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lws2000 278 posts  |  Last Activity: 2 hours 57 minutes ago Member since: Nov 21, 2001
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  • lws2000 lws2000 2 hours 57 minutes ago Flag

    Review of ODD (Orphan Drug Designation) granted to Janssen for Imetelstat by both the FDA and EMA.

    "The Orphan Drug Act (ODA) provides for granting special status to a drug or biological product (“drug”) to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation (or sometimes “orphan status”). For a drug to qualify for orphan designation both the drug and the disease or condition must meet certain criteria specified in the ODA and FDA’s implementing regulations at 21 CFR Part 316. Orphan designation qualifies the sponsor of the drug for various development incentives of the ODA, including tax credits for qualified clinical testing. A marketing application for a prescription drug product that has received orphan designation is not subject to a prescription drug user fee unless the application includes an indication for other than the rare disease or condition for which the drug was designated."

    This is one level of approval. It is now time for new, advanced and full approvals since Imetelstat fills "unmet medical needs" in a safe and unique manner. Imetelstat should be available to all blood cancer patients, alone on in combination as a life saving medicine.

  • New Approvals are coming very soon (unmet needs, life saving, safe, effective).

  • Dr. Tefferi and his group of world class oncology experts told us at ASCO-2016, that approvals are coming for "unmet needs". Since Imetelstat has met all of the necessary criteria, there is an excellent chance that July 2016 will be the month. Who will be first, the FDA or the EMA? JNJ has accumulated and analyzed a great amount of data since June 2015, and the process is continuing.

    ***Excerpt from ASCO-2016-----"Ruxolitinib, a JAK1/JAK2 inhibitor, is the only approved therapy for MF, and there are no approved treatment options for pts who fail ruxolitinib. There is a great unmet need for effective therapy for this pt population. A pilot study of imetelstat therapy in MF demonstrated complete and partial remissions, including some molecular remissions (Tefferi et al, N Engl J Med2015). Based on the novel mechanism of action imetelstat may provide clinical benefit to pts with intermediate-2 or high-risk MF with refractory/relapsed disease after JAK inhibitor therapy."***

  • lws2000 lws2000 Jun 28, 2016 10:32 AM Flag

    ASCO stands as the definitive information for Imetelstat.

  • lws2000 lws2000 Jun 27, 2016 1:05 PM Flag

    No safety issues, continuing trials, medical successes, no bad news, unmet needs. Why not fully approve (FDA, EMS Asia)?

  • 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).

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