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Geron Corporation Message Board

sidesaddlex 139 posts  |  Last Activity: Jun 21, 2016 11:45 PM Member since: Oct 5, 2005
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  • sidesaddlex sidesaddlex Jun 21, 2016 11:45 PM Flag

    You miss the point. This is a JNJ venture--- hook, line and sinker. JNJ (Janssen) would have dropped Imetelstat by now, if is were mediocre. They are continuing and expanding the trials. Geron is a one drug company, so if they live or die depends completely on JNJ.

    Imetelstat, we all hope is "precious" and an important part of treating and curing cancer, including the "cancer moonshot". The FDA and the EMA will decide.

  • sidesaddlex sidesaddlex Jun 21, 2016 8:49 PM Flag

    The data is already positive. Janssen requested ODD status and received it (USA & EU). That gives them a great deal of flexibility in setting up their trials and interacting (FDA, EMA, Israel, 12 countries) with the approval agencies.

    We know that the data confirms Dr. Tefferi's Mayo Clinic MF trials (Dr. Tefferi @ ASCO-2016, unmet medical needs). JNJ is in control with a close working relationship that includes the FDA and others. I expect new approvals any day now, considering the unmet needs of blood cancer patients. Why make them suffer any longer?

  • sidesaddlex sidesaddlex Jun 19, 2016 1:09 PM Flag

    These people have endorsed Imetelstat. As a group and individually they have outstanding reputations. They have first hand knowledge of the progress of the JNJ/Janssen continuing IMET trials (MF & MDS), and have direct contact with various approval agencies (FDA, EMA, individual countries). JNJ seems to be going for the whole platform of blood cancers worldwide, with a very conservative, statistically perfect approach.

    The investing world is waiting to hear from these approval agencies, but the medical world has already made their decision that IMET is a transformative blood cancer medicine, that the world needs now (Imetelstat fills "unmet medical needs"--ASCO 2016).
    ***********************************
    Citation:
    J Clin Oncol 34, 2016 (suppl; abstr TPS7079); also ASCO, June 6, 2016

    Author(s): Ayalew Tefferi, Naseema Gangat, Dietger Niederwieser, Jan Van Droogenbroeck, Maria R. Baer, Jean-Jacques Kiladjian, Ronald Hoffman, Guido Finazzi, Francisco Cervantes, Jason R. Gotlib, Shireen Sirhan, Jane Apperley, Angélique Langlois, Ying Wan, Laurie Jill Sherman, Souria Dougherty, Faye Feller, Olatoyosi Odenike; Mayo Clinic, Rochester, MN; University of Leipzig, Leipzig, Germany; AZ Sint-Jan AV Brugge, Brugge, Belgium; University of Maryland Greenebaum Cancer Center, Baltimore, MD; Hôpital Saint-Louis & Université Paris Diderot, Paris, France; Tisch Cancer Institute, Mount Sinai School of Medicine, New York, NY; Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy; Hospital Clínic, IDIBAPS, University of Barcelona, Barcelona, Spain; Stanford University School of Medicine/Stanford Cancer Center, Stanford, CA; Jewish General Hospital, Montreal, QC, Canada; Centre for Haematology, Imperial Collegel, London, United Kingdom; Janssen Research & Development, LLC, Raritan, NJ; University of Chicago, Chicago, IL

  • STATUS (ASCO, June 2016)
    • 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.

    The FDA and the EMA now have statistically sufficient data to make decisions, supplied and analyzed by JNJ. These JNJ trials were designed to last 24 weeks. They have already confirmed the Mayo Clinic pilot trial's successes ("unmet medical needs"). Only IMET can fill these unmet needs (safe, effective, remissions, cures).

  • Reply to

    EU IMET approval sounds imminent

    by chad_dimplebutt Jun 18, 2016 10:53 AM
    sidesaddlex sidesaddlex Jun 18, 2016 5:35 PM Flag

    There is no question that IMET works. ASCO focused on IMET, and patients' needs now ("unmet medical needs"). IMET meets all criteria for advanced approvals. The EMA and the FDA are well aware of this desperate situation for blood cancer victims (ODD status in place) and are preparing advance approvals (logic tells us).

    Various descriptions of Imetetstat: 1. transformative cancer drug, 2. unprecedented remissions, 3. disease modifications never seen before (blood cancers), 4. saves lives, 5. safe to use, 6. enhanced effectiveness in combinations.-- (Previous)

    This is an outline of Imetelstat as part of any cancer program and Joe Biden's "cancer moonshot". Of course the FDA also knows this with all of the details. The "IMET Story" is almost complete. All that is needed is advanced approvals from the FDA or anyone of the 12 ASCO listed countries.

  • Reply to

    EU IMET approval sounds imminent

    by chad_dimplebutt Jun 18, 2016 10:53 AM
    sidesaddlex sidesaddlex Jun 18, 2016 11:43 AM Flag

    There are 12 countries with active sites for MF and MDS (around 100 sites with AML in the works). The EMA (EU) has 7 countries participating. The USA (FDA) is the most significant single country, with Israel being a sleeper. JNJ has diversified worldwide to cover all bets. Approvals from any of these 12 countries will move the PPS higher.

