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Amgen Inc. Message Board

rob_cos 57 posts  |  Last Activity: 17 hours ago Member since: Dec 31, 1997
  • Just out Options2Weatlh article" XON & ZIOP: Fundamentals & Stock Technicals Dancing In Unison!"..

    I tried to post but autodeleted probably because it had a link - see investorvillage ZIOP or XON board for full article, all the charts, the links and also the fundamental comments about the next 12 days

  • New Options2Weatlh article out " XON And ZIOP: Company Fundamentals And Stock Technicals Are Dancing In Unison!"....

    Tried to post but auto deleted it - you MUST read this full article ASAP - go to investorvillage ZIOP board to see it and the technical charts and fundamental comments about the next 12 days

  • ignore the newly minted basher...the need new names as they have been so wrong. HUGE option volume today - ASH will prove Sleeping Beauty is for real - an IL-12 deal is coming by JPM....TCR is attracting Roche, GSK, KITE, JUNO others - shorts are in trouble

  • Over 6200 Dec 14 calls bought mostly at ask ...1500 other Dec strikes bought as well.....

    ASH and SABCS coming in focus...

  • Pssst.....ZIOP can insert IL-12 in brain inert ("off")...we can then cross the Blood/Brain Barrier & regulate IL-12 in brain - no one else can....

    soon we will prove we can titrate IL-12 in the brain and breast - something the shorts and the scientific community said could never be done.

    Oh and by the way the guy from Stanford - the "expert" who said Sleeping Beauty won't work....the basis for more than half of the short interest in ZIOP.....guess what he is COMPLETELY WRONG - and that is about to be disclosed to all....he and the shorts who follow him blindly have not talked to Dr Cooper/Dr Emtage enough and have not done NEARLY enough due diligence to backup there short position

    Just an absolutely amazing result in very early Glioma trial...but it is only the beginning....we are in the bottom of the first and Dr Cooper and Dr Emtage are batting cleanup - the best duo in all of immunotherapy.

  • Griffin Securities Equity Research

    Intrexon Corporation November 20, 2015
    12 mos. Target Price $65.0
    Intrexon Corporation BUY
    Company Update : Biotechnology
    A New GE Emerging
    Intrexon is positioned to become the General Electric of
    genetic engineering. GE was founded on the use of electricity
    for lighting initially. But it rapidly expanded into electric railroad
    engines through a merger and diversified into power generation
    and transmission and into electric motors for a variety of
    industries. We believe Intrexon is on a similar path based on
    its foundational technologies in genetic engineering. Much like
    electricity, this new technology can be applied to applications
    that are completely unrelated, except through the underlying
    technology’s ability to achieve a desired outcome. The following
    are a few snippets from the recent Investor Day that we think
    underscore the diverse uses to which genetic engineering can be
    applied in a safe and commercially viable manner:

    ■ Ziopharm is preparing to initiate several clinical trials of
    immunotherapies. The partners have an IL-12 gene therapy in
    clinical studies, one of which has yielded favorable safety data
    in treating primary brain cancer. Clinical development of CART
    cells for hematological malignancies will soon advance and
    other therapies targeting solid tumors are nearing human trials.

    ■ Sun Pharma plans to submit an IND for a gene therapy
    in the second half of 2016. The major drug company based
    in India has a joint venture with Intrexon for the development
    of ophthalmic therapies. The first is a gene therapy under
    RheoSwitch control designed to treat wet age-related macular
    degeneration.

    ■ The pilot plant for the methane-to-isobutanol project will
    start up soon. Major improvements in yield have been achieved
    recently that should contribute to the plant’s success. Favorable
    results will lead Dominion Resources to begin construction of a
    small-scale commercial plant in 2016 or 2017.

    ■ Sales growth at the Oxitec, Okanagan, and AquaBounty
    subsidiaries should accelerate markedly in 2017. A
    commercial production facility for OX513A mosquitos will be
    built next year and recently planted orchards should begin
    yielding large volumes of Arctic apples in 2017. With FDA
    approval of the AquAdvantage salmon in hand, capacity will
    likely be added next year as well.

    We believe XON shares merit a BUY rating and a price target
    of $65. Indeed, the aforementioned advances augur well for free
    cash flow growth over the next five years.

    .

