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   Biotech / MedicalGeron Corp.


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From: Savant4/5/2016 12:56:14 PM
   of 3523
 
Geron to Present at the Needham Healthcare Conference

MENLO PARK, Calif., April 05, 2016 (GLOBE NEWSWIRE) -- Geron Corporation (Nasdaq:GERN) today announced that John A. Scarlett, M.D., President and Chief Executive Officer, is scheduled to present at the 15th Annual Needham Healthcare Conference in New York at 8:40 a.m. Eastern Time on Tuesday, April 12, 2016.

A live webcast of the presentation will be available through the Investor Relations pages of Geron's website and at wsw.com. Following the live presentation, the webcast will be archived and available for replay at the same address for a period of 30 days.

About Geron

Geron is a clinical stage biopharmaceutical company focused on the collaborative development of a first-in-class telomerase inhibitor, imetelstat, in hematologic myeloid malignancies. For more information about Geron, visit www.geron.com.

CONTACT: Anna Krassowska, Ph.D. Investor and Media Relations 650-473-7765 investor@geron.com media@geron.com

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From: tktrimbath6/30/2016 6:10:56 PM
   of 3523
 
My mid-year review of GERN

INTRO Here's my semi-annual exercise to see if I remember why I own the stocks I own, and so I can check back and see if their stories have changed. I post in case it helps others too.

Geron
GERN (market cap was $0.766B EOY2015 is $0.426B mid2016)
Geron is a leading edge biotech, and has been for over a decade. While originally they were diversified across four major technologies, they have spun off three of them (see my notes about AST on InvestorVillage.com) and are reduced to working on a cancer treatment based on managing telomerase. While that may sound restrictive, telomerase potentially could treat multiple cancers; and because it controls cell growth and death, could possibly treat auto-immune diseases, as I understand it. The treatment is in clinical trials, but is years away from possible approval. If they succeed, and if the treatment works for more than the first targeted cancer, then the company may finally live up to its potential. Innovative treatments, however, have to deal with the non-innovative FDA approval process. Alternatively, such an important breakthrough could achieve a compassionate status. If successful, they will be challenging an entrenched cancer industry what will have billions of dollars in revenue at risk potentially sparking an immense corporate immune response (as was witnessed in Dendreon's successful prostate cancer vaccine.)

I have a sufficiently large holding that my finances would be significantly improved with the success of the stock, the treatment, and the company. There is entrenched support for the company as evidenced by the market cap of more than half a billion dollars. Such a high market valuation for an unproven treatment limits some of the upside potential because some of it is already priced in. After decades of waiting, it may only take a few more years for approval.

DISCLOSURE LTBH since 1999 and continuing to hold (though I sold much, partly for diversification, partly to raise funds.)
(I've also collected links to the other discussion boards and my other stocks over on my blog trimbathcreative.wordpress.com

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From: Savant7/26/2016 1:51:45 PM
   of 3523
 
RT...GERN was such an early pioneer... genengnews.com

Growing Old Gracefully: Male Hormone Reverses Cell Aging (Page 1 of 1)



  • Click Image To Enlarge +

    Researchers may have found a way to stimulate the cellular "fountain of youth" molecule. [NIH]
    The impact of the telomerase enzyme’s discovery cannot be overstated, as its importance to cell biology was recognized in 2009 with the awarding of the Nobel Prize in Physiology or Medicine. Over the years, researchers have come understand more closely the molecular mechanisms this protein utilizes during the cell cycle and maturation, leading it too often to be referred to as the “fountain of youth” molecule. Now, a recent study by investigators in the U.S. and Brazil has shown that male sex hormones can stimulate production of the telomerase enzyme—providing potential therapeutic avenues for various genetic diseases.

    This novel strategy was tested in with genetic diseases, such as aplastic anemia and pulmonary fibrosis, which have known mutations in the telomerase gene. The researchers believe that the approach they took in this new study may help combat the damage caused to patients by telomerase deficiency.

