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Allergan plc Message Board

comsensea 98 posts  |  Last Activity: 13 hours ago Member since: Dec 28, 2001
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  • comsensea comsensea 13 hours ago Flag

    Is there any medical or scientific reason for IMET to not be fully approved by the FDA and EMA.? No one on this board has found one. JNJ, being very conservative, must want an abundance of statistically proof about IMET that goes deeply into genetics, and why some patients benefit more than others (improvements, remissions, cures, etc.). With 24 week trials (enrollments starting June 2015, infusions starting September, 2015) they (JNJ, FDA, EMA) must be close to conclusions that they can share.

    IMET works, so it must be approved. JNJ has called IMET a "transformative" medicine, and still does.
    The FDA is very sensitive to patients' unmet needs, especially when there are life and death matters involved, such as blood cancers (MF, MDS, AML, others).

    No one has found a medical reason to deny new advanced approvals, so they are going to happen. The question is when. That is up to JNJ and the FDA (or another one of the 12 ASCO countries). The next approval will come soon and without warning, IMO.

  • comsensea comsensea Jun 25, 2016 9:56 AM Flag

    Several important oncology conferences on the road to ASH-2016 that follow-up ASCO-2016. Here is one (don't know who is presenting, or if Imetelstat is on the agenda):

    ICAHO 2016 — 4th International Conference on Advances in Hematology and Oncology

    13 Aug 2016 - 14 Aug 2016

    Location

    Coeur d’Alene, United States

    The goal of 4th International Conference on Advances in Hematology and Oncology (ICAHO 2016) is to improve the care of hematology and oncology patients by updating the hematology and oncology care providers about the new developments in the field. This ICAHO 2016 conference also provides attendees with opportunities to interact and network with top experts in hematology and oncology.

  • Reply to

    Trump congratulates Scotland on leaving EU.

    by wgboxmanl403 Jun 24, 2016 8:45 AM
    comsensea comsensea Jun 24, 2016 2:05 PM Flag

    Some people believe that the USA presidential election is about the lesser of two evils. Others believe that Trump is not electable under any circumstances. Trump's "knack for foreign policy" is amazing.

  • comsensea comsensea Jun 23, 2016 8:46 PM Flag

    Listen to Dr. Tefferi and any news from Janssen/JNJ concerning Imetelstat. They are the only important factors concerning IMET approvals, with the data from and the results of the continuing trials. The FDA and the EMA must support IMET (beyond ODD status) to move the Geron PPS higher. ASCO-2016 is compelling, but support from the FDA and EMA are necessary to move the PPS to the Piper Jaffray prediction ($10).

  • comsensea comsensea Jun 23, 2016 11:13 AM Flag

    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."

    This review was presented by Dr. Tefferi and others (worldwide reputations) as a follow-up to Dr. Tefferi's article in the NEJM. It shows: 1. complete and partial remissions, 2. molecular remissions. It also indicates likely clinical benefit to the sickest of MF patients, that had been on JAK, but no longer can benefit from that medicine.

    Dr. Tefferi (Janssen /JNJ & Mayo Clinic) knows everything about Imetelstat that can be known. The "key" is "unmet needs" that only IMET can provide. JNJ is proceeding with IMET trials internationally, as the positive indications increase.

  • comsensea comsensea Jun 20, 2016 8:13 AM Flag

    Everything considered and publically revealed by JNJ (Janssen) indicate that JNJ is pursuing the IMET trials in number (~100 and expanding) and scope (MF, MDS, AML next). JNJ is "dotting all i's and crossing all t's". The EMA and the FDA are closely involved (ODD status from both). IMET fills "umet blood cancer needs" (ASCO 2016). New approvals are in the oven.

  • comsensea comsensea Jun 19, 2016 1:58 PM Flag

    The top issues for discussion on this board are:

    1. How can IMET be medical so good and not have full approvals?
    2. Why is the PPS so low?
    3. How can blood cancers "unmet medical needs" be ignored by JNJ, the FDA and the EMA?

    The answer, I believe, is that JNJ is being ultra-conservative in sharing their trial data, and the investment public will not believe in IMET as a cancer "breakthrough" until the FDA or the EMA approve IMET beyond ODD. This has to change soon, since blood cancer patients are dying worldwide from their diseases.

  • Reply to

    JNJ Rarely Makes a Mistake; "IMET Story"

    by sidesaddlex Jun 15, 2016 8:31 PM
    comsensea comsensea Jun 16, 2016 10:14 AM Flag

    Meant "kitchen sink" not "sick", which could be a play on words.

  • Reply to

    JNJ Rarely Makes a Mistake; "IMET Story"

    by sidesaddlex Jun 15, 2016 8:31 PM
    comsensea comsensea Jun 16, 2016 9:53 AM Flag

    Most investors consider an unapproved cancer medicine, with that being the companies only medicine, very speculative. Most investors will not believe the "IMET story" until there are advanced approvals from the FDA, the EMA, or another ASCO listed countries (12). ODD is a form of low level approval (from FDA & EMA) and a first important step, but not enough for most investors.

    "The stock market is forward looking". I agree with that. I believe that JNJ's follow up and expansion (100 or so worldwide trials) of Mayo Clinic's successful pilot studies have already proved to be conclusive. Most others are apparently going to wait for new approvals (FDA, EMA, other), putting manipulators in control of the PPS. $2.69 is ridiculously low if I am correct. JNJ is in control of IMET in all ways, and they appear to be putting "the kitchen sick" into IMET's progress.