    NEAR-TERM NOTEWORTHY HAPPENINGS
    The following are events mentioned in the Investor Day presentations that will likely have a bearing on Intrexon’s
    future financial performance:
    Q4,’15 Ziopharm Oncology presentations on IL-12 gene therapy for glioma and breast cancer
    Q4,’15 Ziopharm Oncology presentations at the Annual Meeting of the American Society for Hematology
    Q4,’15 Completion of pilot plant for conversion of methane to isobutanol
    H2,’16 Submission of an IND by Sun Pharma for wet AMD gene therapy
    2016 Initiation of clinical trials of Ziopharm immunotherapies for various cancer indications
    2016 Expansion of production capacity for Okanagan Arctic apples and Oxitec’s OX513A mosquitos
    2016/17 Site selection for small-scale isobutanol production plant
    2017 Submission of an IND by Xogenex for a congestive heart failure gene therapy

    BASIC TECHNOLOGIES
    Intrexon’s Investor Day presentations provided an opportunity to learn about new technologies, such as gene switches and activator ligands similar to the RheoSwitch. (See Figure 1.) Another presentation focused on the use of artificial intelligence to integrate genetic and cellular information across the entire corporation and to simulate metabolic pathways under different constraints in silico to optimize a design before actually engineering it. The analysis reduces development time and costs, and it can even aid in assessing the commercial viability of a pathway by computing the expected yield of a desired compound. The really exciting aspect of Intrexon’s informatics systems is that it becomes increasingly effective through practical applications of the design-build-test-learn paradigm. As a result, its ability to design new, optimally effective pathways should grow exponentially.

    Figure 1. Intrexon’s Genetic Engineering Technologies
    Different applications of Intrexon’s technologies are helping to create new therapeutic agents, including gene therapies employing viral, non-viral, and cell-based delivery systems. Two interesting approaches that are under investigation are micro RNAs controlled by the RheoSwitch to tightly regulate entire cellular pathways in plants, animals, and man. Another approach involves designing modified proteins to modulate their stability and clearance, nd in doing so, alter their activity and/or toxicity. These techniques may be applied to projects under way with Ziopharm, Merck KGaA, the National Cancer Institute, and MD Anderson Cancer Center to address autoimmune diseases, cancer, and infections. A wide variety of host cells have been engineered using Intrexon’s technologies for the five major commercial sectors it is targeting, as shown in Figure 2.

    ZIOPHARM ONCOLOGY
    As shown in Figure 3, Ziopharm has numerous projects that will be under development in 2016, while three programs, two involving a RheoSwitch gene therapy expressing interleukin-12 (Ad-RTS-IL-12) and the third being CD19-directed CAR T-cells, will continue. Two clinical trials of the IL-12 gene therapy will report data shortly. On Saturday, November 21st, the company will present data from an ongoing Phase 1 trial that is enrolling patients with advanced glioma (brain cancer). The goal is to determine the safety and tolerability of Ad-RTS-IL-12 activated by veledimex, the activator ligand. Secondary endpoints include determining the maximum tolerated dose, immune responses, and biological response. Data from a Phase 1b/2 study of the IL-12 therapy involving women with advanced breast cancer will be reported at the San Antonio Breast Cancer Symposium that will be held December 9 – 12. Probably the most important data will be resented at the Annual Meeting of the American Society of Hematolog ythat will be held December 5 – 8. The trial has enrolled patients with advanced non-Hodgkin’s lymphoma or acute lymphoblastic leukemia. All patients received CD19+ CAR T cells prepared from donor cells after undergoing hematopoietic cell transplantation. According to the published abstract, 48% of the patients remained alive in complete remission at a median 5.2 months following the CAR T cell infusion.1 The study also demonstrated the feasibility of employing donor-derived lymphocytes to prepare CAR T cells, since graft-vs-host disease did not appear increased and the allogeneic T cells appeared to contribute to a reconstitution of the immune system and to protect against an opportunistic viral disease, cytomegalovirus infection.

    Figure 3. Ziopharm Immunotherapy Pipeline
    1 Kebriaei, P, et al. Pre-emptive donor lymphocyte infusion with CD19-directed, CAR-modified T cells infused after allogeneic hematopoietic
    cell transplantation for patients with advanced CD19+ malignancies. Abstract #862 of the 2015 American Society of Hematology Annual
    Meeting.

