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Allergan plc Message Board

lws2000 110 posts  |  Last Activity: Jul 14, 2016 2:27 PM Member since: Nov 21, 2001
  • lws2000 lws2000 Jun 24, 2016 11:29 AM Flag

    ASCO-2016 is the entry point to ASH-2016. There are several major health conferences along the way that will tell us more about IMET in continuing and expanding JNJ trials. The FDA and EMA advanced approvals could come at anytime. JNJ/Janssen's "medical-actions" concerning IMET are only good.

  • lws2000 lws2000 Jun 22, 2016 4:23 PM Flag

    Patient's UMET NEEDS come first (ASCO-2016, Janssen's Imetelstat presentation)

    1. IMET is a transformative cancer drug (proven)
    2. IMET needs FDA and EMA approvals, and will get them
    3. Geron is a one drug company
    4. Both IMET and Geron are totally dependent on JNJ
    5. JNJ is in control

  • Reply to

    imetelstat DOT info

    by fishermangents Jun 22, 2016 12:00 PM
    lws2000 lws2000 Jun 22, 2016 2:30 PM Flag

    I think you are making too much of "Chippy". He found JNJ (as controlling partner), which was his job. Chippy, like the rest of us, is waiting to see if JNJ can "pull it off". with the FDA and EMA. Of course, if JNJ does, Chiippy will be very, very wealthy. Then the argument becomes: Does he deserve it?.

  • Reply to

    imetelstat DOT info

    by fishermangents Jun 22, 2016 12:00 PM
    lws2000 lws2000 Jun 22, 2016 2:12 PM Flag

    Define "wrong":

    1. IMET is a transformative cancer drug (proven)
    2. IMET needs FDA and EMA approvals
    3. Geron is a one drug company
    4. Both IMET and Geron are totally dependent on JNJ
    5. JNJ is in control

  • Reply to

    imetelstat DOT info

    by fishermangents Jun 22, 2016 12:00 PM
    lws2000 lws2000 Jun 22, 2016 1:59 PM Flag

    It is easy to explain. The investing world will not fully believe what JNJ says, that Imetelstat is a "transformative" cancer medicine until there are advanced approvals (beyond ODD, already granted) by the FDA and EMA. Geron is a one drug company, and is totally dependent on JNJ to get IMET approved. That has not happened yet.

  • lws2000 lws2000 Jun 22, 2016 1:28 PM Flag

    The EMA and the FDA will act at Janssen's (JNJ) request. When? No one on this board has come up with a reason to prevent advanced approvals for Imetelstat, beyond ODD.

  • lws2000 lws2000 Jun 22, 2016 9:30 AM Flag

    JNJ has their Imetelstat trial data, results and conclusions constantly being updated and modified for genetics, mutations and combination drugs (continuing and expanding trials). Cancer is many different diseases, with telomere length and the enzyme telomerase in common. It is in JNJ"s interest and patient's benefit to share the data first with the FDA and the EMA (and the 12 countries) for advanced approvals (blood cancers), and with the general public to get the good news known by all. This started with the articles in the NEJM and has continued through ASH-2015, AACR-2016 and ASCO-2016. The Geron PPS is a derivative of all of this plus various market influences. JNJ is in control and releasing information, that all appears good.

  • lws2000 lws2000 Jun 21, 2016 5:15 PM Flag

    BlackM--As I remember there were about 30 MF patients in the original Mayo Clinic MF pilot trial. Now there are about 100 sites for MF and MDS with expansion into AML. I have seen total numbers of patients well into the hundreds, but that number, as far as I know, has never been released. JNJ understands what the FDA and EMA require, and good statistics is high on the list. The trials started to enroll in June, 2015 and the first infusions were in September, 2015. ASCO talked about IMET being the only medicine available for "unmet medical needs". JNJ has the evidence and it is statistically significant (based on logic and public information).

  • lws2000 lws2000 Jun 21, 2016 3:00 PM Flag

    JNJ now has sufficient statistical IMET data, that Mayo Clinic lacked with such a small sample in the MF pilot study. That seems to be the only reason that the FDA and the EMA have not gone beyond ODD status. The ODD approvals were granted to Janssen (JNJ). New approvals will also be granted to Janssen (JNJ), based upon their 100 or so worldwide trials in 12 countries. Janssen is the only one applying, since they have all of the data, results and analyze.

  • Reply to

    EU Approval?

    by blackmarango Jun 20, 2016 11:50 AM
    lws2000 lws2000 Jun 21, 2016 11:08 AM Flag

    Geron does not file drug applications. The ODD status for IMET was filed for and granted to Janssen (JNJ).

  • Reply to

    GERN is in a strangle hold!

    by donquixote2035 Jun 21, 2016 9:41 AM
    lws2000 lws2000 Jun 21, 2016 11:02 AM Flag

    The general belief is that IMET as an important blood cancer medicine has failed, since the FDA and the EMA approvals (beyond ODD) is not forthcoming. All available IMET trial information (Mayo Clinic, JNJ) says the opposite.

