Shares of Gilead Sciences�(GILD) fell 3.6% today, and the experts I spoke with said that they didn’t see a catalyst for the drop, one that dragged the entire biotech sector down with it.
Now there are two possibilities. StreetInsider.com and the Fly On the Wall both referred to a voluntary recall of Gilead’s HIV-drug Atripla, though both made referencer to a Deutsche Bank report that dismissed the recall as minor and unlikely to have a major impact.
But there’s another possibility. Citigroup’s Yaron Weber explains:
Today, at the CROI meeting, data from the NEAT 001/ANRS143 trial testing the combination of Isentress + Prezista/ritonavir (ie nuc sparing) in 805 new HIV patients showed non-inferiority to Prezista/ritonavir + Gilead’s Truvada.
It looks to us that there is finally some legitimate competitor to Gilead�� HIV regimens that could be cheaper and viable for 85% of patients. However, the Isentress/Prezista regimen will require more pills/day and will have more side effects. At this point, a formal development plan will need to be undertaken by either Merck or JNJ or both to support registration of this regimen. As the standard of care is shifting, they might also need to test the regimen against Gilead�� Stribild. As such, we do not anticipate that this regimen will be licensed until at least another 2-3 years.�
Best Airline Stocks To Own For 2015: Taro Pharmaceutical Industries Ltd (TARO)
Taro Pharmaceutical Industries Ltd., incorporated in 1959, is a science-based pharmaceutical company. The Company develops manufactures, and markets prescription and over-the-counter (OTC) pharmaceutical products, primarily in the United States, Canada and Israel. The Company also develops and manufactures active pharmaceutical ingredients (APIs), primarily for use in its finished dosage form products. The Company�� primary areas of focus include pediatric creams and ointments, liquids, capsules and tablets, mainly in the dermatological and topical, cardiovascular, neuropsychiatric and anti-inflammatory therapeutic categories. The Company operates through three companies: Taro Pharmaceutical Industries Ltd. (Taro Israel), and two of its subsidiaries (including indirect), Taro Pharmaceuticals Inc. (Taro Canada) and Taro U.S.A. The Company markets more than 180 pharmaceutical products in over 25 countries.
Taro Israel manufactures more than 160 finished dosage form pharmaceutical products for sale in Israel and for export. It produces APIs used in the manufacture of finished dosage form pharmaceutical products. It markets and distributes generic products in the local Israeli market. Taro Israel�� primary product lines include dermatology, prescription and OTC semi-solid products (creams, ointments and gels) and liquids; cardiology and neurology, prescription oral dosage products; oral analgesics, both prescription and OTC, and OTC oral and nasal sprays and ophthalmic products.
Taro Canada manufactures more than 70 finished dosage form pharmaceutical products for sale in Canada and for export. It markets and distributes generic products in the local Canadian market. Its product line includes dermatology: prescription and OTC semi-solid products (creams, ointments and gels) and liquids, cardiology, oncology, gastrointestinal and neurology: prescription oral and injects able dosage products, and allergy (antihistamine): OTC oral dosage products.
Taro U.S.A markets! and distributes generic products in the United States market. Its primary product lines include dermatology: prescription and OTC semi-solid products (creams, ointments and gels) and liquids, cardiology and neurology: prescription oral dosage products, and other prescription and OTC products.
The Company competes with Bristol-Myers Squibb, GlaxoSmithKline, Merck, Novartis, Pfizer/Wyeth, Valeant, Galderma, Merck/Schering-Plough, Teva Pharmaceuticals U.S.A., Mylan Laboratories, Perrigo Company, Ranbaxy Pharmaceuticals Inc., Sandoz Pharmaceuticals, Merck Canada Inc., Pfizer Canada Inc., Janssen Inc., Schering-Plough Canada, Novartis Pharmaceuticals Canada Inc., GlaxoSmithKline Inc., Bayer Inc., Bristol-Myers Squibb Canada, Apotex Inc., Teva Canada Limited, Mylan Pharmaceuticals ULC, Sandoz Canada Incorporated, Pharmascience Inc., Teva Pharmaceutical Industries Ltd., Perrigo Israel Pharmaceuticals Ltd., Dexxon Ltd., Rafa Laboratories Ltd., Bayer AG, Eli Lilly and Company, Merck & Co., Inc. and Pfizer Inc.
