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Roche Holding AG Message Board

lws2000 240 posts  |  Last Activity: 13 hours ago Member since: Nov 21, 2001
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  • Reply to

    Did it again

    by rahdbob3 Jun 15, 2015 3:41 PM
    lws2000 lws2000 Jun 15, 2015 4:42 PM Flag

    I think you will be OK. This is a tug-of-war between the hedge funds & JNJ/Janssen. The hedge funds will lose, IMO.

  • Reply to

    Something seems Fishy here...

    by lavery1965 Jun 15, 2015 2:48 PM
    lws2000 lws2000 Jun 15, 2015 3:16 PM Flag

    There was an article in a Sep. 2014 issue of the Washington Post about how small biotech firms are manipulated. Geron is part of that basket. Since these hedge funds do not discriminate, the fact that Geron and JNJ are now partners, makes no difference to them. Geron has to break loose from the basket.

  • "The granting of an orphan designation request does not alter the standard regulatory requirements and process for obtaining marketing approval. Safety and effectiveness of a drug must be established through adequate and well-controlled studies." (from FDA)

    It appears that Imetelstat (IMET) is one step away from breakthrough-therapy. As an orphan-drug, it has received an accelerated-approval, which brings many developmental benefits benefits, including availability to MF patients. The FDA is now cooperating and coordinating with JNJ/Janssen. The next step is breakthrough-therapy, since IMET has been proven "safe and effective" by Mayo Clinic. JNJ/Janssen is going global (36 sites and counting) to reinforce and improve upon the Mayo data. Orphan drug status is now likely for all of the blood cancer cousins (MF, MDS, AML).

    "BREAKTHROUGH THERAPY: This designation is similar to fast track designation, with one important difference — the evidence for benefit over available therapies must come from humans, not from laboratory experiments.
    ORPHAN DRUG DESIGNATION: This mechanism is designed to encourage development of drugs for certain types of diseases. Unlike the mechanisms above, orphan drug designation doesn’t hasten the review process, change the criteria for approval, or allow early access to a drug."

  • Reply to

    Orphan Drug Breakthrough for Imetelstat (IMET)

    by lws2000 Jun 14, 2015 1:57 PM
    lws2000 lws2000 Jun 15, 2015 7:22 AM Flag

    "The granting of an orphan designation request does not alter the standard regulatory requirements and process for obtaining marketing approval. Safety and effectiveness of a drug must be established through adequate and well-controlled studies."

    Since Mayo Clinic has already proven that, in MF patients, IMET is "safe and effective", the step from "orphan-status" to "breakthrough therapy" looks like a small one. JNJ/Janssen is going global (36 sites and counting) to reinforce and improve upon the Mayo data.

    "BREAKTHROUGH THERAPY: This designation is similar to fast track designation, with one important difference — the evidence for benefit over available therapies must come from humans, not from laboratory experiments.
    ORPHAN DRUG DESIGNATION: This mechanism is designed to encourage development of drugs for certain types of diseases. Unlike the mechanisms above, orphan drug designation doesn’t hasten the review process, change the criteria for approval, or allow early access to a drug."

  • lws2000 lws2000 Jun 15, 2015 7:09 AM Flag

    Comment on #2---"Likely induces similar results in other myeloid cancers (MDS/AML)."

    Now that we know that JNJ & the FDA are cooperating & are on the same page, that points to bringing IMET to all MF patient's in the USA and the rest of the world, the same status (Orphan-drug-status) is likely coming for MDS & AML. That means that IMET will be available for MF now, and both MDS and AML as off-label, similar diseases. JNJ/Janssen is a powerful force. There is no question that IMET is "safe & effective" (Mayo trials) which are the criteria to go from Orphan-status to Breakthrough-status. The new international trials will reinforce that.