    "One of the processes associated with aging is a progressive shortening of telomeres, DNA-protecting structures at the ends of chromosomes, like the plastic tips on shoelaces," explained co-author Rodrigo Calado, M.D., Ph.D., professor at the University of São Paulo's Ribeirão Preto Medical School (FMRP-USP). "Each time a cell divides, its telomeres get shorter. Eventually, the cell can't replicate anymore and dies or becomes senescent. However, telomerase can keep the length of telomeres intact, even after cell division."

    Scientists often use telomere length as a laboratory measure of a cell's age. Interestingly, some cells avoid aging by using telomerase to lengthen their telomeres through the addition of DNA sequences, thereby maintaining their capacity to multiply and "stay young."

    Embryonically, where tissues are still in their formative stages, telomerase is expressed by practically every cell. After this period, only cells that are constantly dividing, such as hematopoietic (blood-forming) stem cells, which can differentiate into a variety of specialized cells, continue to produce telomerase.

    "Aplastic anemia is one of the diseases that can be caused by telomerase deficiency," Dr. Calado noted. "Bone marrow stem cells age prematurely and fail to produce enough red blood cells, white blood cells, and platelets, making the patient dependent on blood transfusions and more susceptible to infections."

    Previous work done by Dr. Calado and his colleagues showed that androgens, which are converted into estrogens in humans, bound to female hormone receptors in the telomerase gene promoter region and thereby stimulated expression of the enzyme in cells.

    "The study we've just published was designed to find out whether the effect we'd observed in the lab also occurred in humans, and the results indicate that it does," Dr. Calado remarked.

    The findings from this study were published recently in The New England Journal of Medicine in an article entitled “Danazol Treatment for Telomere Diseases.”

    Instead of estrogen, the researchers treated the patients with the androgen danazol, a synthetic male hormone, because it has long been used as a drug in cases of congenital anemia and offers the advantage of stimulating an increase in the mass of hemoglobin (red blood cells), which estrogen cannot do. Treatment with this steroid was tested for 2 years in 27 patients with aplastic anemia owing to telomerase gene mutations.

    "In a healthy adult, telomere length varies from 7000 to 9000 base pairs on average. A normal person's telomeres lose 50 to 60 base pairs per year, but a patient with telomerase deficiency can lose between 100 and 300 base pairs per year," stated Dr. Calado. "In the patients who received danazol, telomere length increased by 386 base pairs on average over 2 years."

    Additionally, the researchers found that hemoglobin mass rose from 9 grams per deciliter (g/dL) to 11 g/dL on average. A person without anemia normally has between 12 and 16 g/dL, but the improvement observed in these subjects was sufficient to rid them of transfusion dependency.

    "On completion of the protocol, the medication was interrupted, and we observed a fall in all counts. Several patients resumed the medication with smaller doses, individually adjusted to minimize side effects," Dr. Calado said.

    In a new protocol currently in progress at the University of São Paulo's Ribeirao Preto Blood Center, the same kind of approach is being tested with nandrolone, an injectable male hormone.

    While the results of the current study suggest that drugs can be used to reverse one of the biological drivers of aging, it is not yet clear whether the benefits of such treatment would surpass the risks in healthy people, especially if the treatment involves the use of sex hormones.


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    To: Savant who wrote (3478)8/4/2016 12:00:55 PM
    From: Savant
       of 3523
     
    RT... brain tissue grown from stem cells

    msn.com

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    From: Savant8/18/2016 1:06:14 AM
       of 3523
     
    RT..Corneas from stem cells..
    Lab grown corneas....now...& by Y10K...they'll be able to grow/make any body part..

    Stem cells>>

    msn.com

    More than 500 million people around the world are either visually impaired or blind, but thanks to a technique developed by a team of Japanese scientists at Osaka University, there may be hope for a new treatment. The breakthrough, published in the journal Advanced Healthcare Material, demonstrates their success in growing a key part of the eye in a petri dish — the cornea.The inside of your eye is a highly organized and complex system, composed of three basic layers that have an important function needed for visual processing, including the cornea as the outermost layer. These cells deteriorate with age, which is why figuring out how to regenerate CECs is the key to maintaining functional eyesight. All researchers need is a small sample of skin to regenerate corneal endothelial cells (CECs), which are responsible for keeping the window of the eye clear and preventing it from swelling.