  • lws2000 lws2000 Jun 21, 2016 9:17 AM Flag

    " Imetelstat is going after the same MF indication, plus ET, MDS, PV and AML"--(from Trail---)

    1.•Primary Myelofibrosis (MF) – Most commonly seen in men and women over the age of 60, MF is a chronic blood cancer in which the bone marrow function is impacted by scarring. Patients often have associated symptoms and an enlarged spleen. MF can occur in patients with no prior history of an MPN (primary MF) or as a progression of PV or ET.
    2.•Essential Thrombocythemia (ET) – ET is a blood malignancy that is typically characterized by an elevation of platelets in the blood. It is most prevalent in women over the age of 50 and common symptoms include blood clotting and bleeding. ET patients have a later risk of progression to MF.
    3.•Polycythemia Vera (PV) – Characterized by an elevation of red blood cells, PV is most commonly diagnosed in men over the age of 60. PV patients often exhibit elevated white blood cell and platelet counts as well as an enlarged spleen.
    4.•Myelodysplastic Syndromes (MDSs);
    5. •Acute myeloid leukemia (AML)
    These are the blood cancers that are most frequently mentioned. As far as I can tell ET started the ball rolling at Geron, with great success and cures, that got Dr. Tefferi interested at Mayo Clinic and resulted in the MF pilot trials (remissions, etc.). This brought JNJ into the picture (MF, MDS, AML, combinations). We are waiting on the FDA and EMA.

  • lws2000 lws2000 Jun 21, 2016 12:28 AM Flag

    Of course I agree with you. There are certainly several risks in a Geron investment, including disappointments directly from Imetelstat, Geron getting into legal trouble, and a better medicine taking the wind out of its sails.

    The investment is based upon JNJ getting good trial results that satisfy the FDA and the EMA. Balance is always appropriate when risk is involved, and there are no certainties. However, so far, so good, as far a I can tell. ASCO 2016 introduced no negatives.

  • lws2000 lws2000 Jun 20, 2016 11:56 PM Flag

    It certainly was Dr. Tefferi's Mayo Clinic IMET data and results that got JNJ's interest and senior partnership. I don't know Dr. T's exact position at Geron, or even if he accepted any gratuity, but he definitely influenced Geron's decision to not go it alone and ultimately helped pick JNJ. This is based upon logic, since I have no inside information.

  • lws2000 lws2000 Jun 20, 2016 7:52 PM Flag

    BlackM---Actually Dr. T was on the staff of Geron at that time (also retained position at Mayo Clinic). You will remember, that Geron messed up the ET data so badly the FDA imposed a "liver-hold" on Geron and Mayo Clinic. Geron needed Dr. T's MF data to get the holds lifted.

    Around that time Geron realized that they were over their heads and needed a big league partner. They chose JNJ (Janssen). Then Dr. T exchanged his Geron hat for a Janssen hat, which he still wears (also still has his position at Mayo Clinic).

  • lws2000 lws2000 Jun 20, 2016 4:20 PM Flag

    Not at all. JNJ's legal team is excellent, and did everything according to the book, as far as I can tell. I am sure that the "legal eagles" are looking for a victim. JNJ is too rich and too smart for these junior lawyers.

  • lws2000 lws2000 Jun 20, 2016 3:38 PM Flag

    BlackM---That's good that there were other interested parties. However, Dr. S (Chippy) and others (including Dr. T) decided to go with Janssen (JNJ), as the best deal available to bring the FDA and the EMA onboard for new IMET approvals, markets and distribution.

    JNJ is putting everything they have (worldwide) into IMET as a treatment for blood cancers, many other cancers, and the "cancer moonshot". That is all that JNJ can do, and we will have to trust their wisdom and timing.

  • lws2000 lws2000 Jun 20, 2016 1:19 PM Flag

    No body on this board thinks that IMET will be denied advanced approvals by the EMA and the FDA. JNJ knows what they are doing.

  • lws2000 lws2000 Jun 20, 2016 12:05 PM Flag

    There certainly are legal agreements between JNJ and Geron, and they are secret. JNJ, with all the financial, legal, and medical expertise, was and is in a very strong position to dictate terms and protect themselves.

    Geron, a company forced out of the hESC business by the religious-political right, had one recourse, an unproven (still needs approvals) and promising cancer medicine (IMET). JNJ saved Geron from ruin. JNJ is in full control of IMET's and Geron's future, which is good for patients and good for investors.

  • lws2000 lws2000 Jun 20, 2016 11:41 AM Flag

    There is no negative news about Imetelstat (even in the rumor mill). With only positive news and "unmet medical needs", it seems to me that the FDA and the EMA approvals are a given. I see no reasons for advanced approvals to be withheld, but no one knows JNJ's plan for platform (blood cancer) approvals.

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