Advisors' Opinion:- [By Rich Smith]
Israeli drugmaker Taro Pharmaceutical Industries (NYSE: TARO ) has a new CEO -- and a new Chairman of the Board, as well.
On Thursday, Taro announced the imminent retirement of Interim Chief Executive Officer Mr. James Kedrowsk, who will be replaced August 1 by new permanent CEO Mr. Kalyanasundaram Subramanian ("Kal Sundaram"). Additionally, the company said that Dilip Shanghvi�has been appointed Chairman of its Board of Directors.
Hot Biotech Stocks To Buy For 2014: Portola Pharmaceuticals Inc (PTLA)
Portola Pharmaceuticals, Inc. (Portola), incorporated on September 2, 2003, is a biopharmaceutical company developing product candidates that have the potential to represent advances in the fields of thrombosis and hematology. The Company is advancing its three wholly owned programs using biomarker and genetic approaches.
Betrixaban
Portola's compound, betrixaban, is an oral, once-daily Factor Xa inhibitor being evaluated in the only biomarker-based Phase-III study for hospital to home prophylaxis of venous thromboembolism (VTE) in acute medically ill patients. Betrixaban's properties particularly suited to potentially demonstrate efficacy without increasing bleeding in this patient population.
Andexanet Alfa
Portola's second development candidate, andexanet alfa (PRT4445), has the potential to be a reversal agent to directly reverse the effects of Factor Xa inhibitors in patients who suffer a bleeding episode or who require emergency surgery. Portola has entered into clinical collaboration agreements with all of the manufacturers of direct Factor Xa inhibitors, including Bristol-Myers Squibb and Pfizer (Eliquis [apixaban]), Bayer HealthCare and Janssen Pharmaceuticals (XARELTO [rivaroxaban]), and Daiichi Sankyo (Savaysa [edoxaban]), while retaining all decision-making and commercial rights to the program.
Cerdulatinib (PRT2070) and PRT2607
Portola's third wholly owned product candidate, cerdulatinib (PRT2070), is an orally available kinase inhibitor that uniquely inhibits two validated tumor proliferation pathways - spleen tyrosine kinase (Syk) and janus kinase (JAK). It is being studied in patients with leukemias or lymphomas with a focus on genetically-defined subtypes, as well as in patients who have failed therapy due to relapse or acquired mutations. Portola's fourth program is partnered with Biogen Idec and is focused on the development of PRT2607, a selective Syk inhibitor.
Advisors' Opinion:- [By Todd Campbell]
That leads me to Medivation (NASDAQ: MDVN ) , Ophthotech (NASDAQ: OPHT ) , and Portola (NASDAQ: PTLA ) , three companies with important therapies that may very well be destined to become top sellers.
Hot Biotech Stocks To Buy For 2014: Cellular Dynamics International Inc (ICEL)
Cellular Dynamics International, Inc., incorporated on November 16, 2007, develops and manufactures fully functioning human cells in industrial quantities to precise specifications. The Company�� iCell Operating System (iCell O/S) includes true human cells in multiple cell types (iCell products), human induced pluripotent stem cells (iPSCs) and custom iPSCs and iCell products (MyCell products). Customers use its iCell O/S products, among other purposes, for drug discovery and screening; to test the safety and efficacy of their small molecule and biologic drug candidates; for stem cell banking; and in researching cellular therapeutics. The Company�� iCell product line includes four different cell types: cardiomyocytes, neurons, hepatocytes and endothelial cells. The Company is actively developing an additional seven different cell types. iCell products are a consumable designed to be used once and then reordered.
The Company manufactures its iCell products from its iPSCs. An iPSC is a cell that has the ability both to replicate indefinitely and to be transformed into any cell type in the human body. The Company�� iCell O/S consists of six products, which include iCell Cardiomyocytes, iCell Neurons, iCell Endothelial Cells, iCell Hepatocytes and MyCell.