  • First of all it should be noted that Intrexon synthetically made IL-12. It was injected into the brain in the off position and activated with the veledimex switch.
    That has never been done before, and now it is proven in humans. Think platform technology.
    " Ad-RTS-IL-12 and veledimex demonstrated tightly controlled expression of the potent immune cytokine interleukin-12. "
    The side effects of IL-12 are well know - death.
    Just Google Dr Rosenberg from NCI and read about the potential of IL-12
    The companies ( XON/ZIOP) can't say this because its to early. However ...
    The study shows - 100% survival at approximately 150+ days or 5 months ( 5 patients were dosed in June)
    No deaths reported ( they must be reported within 24 hours )
    " No significant adverse clinical signs observed "
    From the poster - we can conclude that the platform is safe and effective
    "Ad-RTS-hIL-12 + veledimex administered in patients undergoing tumor resection was well tolerated "
    "Toxicity to date appears consistent with “on target” effect "
    Veledimex crosses the blood brain barrier " shorts said can't be done
    "Intra-cranial administration of Ad-RTS-hIL-12 is activated by oral veledimex " - proves the switch works in humans. In the human brain no less.
    The platform is regulate
    "Transcribed IL-12 peaked at Day 3 followed by downstream IFN γ "
    See poster below on Ziopharm website

    Notes from Dr Sam Broder at Stifel conference -
    Intrexon is a platform technology
    We have the solution - we harness a whole new paradigm
    We are taking the immune system which has failed the patient and reprogramming it ...
    We harness the immune system which will ultimately lead to a cures
    We control expression
    This will lead to enduring efficacy and scaleability
    No systemic effects

    Look at the quality of the institutions who have signed on to conduct trials- The best Dr's and hospitals in the world
    Summary -
    Wall Street probably sees this data as a yawn because they don't get the importance of controlling IL-12. See Dr. Rosenberg about importance.
    However - this validates the rheo-switch.
    The rheo-switch could be operating system for gene therapy in all human therapeutics.

    Sentiment: Strong Buy

  • Reply to

    Frm rob_cos "Yawn before the Deal...Part 2

    by hopewillhelpyou Nov 20, 2015 6:58 AM
    rob_cos rob_cos Nov 20, 2015 9:53 AM Flag

    Thanks I tried to post article and links and yahoo deleted....so this is an important post - to read the whole thing yahoo readers should go to the ZIOP message board on investorvillage message number 34601

  • Advanced Immunotherapies in the Queue

    Ziopharm Oncology and M.D. Anderson are laying the foundation for future adoptive cell therapies. The Company’s CEO, Dr. Laurence Cooper, remains in charge of his lab at the cancer center where his team is defining the properties of safe and effective therapies for clinical evaluation.

    Multiple strategies are under investigation to widen the therapeutic index of treatments in the R&D pipeline. One report showed that a receptor’s binding strength may be used to differentiate between a cell overexpressing a tumor associated antigen and a normal cell expressing the biomarker at a low level. In other words, an intermediate binding strength has the potential to minimize toxicity without impairing efficacy. This design complements earlier work that demonstrated the feasibility of producing T cells lacking endogenous T-cell receptors. Combined, the two studies should reduce the potential for graft-versus-host disease. Several alternatives are also being considered to avoid a safety issue called cytokine storm. CAR T cells may be used as an adjuvant to hematopoietic stem cell therapy for hematological cancers; for solid tumors, surgery or an alternative treatment may be appropriate prior to CAR T cell therapy; and other safety measures may include controlling CAR expression or CAR T cell activation. Finally, we note that Ziopharm is also preparing to test CAR T cells that express a cytokine, such as interleukin-12 or -15, to enhance their effectiveness and/or persistence in vivo.

    Several events should increase excitement in the months ahead. The Company will be presenting at six scientific meetings before year end, and up to five CAR T-cell therapies will be in clinical development. Besides any studies that Merck-Serono might initiate, clinical trials are under way to evaluate CARs for leukemia and lymphoid cancers, and a next-generation CD19CAR. Future clinical trials will test broad range of adoptive cell therapies. Among the cells that may enter clinical trials in 2016 are CAR T cells with a controllable cytokine (i.e., IL-12 or IL-15), a CAR targeting myeloid malignancies, a CAR for myeloid malignancies and solid tumors, off-the-shelf T cells, engineered T-cell receptor therapies, and NK cells.