  • Reply to

    JNJ Rarely Makes a Mistake; "IMET Story"

    by sidesaddlex Jun 15, 2016 8:31 PM
    comsensea comsensea Jun 16, 2016 7:02 AM Flag

    Compare the positive news about IMET with the negative news. I challenge anyone to extend the negative list. The "unmet medical needs" for blood cancers now, and all cancers later are all on IMET's side. The FDA and the EMA both know this. JNJ is rapidly building the statistics and the case studies (genetics, mutations, etc.). They are taking the sound, scientific approach, which is very hard on current patients not in the trials.

    1. Positive: remissions, disease modifying, safe, saves lives, unique, needed now, combination enhanced.
    2. Negative: None

  • comsensea comsensea Jun 15, 2016 9:08 PM Flag

    I separate Geron's PPS from IMET's medical and scientific successes. My premise is that advanced approvals (FDA or other) will move Geron's PPS higher. I will have to wait and see if I am right. "Umet Medical Needs" and a good safety profile mean new approvals (beyond ODD) are nearly a certainty. Who will be first: North America (2 countries), Europe (7 countries), Asia (3 countries)? My guess is someplace in Europe or the entire EU (EMA), before the USA (FDA).

  • comsensea comsensea Jun 15, 2016 8:38 AM Flag

    IMET works, so it must be approved. JNJ has called IMET a "transformative" medicine, and still does.
    The FDA is very sensitive to patients' unmet needs, especially when there are life and death matters involved, such as blood cancers (MF, MDS, AML, others).

    No one has found a medical reason to deny new advanced approvals, so they are going to happen. The question is when. That is up to JNJ and the FDA (or another one of the 12 ASCO countries). The next approval will come soon and without warning, IMO.

  • comsensea comsensea Jun 14, 2016 8:31 PM Flag

    The evidence is the pilot trials at Mayo Clinic and the continuing trials by JNJ in all parts of the world. Geron's PPS has been a disappointment, but Imetelstat in JNJ-Janssen's hands has been a screaming success. JNJ is in control of the trials and the released information (content, place, time). JNJ has the luxury of getting it all right and detailed so the FDA and others are sure of the results (statistically, medically, scientifically).

  • comsensea comsensea Jun 11, 2016 11:12 AM Flag

    I doubt that this will happen. Chippy feels responsible for Geron's successes, since he brought Mayo Clinic (Dr. Tefferi) and JNJ-Janssen on board as the dominant medical partner with the "big bucks". He also knows that IMET has already succeeded and the longer he stays involved the richer he gets. Geron still owns IMET (JNJ controls the future), and Chippy is president of Geron. How do you plan to remove him?

  • Reply to

    ASCO 2016 Imetelstat Posters Found

    by lws2000 Jun 7, 2016 6:48 PM
    comsensea comsensea Jun 7, 2016 10:45 PM Flag

    JNJ is an outstanding company technically, financially, and with good business practices. They would not be in all of these countries unless these strengths were proven beyond a doubt. Imetelstat is all of these things: safe, unique, remissions, disease modification, unmet medical needs, saves lives.
    ****************************************************************************************
    STATUS (from poster)

    • Approximately 97 sites are planned in 12 countries (Figure 3).

    • Enrollment began in June 2015 and is ongoing.

    • As of May 25, 2016, there are 77 active sites.

    • Belgium
    • Canada
    • France
    • Germany
    • Israel
    • Italy
    • South Korea
    • Spain
    • Switzerland
    • Taiwan
    • United Kingdom
    • United States

    . .

  • comsensea comsensea Jun 7, 2016 4:56 PM Flag

    Thanks Bigkosh. We now know that the Tefferi-Mayo Clinic-Janssen poster exists (imetelstat.eu). We will see if there is any follow-up.
    **********************
    STATUS (from poster)

    • Approximately 97 sites are planned in 12 countries (Figure 3).

    • Enrollment began in June 2015 and is ongoing.

    • As of May 25, 2016, there are 77 active sites.

    • Belgium
    • Canada
    • France
    • Germany
    • Israel
    • Italy
    • South Korea
    • Spain
    • Switzerland
    • Taiwan
    • United Kingdom
    • United States

  • comsensea comsensea Jun 7, 2016 4:30 PM Flag

    About 30,000 people attended ASCO 2016. Many saw the Tefferi-Mayo-Janssen exhibit, and many have pictures. It is not a secret. Why is it so hard to find?

  • comsensea comsensea Jun 7, 2016 3:20 PM Flag

    http://cmesyllabus.com/wp-content/uploads/2016/03/04-Tefferi.pdf

    Great read for non bashers--(from demboys--)
    ********************************************************************************
    cheng_ho--Take a look at this post and tell me what you think. Is this what we are looking for, or is it from another place? It is a poster presentation.

  • comsensea comsensea Jun 7, 2016 11:16 AM Flag

    Cannot find "Investor News Updates". It is not under Geron news on the Web Site. This is not a Geron presentation (JNJ-Janssen & Mayo Clinic where Dr.T is a principle IMET investigator). I think you have a credibility problem.

  • comsensea comsensea Jun 7, 2016 10:28 AM Flag

    Look at ASCO University meeting library. Put in the meeting (ASCO 2016 annual meeting), the speaker (Dr. Tefferi), the abstract (TPS7079), and the keyword (Imetelstat). This is the right place. The message back is "Poster Presentation not Available Yet"

AGN
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