Advisors' Opinion:- [By John Udovich]
Stem cells may not be in the news much�as the sector has moved beyond the use of embryotic�ones, but small cap stem cell stocks Cellular Dynamics International Inc (NASDAQ: ICEL), International Stem Cell Corp (OTCMKTS: ISCO) and BioRestorative Therapies (OTCBB: BRTX) have been fairly active over the past several trading days as ICEL went public, ISCO raised additional funding and BRTX grabbed more attention:
Hot Biotech Stocks To Buy For 2014: Horizon Pharma Inc (HZNP)
Horizon Pharma, Inc. (Horizon), incorporated on March 23, 2010, is a biopharmaceutical company that develops and commercializes medicines to target unmet therapeutic needs in arthritis, pain and inflammatory diseases. On April 23, 2011, the United States Food and Drug Administration, approved DUEXIS (formerly HZT-501), a tablet formulation containing a fixed-dose combination of ibuprofen and famotidine in a single pill. The Company�� other product, LODOTRA (NP-01), is a programmed release formulation of low-dose prednisone that is marketed in Europe by the Company�� distribution partner, Mundipharma International Corporation Limited (Mundipharma). As of December 31, 2010, Horizon completed multiple Phase III clinical trials of LODOTRA. In addition to these product candidates, the Company has a pipeline of earlier-stage product candidates to treat pain-related diseases and chronic inflammation. On April 1, 2010, Horizon effected a recapitalization and acquisition pursuant to which Horizon Pharma, Inc. became a holding company, that operates through its wholly owned subsidiaries, Horizon Pharma USA, Inc. (formerly Horizon Therapeutics, Inc.) and Horizon Pharma AG (formerly Nitec Pharma AG (Nitec)).
DUEXIS
DUEXIS is a combination of 800 milligram ibuprofen and 26.6 milligram famotidine in a single pill and is indicated for the relief of signs and symptoms of rheumatoid arthritis (RA), and osteoarthritis (OA), and to decrease the risk of developing upper gastrointestinal (GI), ulcers in patients who are taking ibuprofen for those indications. The Company has completed two Phase III clinical trials in a total of over 1,500 patients with mild to moderate pain or arthritis that demonstrated a significant reduction in the incidence of non-steroidal anti-inflammatory drugs (NSAID)-induced upper GI ulcers when treated with DUEXIS versus ibuprofen alone.
LODOTRA
LODOTRA is a programmed release formulation of low-dose prednisone, a well-established drug use! d to inhibit the production of various pro-inflammatory cytokines, which are proteins associated with joint inflammation in RA. LODOTRA has received regulatory approval in Europe for the treatment of moderate to severe, active RA in adults when accompanied by morning stiffness. As of December 31, 2010, the Company had completed two pivotal Phase III clinical trials of LODOTRA in a total of over 600 patients with RA. The first pivotal Phase III trial supported the approval of LODOTRA in Europe in March 2009, where it is approved for marketing in 14 European countries. LODOTRA achieved significant results and met the primary endpoint in each of the two pivotal Phase III clinical trials. Its LODOTRA product was developed and is owned by Horizon Pharma AG. As of December 31, 2010, the Company markets LODOTRA in Europe through three separate agreements. Pursuant to two separate agreements, it granted Merck Serono GmbH and Merck GesmbH, an affiliate of Merck Serono, the rights to distribute and market LODOTRA in each of Germany and Austria, respectively, and pursuant to the third agreement, it granted Mundipharma rights to distribute and market LODOTRA in the rest of Europe. The Company also has a manufacturing and supply agreement with Jagotec AG under which Jagotec or its affiliates manufacture and supply LODOTRA to the Company as bulk tablets.
The Company competes with Pfizer Inc., Pozen Inc., Abbott Laboratories and Amgen Inc.
Advisors' Opinion:- [By Bryan Murphy]
After a 16% rally on Tuesday, it would be understandable is a newcomer wanted to steer clear of Horizon Pharma Inc. (NASDAQ:HZNP). After all, how much more upside can there be for this fairly typical small cap biotech stock. Yet, HZNP may well be one of the rare exceptions to the "tough to follow-through" tendency.
For those not familiar, HZNP is a biopharma name with a couple of rheumatoid arthritis, COPD, and asthma drugs on the market... Duexis, and Rayos. There's a third drug in the pipeline - Lodotra, for polymyalgia rheumatica, though it's already approved as a treatment for RA.� Either way, Horizon Pharma Inc. is unique in the sense that though it's a small biopharma company, it's at least driving revenue with a handful of marketable products.