    Ziopharm shares are on our recommended list. We believe presentations based on the trials of the intra-tumoral IL-12 gene therapy Ad-RTS-IL12 and clinical data from CAR T-cell studies will drive the Company’s valuation higher through 2016. The data may also lead to a partnering agreement(s) with a major pharmaceutical company. Meanwhile, Ziopharm has ample cash to support operations into 2018. We are affirming our BUY rating and $21 price target.

    Future clinical trials will test broad range of adoptive cell ther

  • See investorvillage ZIOP board for full article with links wont fit or copy here...

    "The Yawn That Led to The Deal" - Part 2 .......(or....."As Wall St slept.....partners scurry to close a deal with ZIOP/XON")........

    As Yogi Berra said "Its Deja Vu all over again" . Last Dec 3rd, ZIOP released breast/melanoma IL-12 data & other news....and last yr wall street (like today) quickly yawned at the press release and related data....but while Wall St yawned, MD Anderson immediately went to work to close a deal with ZIOP/XON....

    Recently my good friend Karim/BiosOrBust/Options2Wealth released "The Chuckle That Lifted The Veil" gleaning key messages sent by new ZIOP CEO Dr Cooper's first ever public presentation at the Wells Fargo Conference. If you have not read it - do so now - if you did read it...read it again.
    Now I have a follow up phrase "The Yawn That Led to The Deal" - Part 2

    About one one yr ago, on December 3, 2014, ZIOP released Clinical and Preclinical Data from Immuno-Oncology Programs at the AACR Tumor Immunology and Immunotherapy Meeting. By all measures the data was exciting showing “potent, systemic anti-cancer immune activity and control of both immune- and IL-12-mediated toxicity established in heavily pretreated breast cancer and melanoma patients”

    Now had this been KITE, JUNO or BLUE….the related stock likely would have gone up $8 day one and followed up with a $5 second day run…..but its ZIOP and WALL STREET YAWNED….the day of the press release the stock went DOWN 37 cents or 9% - the next day it rebounded a whole 12 cents….YAWN…..


    But as Wall Street yawned, MD Anderson (who was in the middle of discussions with RJ Kirk and Jon Lewis as part of one of Kirk’s “significant transactions underway” disclosed just weeks before during the XON Q314 earnings call – was pouring over this “yawnable” data – and if you talk to Cooper and others you will hear that MDA saw it as one of the key things that made them want to sign/close with XON/ZIOP in

  • Ziopharm Oncology and M.D. Anderson are laying the foundation for future adoptive cell therapies. The Company’s CEO, Dr. Laurence Cooper, remains in charge of his lab at the cancer center where his team is defining the properties of safe and effective therapies for clinical evaluation.



    Multiple strategies are under investigation to widen the therapeutic index of treatments in the R&D pipeline. One report showed that a receptor’s binding strength may be used to differentiate between a cell overexpressing a tumor associated antigen and a normal cell expressing the biomarker at a low level. In other words, an intermediate binding strength has the potential to minimize toxicity without impairing efficacy. This design complements earlier work that demonstrated the feasibility of producing T cells lacking endogenous T-cell receptors. Combined, the two studies should reduce the potential for graft-versus-host disease. Several alternatives are also being considered to avoid a safety issue called cytokine storm. CAR T cells may be used as an adjuvant to hematopoietic stem cell therapy for hematological cancers; for solid tumors, surgery or an alternative treatment may be appropriate prior to CAR T cell therapy; and other safety measures may include controlling CAR expression or CAR T cell activation. Finally, we note that Ziopharm is also preparing to test CAR T cells that express a cytokine, such as interleukin-12 or -15, to enhance their effectiveness and/or persistence in vivo.

    Several events should increase excitement in the months ahead. The Company will be presenting at six scientific meetings before year end, and up to five CAR T-cell therapies will be in clinical development. Besides any studies that Merck-Serono might initiate, clinical trials are under way to evaluate CARs for leukemia and lymphoid cancers, and a next-generation CD19CAR.

