing approval.
    9. ODD provides 7 year exclusivity (monopoly) after market approval.
    10. ODD provides up to a 50 percent research-and-development tax credit on US trials.
    11. ODD waives drug approval application fees and annual FDA fees.
    12. ODD application required disclosure of risk/benefit data and
    13. ODD allows for development of personalized and predictive cancer treatment that target patient populations with a specific cancer causing mutation.
    14. Almost 1/3 of orphan drugs earn more than 1 billion in annual sales. Category has more than 50 billion annually in world wide sales and rising 20% a year past several years.
    15. ODD has produced "rolling blockbusters" - drugs initially may be approved for one indication in a small population, but later acquire additional uses after longitudinal studies and real world observations (registry studies).

  • lws2000 lws2000 Jun 17, 2015 7:44 PM Flag

    Itsamess--Can you read, and understand what you have read? Look at the paragraphs below starting with, "JNJ/Janssen seems to have IMET on the right track now, with the patient's needs coming first.
    Common-sense tells us that IMET is safe and effective."

  • lws2000 lws2000 Jun 17, 2015 5:34 PM Flag

    JNJ/Janssen seems to have IMET on the right track now, with the patient's needs coming first.

    Common-sense tells us that IMET is safe and effective. Common-sense tells us that it is in the patients'
    interest, the FDA's interest, JNJ's interest, Geron's interest, and long investors' interest to use IMET now.
    The FDA realizes that the work with IMET is just beginning with the IMET successes at Mayo Clinic and there is much work to be done with other cancers and combination medicines. Orphan drug status offers financial incentive to develop IMET to the fullest, including immediate use for desperate patients.

  • Reply to

    Approval process

    by itsabird_itsaplane_no_itsjackdaw Jun 17, 2015 1:36 AM
    lws2000 lws2000 Jun 17, 2015 3:10 PM Flag

    The FDA says that each orphan-drug medicine is an individual case, and to be judged on its own merits. Imetelstat is an outstanding medicine in all ways. Tipifarnib (is this real?) obviously failed the test. As you say, common-sense tells us that IMET is a winner with the full support of the FDA (technical and financial). Your motives are unclear, but they do not support cancer patients or the FDA.

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