The pipeline and portfolio are secondary at this point, however. What matters most to traders now is whether or not there's actually any upside left to tap into with Horizon Pharma. The answer is, it depends.
Given just the nearby daily chart, no, it looks like HZNP has burned up all of its fuel. Aside from the fact that it's overextended now, Tuesday's volume spike also implies anybody who was thinking about buying went ahead and took the plunge. That may well mean nobody is left to keep buying tomorrow. There may well be, however, plenty of nervous-Nellie profit-takers ready to head for the exit.
The assessment changes quite a bit when you zoom out to a longer-term chart of Horizon Pharma, though.
While this won't allow the stock to sidestep a near-term pullback, Tuesday's pop was something a game-changer for the long-term chart. The move shook the stock out of a narrow range that had trapped the stock between $2.80 and $2.12 for the last ten months.
The proverbial "so what" is, with nearly a years' worth of pent-up energy finally being unleashed, we're nowhere near the end of the final resting place. Once we burn off this initial, knee-jerk reaction to the - [By Lisa Levin]
Horizon Pharma (NASDAQ: HZNP) shares reached a new 52-week high of $17.12 after the company announced its plans to acquire privately held Vidara Therapeutics International for around $660 million.
- [By Jake L'Ecuyer]
Leading and Lagging Sectors
Wednesday morning, the healthcare sector proved to be a source of strength for the market. Leading the sector was strength from Horizon Pharma (NASDAQ: HZNP) and Pernix Therapeutics Holdings (NASDAQ: PTX). In trading on Wednesday, telecommunications services shares were relative laggards, down on the day by about 0.39 percent. Top decliners in the sector included Shenandoah Telecommunications Co (NASDAQ: SHEN), off 3.3 percent, and CalAmp (NASDAQ: CAMP), down around 2.4 percent.
Hot Biotech Stocks To Buy For 2014: Hemispherx Biopharma Inc (HEB)
Hemispherx Biopharma, Inc. (Hemispherx) is a specialty pharmaceutical company engaged in the clinical development of new drugs therapies based on natural immune system enhancing technologies for the treatment of viral and immune based chronic disorders. Hemispherx focuses on two core pharmaceutical technology platforms Ampligen and Alferon N Injection.The commercial focus for Ampligen includes application as a treatment for Chronic Fatigue Syndrome (CFS) and as an influenza vaccine enhancer (adjuvant) for both therapeutic and preventative vaccine development. Alferon N Injection is a United States Food and Drug Administration (FDA) approved product with an indication for refractory or recurring genital warts. Alferon LDO (Low Dose Oral) is a formulation under development targeting influenza. It has three subsidiaries BioPro Corp., BioAegean Corp., and Core BioTech Corp. The Company's foreign subsidiary is Hemispherx Biopharma Europe N.V./S.A.
Ampligen
Ampligen is an experimental drug, which is undergoing clinical development for the treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). Over 1,000 patients have participated in the Ampligen clinical trials representing the administration of more than 90,000 doses of this drug. The Company is also engaged in ongoing, experimental studies assessing the efficacy of Ampligen against influenza viruses.
Alferon N Injection
Alferon N Injection is the registered trademark for the Company's injectable formulation of natural alpha interferon. Interferons are a group of proteins produced and secreted by cells to combat diseases. The Company's natural alpha interferon is produced from human white blood cells. Alferon N Injection [Interferon alfa-n3 (human leukocyte derived)] is a highly purified, natural-source, glycosylated, multi-species alpha interferon product.
Alferon LDO (Low Dose Oral)
Alferon LDO [Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived)]! is an experimental low-dose, oral liquid formulation of Natural Alpha Interferon and like Alferon N Injection should not cause antibody formation, which is a problem with recombinant interferon. It is an experimental immunotherapeutic that works by stimulating an immune cascade response in the cells of the mouth and throat, enabling it to bolster systemic immune response through the entire body by absorption through the oral mucosa.
The Company competes with Pfizer, GlaxoSmithKline, Merck, AstraZeneca, Baxter International, Fletcher/CSI, AVANT Immunotherapeutics, AVI BioPharma and Genta.