    Future clinical trials will test broad range of adoptive cell therapies. Among the cells that may enter clinical trials in 2016 are CAR T cells with a controllable cytokine (i.e., IL-12 or IL-15), a CAR targeting myeloid malignancies, a CAR for myeloid malignancies and solid tumors, off-the-shelf T cells, engineered T-cell receptor therapies, and NK cells.

    Ziopharm shares are on our recommended list. We believe presentations based on the trials of the intra-tumoral IL-12 gene therapy Ad-RTS-IL12 and clinical data from CAR T-cell studies will drive the Company’s valuation higher through 2016. The data may also lead to a partnering agreement(s) with a major pharmaceutical company. Meanwhile, Ziopharm has ample cash to support operations into 2018. We are affirming our BUY rating and $21 price target.

  • ZIOP upgraded by crowdsourcing site VETR $21.50 target

    see Investorvillage ZIOP message board for link wont post on yahoo

  • You must read the new Option2Wealth blog analyzing by slide with full transcript of CEO DR Cooper of ZIOP - can't fit here or post seeking alpha link so here is just the beginning - go to investorvillage CELG board to see full article and slides in color..

    Being a ZIOP bull, I, like other bulls, attentively listened to CEO Dr. Laurance Cooper's presentation at the Intrexon's Investor Day shindig last week...Actually I listened to it a couple of times...Then, I decided to have his presentation transcribed...for two reasons: 1) Reading the words allows me to comprehend and appreciate the presentation better, and 2) Since the recording of the webcast is only available for 30 days, I wanted to preserve a verbatim record here for future referencing...and I gotta tell ya, re-listening Dr. Cooper's talk, while simultaneously reading his presentation, gave me a much greater appreciation for what the good Doctor said, and revealed...

    For those new to my blog, I want you folks to understand and appreciate the first important fact: Today, in the most exciting field in cancer research, many consider Dr. Laurence Cooper to be one of the world's foremost authorities on immuno-oncology, ...if not #1, then certainly he is one of the top 3 and ZIOPHARM is extremely fortunate that he is the company's CEO...No other company in the immuno-oncology space can boast of a CEO of similar stature!

    Another important fact that needs to be understood, and Dr. Cooper pointed this out in his presentation is that ZIOPHARM, because of its ground-breaking partnership with MD Anderson, now has access to years of clinical data that MD Anderson had been conducting in the field of immuno-oncology, and well before its partnership with ZIOPHARM...all that clinical data ZIOPHARM will be able to piggyback on and at a minimum, catch up with JUNO and KITE who have had a couple of years of headstart on ZIOPHARM. Dr. Cooper clearly points out that ZIOPHARM will be releasing some of that data as its own, at the upcoming ASH conference in early December. I cannot stress how important this fact is, and many, if not most folks in the investment community are not aware of...Because with the revealing of this data, and Dr. Cooper hinted, "we have therapeutic optimism," that the data is good, ZIOP will clearly have caught up with its two main competitors, JUNO and KITE, even though, chronologically, it was late to the party!

    Before I share the entire transcription of Dr. Cooper's November 12th, 2015 presentation, along with the relevant slide(s), and in the appropriate order, I will first highlight a few salient parts of his talk...

    1) ZIOPHARM's Technology and Capability:

    i) "Ability to generate cells, NK cells and T-cells, outside of the body, and infuse them into patients. This is done by us in two broad categories: patient-derived cells going into their recipient and donor-derived cells coming from another person, going into the recipient. And those donor-derived cells at the moment come from a match sibling or a match family member, but increasingly, you'll see us starting to put in third-party cells those off-the-shelf applications."

    ii) "We can deliver a very potent drug and importantly activate the drug through an oral ligand but also turn off the drug with an oral ligand. Many companies can turn on genes, it's very difficult to turn off genes. It is the on-off regulatory switch that is the critical differentiating component."

    2) Multi-Center Clinical Trials:

    "ZIOPHARM already undertakes a multi-center gene therapy program. This is -- there's a pause here. This is actually a significant effort by us. There are very few companies right now in the United States that do multi-center gene therapy trials, and we do it. To do this we are essentially now entreating patients who have advanced glioblastoma, a brain tumor. This is a lethal moment in this person's disease narrative, and we are instilling into that brain tumor the weaponized adenovirus for the on-off delivery of IL-12 and you'll see this data submitted in just a few weeks now to the Society of Neuro-Oncology."