    After growing CECs in a petri dish over the course of several weeks, researchers implanted them in sheep that were born without corneas. The sheep’s vision was restored to 98 percent. After 28 days, the sheep’s eyes didn’t reject the CECs or become inflamed, proving to the team their lab-grown corneas were near identical to that of one naturally grown. They have yet to implant them into humans, but once they do, it may open up a huge door for the visually impaired, who are in need of a medical procedure to regain their eyesight.

    “For years, we didn’t have anything to offer these patients — we’d transplant a cornea, it would work for a few weeks, then the blindness would return. It’s devastating,” Dr. Edward Holland, director of cornea services at the Cincinnati Eye Institute who was not involved in the study, said in an interview. “This takes the stem cell procedure to another level, giving us more options to offer patients.

    In preliminary trials earlier this year in March 2016, the same research team grew sheaths of corneas for rabbits. Sheets of petri-grown corneas were implanted into the eyes of blind bunnies. Once the stem cells took hold of the rest of the rabbits’ eyes, their eyesight was completely restored and researchers published their findings in the journal Nature. Beyond corneas, researchers hope to grow retinas, lenses, and other key components of the eye for those who were born with or developed visual impairment

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    From: Savant9/12/2016 9:17:34 AM
       of 3523
     
    Geron Provides Update on Imetelstat Trials Being Conducted by Janssen

    Conference Call Scheduled for 8:00 a.m. EDT Today, September 12

    MENLO PARK, Calif., Sept. 12, 2016 (GLOBE NEWSWIRE) -- Geron Corporation (Nasdaq:GERN) today provided updates on the clinical trials being conducted by Janssen Research & Development, LLC, of the telomerase inhibitor imetelstat. Planned internal reviews of initial data from both trials have been completed by Janssen, and both trials are continuing in order to evaluate additional and more mature data.

    IMbark(TM)

    IMbark(TM) (NCT02426086) was originally designed as a Phase 2 clinical trial to evaluate two dose levels of imetelstat (either 4.7 mg/kg or 9.4 mg/kg administered every three weeks) in approximately 200 patients (approximately 100 patients per dosing arm) with Intermediate-2 or High risk myelofibrosis (MF) who have relapsed after or are refractory to prior treatment with a JAK inhibitor. The co-primary efficacy endpoints for the trial are spleen response rate and symptom response rate at 24 weeks. To date, over 90 patients have been enrolled in the trial across both dosing arms.

    To inform an assessment of the appropriate dose and schedule for relapsed or refractory MF patients in IMbark(TM) , Janssen conducted a planned internal interim review of safety, efficacy and pharmacokinetic data from 20 patients from each dosing arm who have been followed on the trial for at least 12 weeks. Based on this first internal review at the early 12-week time point, the following has been determined by Janssen:

    -- The safety profile was consistent with previous imetelstat clinical trials in hematologic myeloid malignancies. No new safety signals were identified. -- Activity in the 4.7 mg/kg dosing arm does not warrant further investigation of that dose and this arm will be closed to new patient enrollment. An amendment to the trial protocol is planned to allow eligible patients in this arm to increase their dose to 9.4 mg/kg per investigator discretion. -- In the 9.4 mg/kg dosing arm, even though at the week 12 data assessment an insufficient number of patients met the protocol defined interim criteria, this arm warrants further investigation because encouraging trends in the efficacy data were observed. Patients already enrolled in this arm may continue to receive imetelstat. New enrollment in this arm will be suspended while the trial continues in order to obtain additional and more mature data that includes a longer follow-up of patients at 24 weeks, consistent with the co-primary efficacy endpoints. The number of patients enrolled to date is expected to be sufficient to inform potential future development of this dose. -- Janssen plans to conduct an additional internal data review in the second quarter of 2017 to include a longer follow-up of patients at 24 weeks. Potential outcomes of the second internal review at the 24-week time point could include resuming enrollment in the 9.4 mg/kg dosing arm, with or without changes to the dosing regimen; adding a new dosing arm; or closing the trial. -- Any protocol amendments will be subject to review by health authorities around the world. IMerge(TM)