Advisors' Opinion:- [By MONEYMORNING]
Hemispherix Biopharma Inc. (NYSE: HEB) is a specialty pharmaceutical company. It engages in the clinical development of new drug therapies based on natural immune system enhancing technologies and targets the treatment of viral and immune-based clinical disorders. The Philadelphia, Pa.-headquartered company gained widespread attention over the last several months for its work on flu research. Its flagship products include Alferon N Injection, approved by the FDA for a category of sexually transmitted disease infection. Experimental treatments include Ampligen and Oragens, in development stages for the potential treatment of global viral diseases and disorders of the immune system including human papilloma virus, human immunodeficiency virus, chronic fatigue syndrome, hepatitis, and influenza. Shares have traded as low as $0.18 and as high as $0.55 over the last year. At last check, shares were changing hands around $0.50 on volume of 2 million shares.
Hot Biotech Stocks To Buy For 2014: Protalix Biotherapeutics Inc (PLX)
Protalix BioTherapeutics, Inc. is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins based on its ProCellEx protein expression system, ProCellEx. Using its ProCellEx system, the Company is developing a pipeline of biosimilar or generic versions of recombinant therapeutic proteins based on its plant cell-based expression technology, which focuses pharmaceutical markets and that rely upon known biological mechanisms of action. ProCellEx protein expression system consists of a set of technologies and capabilities for the development of recombinant proteins, including advanced genetic engineering technology and plant cell-based protein expression methods. Its ProCellEx protein expression system is built on flexible custom-designed bioreactors made of polyethylene and optimized for the development of complex proteins in plant cell cultures. In June 2010, it had completed the preliminary phase I clinical trial of PRX-105.
Taliglucerase Alfa
Taliglucerase alfa is a plant cell expressed recombinant glucocerebrosidase enzyme (GCD) for the treatment of Gaucher disease. The Company has commenced pre-clinical studies of an oral form of taliglucerase alfa. Its oral taliglucerase alfa is a plant cell expressed form of GCD that is naturally encapsulated within carrot cells genetically engineered to express the GCD enzyme. Pre-clinical studies of oral taliglucerase alfa demonstrate the stability of the enzyme in the cell and the capacity of the cell�� cellulose wall to protect the enzyme against degradation in the digestive tract in an in-vitro model of the stomach and intestines. Additionally, rats fed with lyophilized carrot cells expressing GCD have accumulated the active enzyme in the target organs; the spleen and liver. As of December 31, 2010, the Company had completed Phase III Clinical Trial.
PRX-102
The Company is developing PRX-102, its plant cell expressed modified version of the recombinant ! alpha-GAL-A protein, a therapeutic enzyme for the treatment of Fabry disease. Fabry disease is a rare, hereditary, genetic lysosomal storage disorder in humans caused by an X-lined deficiency of the alpha-GAL-A enzyme. The Company is in the animal evaluation testing phase of the development of PRX-102, which tests are based on a mouse model for Fabry disease.
Acetylcholinesterase
Protalix Ltd. is a wholly owned subsidiary of the Company is licensed the rights to certain technology under a research and license agreement with Yissum Research and Development Company (Yissum) and the Boyce Thompson Institute, Inc. Pursuant to the agreement, the Company is developing PRX-105, a plant cell-based acetylcholinesterase (AChE) and its molecular variants for the use in several therapeutic and prophylactic indications, as well as in a biodefense program and an organophosphate-based pesticide treatment program.
As of December 31, 2010, its in-vitro experiments of PRX-105 have shown that the acetylcholinesterase enzyme in its ProCellEx protein expression system demonstrates biological activity on biochemical and cellular levels. In addition, early animal studies demonstrated that the acetylcholinesterase expressed in its ProCellEx protein expression system was able to treat animals exposed to the nerve gas agent analogues, both when injected with its acetylcholinesterase product candidate immediately before exposure or when injected after exposure. In March 2010, it initiated a preliminary phase I clinical trial of PRX-105, which the Company completed in June 2010.
pr-antiTNF
pr-antiTNF is a candidate for the treatment of certain autoimmune diseases such as rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing, spondylitis, psoriatic arthritis and plaque psoriasis. The Company has designed the antiTNF as pr-antiTNF. pr-antiTNF is a plant cell-expressed recombinant fusion protein made from the soluble form of the human TNF receptor (TNFR), f! used to t! he Fc component of a human antibody domain. pr-antiTNF has an identical amino acid sequence to Enbrel and its in-vitro and preclinical animal studies have demonstrated that pr-antiTNF exhibits similar activity to Enbrel. Specifically, pr-antiTNF binds TNF thereby inhibiting it from binding to cellular surface TNF receptors and protects L929 cells from TNF-induced apoptosis in a dose-dependent manner.