  • Reply to

    Orphan Drug Breakthrough for Imetelstat (IMET)

    by lws2000 Jun 14, 2015 1:57 PM
    lws2000 lws2000 Jun 14, 2015 5:56 PM Flag

    "Safety and effectiveness of a drug must be established through adequate and well-controlled studies." This has already been established by the successful MF trials at Mayo Clinic, and will be reinforced by the multiple international trials that JNJ/Janssen is about to start. In addition, orphan status for MDS and AML, treated with IMET, is on the agenda.

    Now that "orphan-drug-status" for IMET is a fact, and no longer a distant hope, other "accelerated-approvals" will appear from all over the world. JNJ has designed these new international trials in a brilliant way, to put Jakafi into the proper perspective, in a one-on-one comparison with IMET. The FDA, while cautious in its dealings with the Old-Geron, has total confidence in the New-Geron (dated from JNJ partnership). The PPS of the New-Geron still trades independently from JNJ, but is totally influenced by JNJ.

  • Designating an Orphan Product: Drugs and Biological Products

    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.

    A sponsor seeking orphan designation for a drug must submit a request for designation to OOPD with the information required in 21 CFR 316.20 and 316.21. Each designation request must stand on its own merit. Sponsors requesting designation of the same drug for the same rare disease or condition as a previously designated product must submit their own data and information in support of their designation request. The granting of an orphan designation request does not alter the standard regulatory requirements and process for obtaining marketing approval. Safety and effectiveness of a drug must be established through adequate and well-controlled studies.

  • Reply to

    Recognizing Types of Shorts in the Wild

    by irishtrader52 Jun 14, 2015 9:47 AM
    lws2000 lws2000 Jun 14, 2015 11:50 AM Flag

    Thank you Irish----We are talking about two different times: 1. Before JNJ was a partner (BJ), 2. After JNJ became a partner (AJ). All of the Geron transgressions (real, invented and imagined), which existed in the BJ era, are of little or no consequence in the AJ era. JNJ is now running the show, and the FDA is now cooperating with them (liver holds gone, orphan drug status). The BJ-Geron could not please the FDA for many reasons, that include outside manipulation, hedge funds, and poor data collection methods. In the AJ era JNJ/Janssen leads, as the future of Imetelstat develops internationally.

  • lws2000 lws2000 Jun 14, 2015 7:26 AM Flag

    More comments on #6---" Data reported qualifies for accelerated, fast-track, BTD, and/or orphan drug status based on my personal amateur analysis. Due own due diligence."

    This has proved to be absolutely accurate. Now that "orphan-drug-status" for IMET is a fact, and no longer a distant hope, other "accelerated-approvals" will appear from all over the world. JNJ has designed these new international trials in a brilliant way, to put Jakafi into the proper perspective, in a one-on-one comparison with IMET. The FDA, while cautious in its dealings with the Old-Geron, has total confidence in the New-Geron (dated from JNJ partnership). The PPS of the New-Geron still trades independently from JNJ, but is totally influenced by JNJ.

  • Reply to

    Nothing Left To Hold Geron's PPS in Check

    by lws2000 Jun 13, 2015 3:33 PM
    lws2000 lws2000 Jun 13, 2015 5:35 PM Flag

    Clearly, the PPS of the New-Geron (from when JNJ became a partner) and the orphan-drug-status are related. The Old-Geron, for a number of reasons, could never get the FDA on their side. At some earlier time, Geron's credibility may have been an issue, as well as the quality and reliability of their data. JNJ/Janssen and their new associate (Dr. Tefferi) are about to conduct international trials that will be definitive, and designed to satisfy the FDA, and other global groups. The orphan drug status is a vote of confidence from the FDA, that IMET is needed now, is unique, is effective and is safe.

  • I believe, that IMET's new orphan-drug-status (for MF), will lead to fast track approval. JNJ's global initiatives should more than counter balance the efforts of the shorts, and the associated hedge funds, to keep the PPS in a channel under $5. We will see.