    IMerge(TM) (NCT02598661) is a Phase 2/3 clinical trial evaluating imetelstat in transfusion dependent patients with Low or Intermediate-1 risk myelodysplastic syndromes (MDS) who have relapsed after or are refractory to prior treatment with an erythropoiesis stimulating agent (ESA). The clinical trial is in two parts: Part 1 is a Phase 2, open-label, single-arm design in approximately 30 patients and Part 2 is a Phase 3, randomized, double-blind, placebo-controlled design in approximately 170 patients. The primary efficacy endpoint is the rate of red blood cell transfusion-independence lasting at least 8 weeks. Part 1 of the trial is fully enrolled.

    Janssen has conducted an initial internal review of efficacy, safety and pharmacokinetic data from a subset of patients from Part 1 of IMerge(TM) and this review indicated that emerging safety and efficacy in IMerge(TM) is consistent with data reported from the pilot study conducted at Mayo Clinic in MDS patients. IMerge(TM) will continue unmodified at this time.

    Further assessment of data from IMerge(TM) is expected to occur in the second quarter of 2017 to include longer follow-up of all patients enrolled in Part 1. A decision on whether to move forward to Part 2 of IMerge(TM) will be based on an assessment of the benefit/risk profile of imetelstat in these patients. If Janssen decides to move forward with Part 2, the Phase 3 clinical trial is expected to be open for patient enrollment in mid-2017.

    Janssen expects to submit data from Part 1 of IMerge(TM) to be considered for presentation at a medical conference in the future.

    Conference Call

    At 8:00 a.m. EDT on September 12, 2016, Geron's management will host a conference call to review outcomes from the internal data reviews of IMbark(TM) and IMerge(TM) . Participants can access the conference call live via telephone by dialing 877-303-9139 (U.S.); 760-536-5195 (international). The passcode is 80522983. A live audio-only webcast is also available on the company's website at www.geron.com under Events and at edge.media-server.com. The audio webcast of the conference call will be available for replay approximately one hour following the live broadcast through October 13, 2016.

    About Imetelstat

    Imetelstat (GRN163L; JNJ-63935937) is a potent and specific inhibitor of telomerase that is administered by intravenous infusion. This first-in-class compound, discovered by Geron, is a specially designed and modified short oligonucleotide, which targets and binds directly with high affinity to the active site of telomerase. Preliminary clinical data suggest imetelstat has disease-modifying activity by inhibiting the progenitor cells of the malignant clones associated with hematologic malignancies in a relatively select manner. Most commonly reported adverse events in imetelstat clinical studies include fatigue, gastrointestinal symptoms and cytopenias. Patients in these studies also experienced elevated liver enzymes, which resolved to normal or baseline in the majority of patients followed after imetelstat treatment was withdrawn. Imetelstat has not been approved for marketing by any regulatory authority.

    About the Collaboration with Janssen

    On November 13, 2014, Geron entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc., to develop and commercialize imetelstat for oncology, including hematologic myeloid malignancies, and all other human therapeutics uses. Under the terms of the agreement, Geron received an upfront payment of $35 million and is eligible to receive additional payments up to a potential total of $900 million for the achievement of development, regulatory and commercial milestones, as well as royalties on worldwide net sales. All regulatory, development, manufacturing and promotional activities related to imetelstat are being managed through a joint governance structure, with Janssen responsible for these activities.

    About Geron

    Geron is a clinical stage biopharmaceutical company focused on the collaborative development of a first-in-class telomerase inhibitor, imetelstat, in hematologic myeloid malignancies. For more information about Geron, visit www.geron.com.

    Use of Forward-Looking Statements

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    From: hollyhunter10/3/2016 9:33:16 AM
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    Indicators show bullish cross in MACD and Stochastic oscillator.