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

  • Reply to

    JNJ Understands Imetelstat (IMET)

    by lws2000 Jun 17, 2016 8:46 AM
    sidesaddlex sidesaddlex Jun 18, 2016 9:22 AM Flag

    Almost everyone seems to be in agreement that IMET works with "disease modifying properties" and about its uniqueness (remissions, potential cures, life saving, safe, etc). Much of this board's discussion is about Dr. S, and his importance at this time. He is a stock holder, an investor, and an associate of JNJ's. He is not on the "author's list, and is not an important force at this point in time. JNJ is in total control, and Dr. S is a subordinate.

  • Reply to

    JNJ Understands Imetelstat (IMET)

    by lws2000 Jun 17, 2016 8:46 AM
    sidesaddlex sidesaddlex Jun 18, 2016 12:39 AM Flag

    These are some of the oncologists and scientists that wrote the IMET story.
    *******************************************************************
    Citation:
    J Clin Oncol 34, 2016 (suppl; abstr TPS7079)--ASCO June 6, 2016

    Author(s): Ayalew Tefferi, Naseema Gangat, Dietger Niederwieser, Jan Van Droogenbroeck, Maria R. Baer, Jean-Jacques Kiladjian, Ronald Hoffman, Guido Finazzi, Francisco Cervantes, Jason R. Gotlib, Shireen Sirhan, Jane Apperley, Angélique Langlois, Ying Wan, Laurie Jill Sherman, Souria Dougherty, Faye Feller, Olatoyosi Odenike; Mayo Clinic, Rochester, MN; University of Leipzig, Leipzig, Germany; AZ Sint-Jan AV Brugge, Brugge, Belgium; University of Maryland Greenebaum Cancer Center, Baltimore, MD; Hôpital Saint-Louis & Université Paris Diderot, Paris, France; Tisch Cancer Institute, Mount Sinai School of Medicine, New York, NY; Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy; Hospital Clínic, IDIBAPS, University of Barcelona, Barcelona, Spain; Stanford University School of Medicine/Stanford Cancer Center, Stanford, CA; Jewish General Hospital, Montreal, QC, Canada; Centre for Haematology, Imperial Collegel, London, United Kingdom; Janssen Research & Development, LLC, Raritan, NJ; University of Chicago, Chicago, IL

  • Reply to

    JNJ Rarely Makes a Mistake; "IMET Story"

    by sidesaddlex Jun 15, 2016 8:31 PM
    sidesaddlex sidesaddlex Jun 16, 2016 8:04 PM Flag

    The "disrupters" have this board.

  • Reply to

    JNJ Rarely Makes a Mistake; "IMET Story"

    by sidesaddlex Jun 15, 2016 8:31 PM
    sidesaddlex sidesaddlex Jun 16, 2016 7:27 PM Flag

    IN JNJ WE TRUST

  • JNJ rarely makes a mistake and is in control. The fact that they have put so much time and effort (trials, resources) into IMET means that they know that they have a "transformative" cancer medicine. The time should be short now. Perhaps the EMA will approve in less than a month, with the FDA not far behind.

    The EMA and the FDA both have granted ODD status for IMET, which is a form of approval, and allows JNJ considerable flexibility in its numerous trials in the USA and Europe. The FDA and EMA will continue the "IMET Story".

  • Reply to

    IMET Works?

    by blackmarango Jun 14, 2016 9:18 AM
    sidesaddlex sidesaddlex Jun 14, 2016 10:22 AM Flag

    There is no question that IMET works. ASCO focused on IMET, and patients' needs now ("unmet medical needs"). IMET meets all criteria for advanced approvals. ("Thumbs down" seems to have nothing to do with IMET, but is indicative of the "Black Cloud" that follows you.)

    Various descriptions of Imetetstat: 1. transformative cancer drug, 2. unprecedented remissions, 3. disease modifications never seen before (blood cancers), 4. saves lives, 5. safe to use, 6. enhanced effectiveness in combinations.-- (Previous)

    This is an outline of Imetelstat as part of any cancer program and Joe Biden's "cancer moonshot". Of course the FDA also knows this with all of the details. The "IMET Story" is almost complete. All that is needed is advanced approvals from the FDA or anyone of the 12 ASCO listed countries.

  • ASCO focused on IMET, and patients' needs now ("unmet medical needs"). IMET meets are criteria for advanced approvals.

    Various descriptions of Imetetstat: 1. transformative cancer drug, 2. unprecedented remissions, 3. disease modifications never seen before (blood cancers), 4. saves lives, 5. safe to use, 6. enhanced effectiveness in combinations.-- (Previous)

    This is an outline of Imetelstat as part of any cancer program and Joe Biden's "cancer moonshot". Of course the FDA also knows this with all of the details. The "IMET Story" is almost complete. All that is needed is advanced approvals from the FDA.

  • ASCO focused on IMET, and patients' needs now ("unmet medical needs").