The Company competes with Genzyme, Actelion, Crucell N.V., Biolex, Inc., Chlorogen, Inc., Greenovation Biotech GmbH, Symbiosys, Novartis AG/Sandoz Pharmaceuticals, BioGeneriX AG, Stada Arzneimittel AG, BioPartners GmbH and Teva.
Advisors' Opinion:- [By Keith Speights]
Other investors might wish that Pfizer would use some of its cash to acquire a few smaller companies. Protalix BioTherapeutics (NYSEMKT: PLX ) has been mentioned as one possible candidate. The two companies already partner together on Gaucher disease drug Elelyso. In February, Protalix spurred rumors that Pfizer could be interested in buying the company after it announced that it had engaged Citigroup to pursue a "broad array of strategic alternatives."
- [By Maxx Chatsko]
Industrial biotech isn't the only industry headed to Brazil. Protalix (NYSEMKT: PLX ) entered into a technology transfer agreement with Brazil's Ministry of Health last week that will pay the company $280 million. The deal is big news for Protalix's first product, Elelyso/Uplyso, which was developed with partner Pfizer (NYSE: PFE ) . The treatment is approved as an enzyme replacement therapy, or ERT, for adults with type 1 Gaucher disease, and it marks a huge step forward for the future of biomanufacturing. In the following video, Fool contributor Maxx Chatsko explains what this means for the product's commercialization and the adoption of Protalix's novel plant cell-based expression system for therapeutic proteins.
Hot Biotech Stocks To Buy For 2014: ArQule Inc.(ARQL)
ArQule, Inc., a clinical-stage biotechnology company, engages in the research and development of cancer therapeutics directed toward molecular targets and biological processes. Its lead product ARQ 197 is non-adenosine triphosphate competitive inhibitor of the c-Met receptor tyrosine kinase, which is being evaluated as monotherapy and in combination therapy in a Phase II clinical development program that includes trials in non-small cell lung cancer, c-Met-associated soft tissue sarcomas, pancreatic adenocarcinoma, hepatocellular carcinoma, germ cell tumors, and colorectal cancer. The company is also developing ARQ 621, a Phase I program focused on inhibition of the Eg5 kinesin spindle protein. Its clinical stage products include ARQ 501, ARQ 761, and ARQ 171, which are designed to kill cancer cells selectively while sparing normal cells through the direct activation of DNA damage response/checkpoint pathways. In addition, the company involves in pre-clinical development o f B-RAF and AKIP Kinase inhibitors. The company has collaborations with Kyowa Hakko Kirin Co., Ltd. and Daiichi Sankyo Co., Ltd. ArQule, Inc. was founded in 1993 and is headquartered in Woburn, Massachusetts.
Advisors' Opinion:- [By Roberto Pedone]
ArQule (ARQL), a clinical-stage biotechnology company, researches and develops cancer therapeutics. This stock closed up 3.4% to $1.49 in Thursday's trading session.
Thursday's Range: $1.44-$1.54
52-Week Range: $1.29-$2.94
Thursday's Volume: 908,000
Three-Month Average Volume: 567,811From a technical perspective, ARQL jumped higher here right above some near-term support at $1.40 with above-average volume. This move briefly pushed shares of ARQL back above its 50-day moving average of $1.53, before the stock closed just below that level at $1.49. This move is starting to push shares of ARQL within range of triggering a near-term breakout trade. That trade will hit if ARQL manages to take out some near-term overhead resistance levels at $1.54 to $1.60 with high volume.
Traders should now look for long-biased trades in ARQL as long as it's trending above some near-term support levels at $1.40 or at $1.35 and then once it sustains a move or close above those breakout levels with volume that hits near or above 567,811 shares. If that breakout hits soon, then ARQL will set up to re-test or possibly take out its next major overhead resistance levels at $1.66 to $1.78, or even $1.90 to $2.
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