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    From: Savant11/7/2016 10:10:27 AM
       of 3523
     
    Geron Announces November Investor Conference Presentation Webcasts

    MENLO PARK, Calif., Nov. 07, 2016 (GLOBE NEWSWIRE) -- Geron Corporation (Nasdaq:GERN) today announced that John A. Scarlett, M.D., President and Chief Executive Officer, is scheduled to present at the following investor conferences:

    -- Stifel 2016 Healthcare Conference in New York at 9:30 a.m. ET on Tuesday, November 15, 2016. -- Piper Jaffray 28th Annual Healthcare Conference in New York at 12:30 p.m. ET on Wednesday, November 30, 2016. A live audio webcast of each presentation will be available through the Homepage and Investor Relations section of Geron's website under Events. Following the live presentations, the webcasts will be archived and available for replay for a period of 30 days.

    About Geron

    Geron is a clinical stage biopharmaceutical company focused on the collaborative development of a first-in-class telomerase inhibitor, imetelstat, in hematologic myeloid malignancies. For more information about Geron, visit www.geron.com.

    CONTACT: Anna Krassowska, Ph.D. Investor and Media Relations 650-473-7765 investor@geron.com media@geron.com

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    From: Savant12/7/2016 10:07:47 AM
       of 3523
     
    Geron Reports Imetelstat Presentations at American Society of Hematology Annual Meeting

    MENLO PARK, Calif., Dec. 06, 2016 (GLOBE NEWSWIRE) -- Geron Corporation (Nasdaq:GERN) today announced four presentations of exploratory preclinical and clinical data related to the imetelstat program at the 58th American Society of Hematology (ASH) Annual Meeting and Exposition held in San Diego, California from December 3-6, 2016. The presentations are available on Geron's website at www.geron.com/presentations.

    "The imetelstat data presented at ASH this year indicate the potential application of imetelstat in multiple myeloid malignancies," said John A. Scarlett, M.D., Geron's President and Chief Executive Officer. "These presentations reflect the ongoing work by academic scientists, clinical investigators and our colleagues at Janssen to advance the imetelstat program, and support the clinical trials being conducted by Janssen in patients with myelofibrosis and myelodysplastic syndromes, who are in need of new treatment options."

    Oral Presentation

    Title: The preclinical efficacy of a novel telomerase inhibitor, imetelstat, in AML - a randomized trial in patient-derived xenografts (Abstract #578)

    Academic scientists presented data of imetelstat's activity in human acute myeloid leukemia (AML) xenograft models. The preclinical data demonstrated that imetelstat prolonged overall survival of AML xenografts derived from nine out of 15 individual patient samples compared to saline-treated controls, with robust responses associated with favorable cytogenetic risk groups and mutations in molecular pathways controlling DNA damage. The effects on normal human hematopoiesis were modest and predominantly seen in the B-lymphocyte lineage with relative preservation of myeloid and stem cell populations. These data build on previously published preclinical work conducted in patient-derived models of AML and suggest potential application of imetelstat in the treatment of AML.

    Poster Presentations

    Title: Characterization of Disease, Treatment Patterns, and Outcomes of Patients with Myelofibrosis: Analysis of 2 United States Commercial Claims Databases (Abstract #4769)

    Janssen presented an analysis of treatment patterns and outcomes of patients with myelofibrosis (MF) diagnosed between 2006 and 2015 from two United States medical health insurance claims databases. The analysis suggests that many MF patients (43%) received no treatment or supportive care, and only a fraction received ruxolitinib in spite of a favorable median overall survival associated with frontline treatment (30 months compared with 22 months for patients receiving other treatments). Among patients who failed or discontinued frontline ruxolitinib, the median overall survival was seven months, which underscores the need for new treatment options for this disease.

    Title: Dynamics of Telomere Length Reflect the Clonal Suppression Seen with the Telomerase Inhibitor Imetelstat in Patients with Essential Thrombocythemia (Abstract #1938)

    Academic scientists and clinical investigators from the prior Geron-sponsored proof-of-concept study in patients with essential thrombocythemia (ET) presented new clinical data on telomere length dynamics following treatment with imetelstat. The data showed that in 10 out of 13 ET patients, telomere length in granulocytes was higher after nine months of treatment with imetelstat, and the change correlated with the reduction of JAK2V617F mutational burden. These observations suggest that imetelstat may suppress neoplastic clones and favor recovery of normal hematopoiesis in these patients providing further evidence of the potential disease-modifying activity of imetelstat in hematologic myeloid malignancies.