    Various descriptions of Imetetstat: 1. transformative cancer drug, 2. unprecedented remissions, 3. disease modifications never seen before (blood cancers), 4. saves lives, 5. safe to use, 6. enhanced effectiveness in combinations.-- (Previous)

    This is an outline of Imetelstat as part of any cancer program and Joe Biden's "cancer moonshot". Of course the FDA also knows this with all of the details. The "IMET Story" is almost complete. All that is needed is advanced approvals from the FDA.

  • sidesaddlex sidesaddlex Jun 13, 2016 9:14 AM Flag

    This board seems to be having problems, or it has changed is format again.

  • sidesaddlex sidesaddlex Jun 12, 2016 8:23 PM Flag

    Various descriptions of Imetetstat: 1. transformative cancer drug, 2. unprecedented remissions, 3. disease modifications never seen before (blood cancers), 4. saves lives, 5. safe to use, 6. enhanced effectiveness in combinations.-- (Previous)

    This is an outline of Imetelstat as part of any cancer program and Joe Biden's "cancer moonshot". Of course the FDA also knows this with all of the details. The "IMET Story" is almost complete. All that is needed is advanced approvals from the FDA.

  • These are still the questions, but the answers are not complete, since JNJ is still collecting and organizing the results form their many trial sites. The news from ASCO contains no negatives. Unmet medical needs has to be addressed by the FDA, since IMET has so many good characteristics.

    1. JAK compared to IMET (remissions, infusions, disease modification)
    2. Unmet medical needs (IMET safe, unique for blood cancers, needed now)
    3. The Dr. Tefferi connection (Mayo Clinic and Janssen-JNJ) and endorsements worldwide
    4. Status of FDA and other worldwide approvals beyond ODD (USA & EU)
    5. IMET potential and the road to ASH2016 (Journals like NEJM, other health conferences, continuing data from Janssen-JNJ trials---MF, MDS, AML)

    From ASCO poster (partial answers)--IMET is superior to JAK, and is the "last hope" when JAK fails. The "unmet medical needs" are the #1 patient considerations, only met by IMET for MF (and other blood cancers). Dr. Tefferi is on top of his game (Mayo Clinic & Janssen). The FDA and other worldwide agencies need to "up" their approvals for IMET. The IMET/JNJ trials are continuing and expanding (number and scope) worldwide, as new information evolves.

  • Reply to

    JNJ, FDA, Imetelstat--New Approvals

    by lws2000 Jun 12, 2016 7:09 AM
    sidesaddlex sidesaddlex Jun 12, 2016 12:20 PM Flag

    These are still the questions, but the answers are not complete, since JNJ is still collecting and organizing the results form the many trial sites. The news from ASCO contains no negatives.

    1. JAK compared to IMET (remissions, infusions, disease modification)
    2. Unmet medical needs (IMET safe, unique for blood cancers, needed now)
    3. The Dr. Tefferi connection (Mayo Clinic and Janssen-JNJ) and endorsements worldwide
    4. Status of FDA and other worldwide approvals beyond ODD (USA & EU)
    5. IMET potential and the road to ASH2016 (Journals like NEJM, other health conferences, continuing data from Janssen-JNJ trials---MF, MDS, AML)

    From ASCO poster (partial answers)--IMET is superior to JAK, and is the "last hope" when JAK fails. The "unmet medical needs" are the #1 patient considerations, only met by IMET for MF (and other blood cancers). Dr. Tefferi is on top of his game (Mayo Clinic & Janssen). The FDA and other worldwide agencies need to "up" their approvals for IMET. The IMET/JNJ trials are continuing and expanding (number and scope) worldwide, as new information evolves.

  • sidesaddlex sidesaddlex Jun 11, 2016 8:48 AM Flag

    Various descriptions of Imetetstat: 1. transformative cancer drug, 2. unprecedented remissions, 3. disease modifications never seen before (blood cancers), 4. saves lives, 5. safe to use, 6. enhanced effectiveness in combinations

    This is an outline of Imetelstat as part of any cancer program and Joe Biden's "cancer moonshot". Of course the FDA also knows this with all of the details.

  • JNJ controls IMET (trials, manufacturing, development, distribution). Janssen is JNJ's oncology division, and Geron is JNJ's junior partner. ASCO and Dr. Tefferi told us that Janssen is running trials for IMET in almost 100 places in 12 countries on 3 continents (North America, Europe, Asia). The emphasis is now on "unmet medical needs" (from ASCO poster).

    The FDA and other worldwide agencies are on onboard with ODD approvals, with advanced approvals on the radar screen. With continuing medical successes, plus JNJ technical knowhow and financial depth, IMET is a guaranteed success. The IMET medical science (Nobel Prize, Mayo Clinic successes, JNJ ever expanding trials) far exceeds Geron's PPS which is still under $3 and manipulated. JNJ is not asleep at the wheel, with trials being completed and new ones starting. The "IMET story" is unfolding in 2016 (ASCO to ASH).

GERN
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