    Clinical Data: "We are a-l-r-e-a-d-y in the clinic, and we have therapeutic optimism about what our data are for glioma and breast."

    On CD-19: "We already have clinical data. These work stems from my work when I was at MD Anderson just a few short months ago in May of this year. Now we finished these clinical trials we will report on this officially at ASH in December of this year."

    "We've followed these patients now for two years, and 86% of these patients now are in remission. We have also now infused T-cells that come from a third party. This is a match sibling or a family member. When those cells are weaponized to have that chimeric antigen receptor they are infused, and in this situation, about 60% of patients with ALL now have long-term remission, and interestingly, this is kind of a nuance to the field that we get at ASH, three-quarters of the patients who have had a haplo transplant are also in remission."

    Off-The-Shelf Treatments to Help Reduce Treatment Cost: "You'll see us starting to put in third-party cells those off-the-shelf applications."

    "And then the off-the-shelf, of course, because underlying all of this is the ability to get products into patients and to do it at low cost, because if the cost structure is excessive it will remain a boutique. So, part of what we do, is not only do excellent science, but keep our eye on the fundamentals so that this biology will be available to many."

    I think this is pretty heady stuff!

  • Raymond James-Take that Kyle Bass – CELG Prevails in Patent Challenge-Strong Buy-Target $161

    Raymond James
    Celgene Corporation
    STRONG BUY

    TARGET $161.00

    Take that Kyle Bass – CELG Prevails in Patent Challenge

    Recommendation: Remain Strong Buy-rated on CELG shares. Today’s ruling by the USPTO reinforces the Celgene patent estate by blocking off yet another attack by hedge fund manager Kyle Bass. While we remain unclear on Bass’s strategy, we view the USPTO’s decision as further validation of the strength of Celgene’s patent estate. Combining our confidence on this front, with management’s recent guidance raise, additional catalyst flow ahead and attractive valuation (~19x 2016 consensus EPS versus 21x peers), and we would continue to recommend purchase of CELG.

    USPTO denies hedge fund attack on CELG’s Revlimid ‘517 patent. This afternoon the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board ruled in favor of Celgene in an ongoing case against hedge fund manager Kyle Bass’ Coalition for Affordable Drugs. The PTAB declined to institute an inter partes review of U.S. patent #5,635,517, on the grounds that they disagreed with Bass’ arguments on nonobviousness (link to document). Clearly, a nice win for Celgene over Bass.

    Important victory today, broad patent portfolio remains in place. Although IPRs were instituted by Bass for other Celgene patents, today’s win is important in its own right in that the ‘517 patent is a key composition of matter patent providing protection for Revlimid into October 2019. Recall, Celgene is currently engaged in a patent infringement case with Allergan (Natco) with discovery recently extended into January 2016 (from November 2015). For our part, we continue to think Celgene’s patent estate offers broad protection out to 2028, with multiple Orange Book listed patents.

    More catalysts ahead, starting with ASH in December. With a number of collaborations ongoing

    Sentiment: Strong Buy

  • CELG just won key patent IPR ruling over Kyle Bass. Analyst reports to come good for IBB too

    CELG 517 Not Instituted

    Published by iphawk
    CELG 517 Not Instituted
    See more

    v Paper 22 Tel: 571-272-7822 Entered: November 16, 2015 UNITED STATES PATENT AND TRADEMARK OFFICE _______________ BEFORE THE PATENT TRIAL AND APPEAL BOARD _______________ COALITION FOR AFFORDABLE DRUGS VI LLC, Petitioner, v. CELGENE CORPORATION, Patent Owner. _____________ Case IPR2015-01169 Patent 5,635,517 ______________ Before TONI R. SCHEINER, JACQUELINE WRIGHT BONILLA, and TINA E. HULSE,

    Administrative Patent Judges.
    BONILLA,
    Administrative Patent Judge

    . DECISION Denying Institution of Inter Partes
    Review
    37 C.F.R. § 42.108

  • First 57 slides mostly all health/cancer related with Dr Reed, Dr Broder, Dr Cooper, Dr Emtage, Dr Suma Krishan all speaking!!

  • rob_cos rob_cos Nov 12, 2015 12:21 PM Flag

    He obviously knows ZIOP and XON are going much higher next couple of weeks months. Many catalysts on ZIOP side.

AMGN
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