  • lws2000 lws2000 Jun 13, 2015 8:25 AM Flag

    Comment on #2--"Likely induces similar results in other myeloid cancers (MDS/AML)"

    Now that JNJ/Janssen has managed orphan-drug-designation for MF using IMET, that same approach can be used for the other myeloid blood cancer cousins. JNJ/Janssen has already told us that there are preparing trials for all three (a basket). They now have the FDA cooperating, as well as similar approval groups in other countries (Asia, Europe). IMET is in a class by itself (remissions, potential cures).

  • lws2000 lws2000 Jun 12, 2015 4:33 PM Flag

    "Orphan Drug Status" indicates that in the case one disease (MF), IMET is safe, effective, unique, and life-saving, according to the FDA. This is also likely for the other blood cancers (MDS, AML), and other cancers whose survival depends on their telomere length. The medical community is now able to offer IMET to MF patients, and beyond.

  • Reply to

    Question

    by wysgramps Jun 12, 2015 3:54 PM
    lws2000 lws2000 Jun 12, 2015 4:05 PM Flag

    This leaves the door open for Mayo Clinic to try IMET on all of the blood cancers (MF, MDS, AML) and other cancers.

  • lws2000 lws2000 Jun 12, 2015 2:31 PM Flag

    "9:59 am (6/12/15)---Geron lifting after JNJ's Janssen was granted FDA orphan designation for its imetelstat for the treatment of myelofibrosis (MF) -- GERN is parterned with Janssen for the drug (GERN)."

    This is the 1st approval of IMET, and should be very good for the PPS. Few expected such a quick approval for fast track status.

  • lws2000 lws2000 Jun 12, 2015 1:28 PM Flag

    The investing world is finally realizing that JNJ/Janssen, after reviewing all existing IMET data, is now going global with this medicine (1st MF, 2nd MDS, 3rd AML, 4th other cancers). JNJ has considerable resources and talent to focus on IMET and patients survivability, including remissions and cures.

  • lws2000 lws2000 Jun 12, 2015 9:35 AM Flag

    Comment on #8--" Partnership with subsidiary of world's largest pharmaceutical and established collaboration with Mayo Clinic Rochester"

    The credibility and competence of these two partners are beyond reproach. Mayo's initial trials for MF, with proven successes, and JNJ's reinforcement of Dr. Tefferi's original work, with more than 30 new global trials, is proof positive that they both believe a "very big" IMET future.

  • lws2000 lws2000 Jun 11, 2015 9:52 AM Flag

    There are no significant safety problems, and IMET offers durable remissions and possible cures. A book needs to be written about the market forces that are in complete control of the PPS. Of course, JNJ/Janssen and medical science will eventually dominate, but when?

  • lws2000 lws2000 Jun 11, 2015 7:10 AM Flag

    Comment on #4---" Minimal quality-of-life side effects (nausea, hair loss) and other suppressive effects easily managed."

    The liver-holds were the major safety factors that had damaged the Old-Geron, but after the FDA reviewed the Mayo Clinic data, all liver-holds were removed. Now, it is apparent, that they were ill-conceived in the first place. Cancer drugs, that are effective, are also very powerful. IMET is amazingly safe for a medicine that accomplishes so much. JNJ's new global trials (the New-Geron) will focus on dosage and safety, as well as symptom reduction, curability (unique to IMET), and overall responses.

  • lws2000 lws2000 Jun 10, 2015 10:51 PM Flag

    The results are in and Imetelstat is overwhelming the only choice. The Mayo Clinic successes are a matter of record. JNJ feels the necessity to conduct 30 more worldwide trials to repeat and improve upon the Mayo results. They must be very confident to invest so much time, money and talent in this "building-block" to control all cancers, with the blood cancer cousins coming first.

    Why has IMET not received advanced approval yet? There is something wrong with the process, and perhaps with the FDA. There have been many theories, with some blaming management. JNJ/Janssen is now in charge, so the mistakes of the past will likely be corrected very soon, with the needs of the patients finally coming first.

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