    Title: Telomerase Inhibition with Imetelstat Eradicates -catenin Activated Blast Crisis Chronic Myeloid Leukemia Stem Cells (Abstract #3065)

    Academic scientists presented a preliminary investigation into the potential impact of imetelstat on leukemia stem cells in non-clinical models of chronic myeloid leukemia (CML) in blast crisis. The preclinical data suggest that imetelstat plus dasatinib, a standard treatment for CML, may inhibit self-renewal of blast crisis cells in vitro compared with normal bone marrow progenitors. In mouse xenograft models of blast crisis CML, imetelstat treatment reduced the number of leukemia progenitor cells detected in bone marrow and decreased expression of -catenin, which is believed to be required for the self-renewal of leukemic stem cells in CML. This is the first report of data to suggest that imetelstat might inhibit proliferation of malignant progenitors in CML.

    About Imetelstat

    Imetelstat (GRN163L; JNJ-63935937) is a potent and specific inhibitor of telomerase that is administered by intravenous infusion. This first-in-class compound, discovered by Geron, is a specially designed and modified short oligonucleotide, which targets and binds directly with high affinity to the active site of telomerase. Preliminary clinical data suggest imetelstat has disease-modifying activity by inhibiting malignant progenitor cell clones associated with hematologic malignancies in a relatively select manner. Most commonly reported adverse events in imetelstat clinical studies include fatigue, gastrointestinal symptoms and cytopenias. Patients in these studies also experienced elevated liver enzymes, which resolved to normal or baseline in the majority of patients followed after imetelstat treatment was withdrawn. Imetelstat has not been approved for marketing by any regulatory authority.

    About the Collaboration with Janssen

    On November 13, 2014, Geron entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc., to develop and commercialize imetelstat for oncology, including hematologic myeloid malignancies, and all other human therapeutics uses. Under the terms of the agreement, Geron received an upfront payment of $35 million and is eligible to receive additional payments up to a potential total of $900 million for the achievement of development, regulatory and commercial milestones, as well as royalties on worldwide net sales. All regulatory, development, manufacturing and promotional activities related to imetelstat are being managed through a joint governance structure, with Janssen responsible for these activities.

    About Geron

    Geron is a clinical stage biopharmaceutical company focused on the collaborative development of a first-in-class telomerase inhibitor, imetelstat, in hematologic myeloid malignancies. For more information about Geron, visit www.geron.com.

    Use of Forward-Looking Statements

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    From: tktrimbath12/31/2016 9:06:11 PM
       of 3523
     
    My end of year review of GERN

    INTRO Here's my semi-annual exercise to see if I remember why I own the stocks I own, and so I can check back and see if their stories have changed. I post in case it helps others too.

    Geron
    GERN (market cap was $0.426B mid2016 is $0.329B EOY2016)
    Geron is developing leading edge biotechnologies based on telomerase, a protein that helps control cell death. The drug is in clinical trials for treating "hematologic myeloid malignancies", which I translate as blood disorders. The potential is very large because controlling cell death has the potential to encourage cells to die on demand, thereby treating cancers; or convincing them not to destroy themselves, which can be an issue in auto-immune disorders.

    They are in phase 2 clinical trials, but the data have underwhelmed the investment community.

    At one time, the company had four major technologies in development. Now, they are down to one major technology. Diversification within a company is not a guarantee. The clinical trials continue, but I must admit that their past performance is affecting my expectations of their future performance. I am considering selling GERN to buy AST, which happens to be advancing one of Geron's other spun-off technologies.

    DISCLOSURE LTBH since 1999 and continuing to hold (though I sold much, partly for diversification, partly to raise funds.)
    (I've also collected links to the other discussion boards and my other stocks over on my blog trimbathcreative.wordpress.com

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