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Roche Enters Noninvasive Prenatal Test Market With Ariosa Purchase

December 2, 2014 – 12:13 pm | Edit Post

Eyeing the biotech IPO boom earlier this year, Ariosa Diagnostics planned to go public as it battled larger competitors in the prenatal testing field. But the San Jose, CA-based company backed off in…

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Roche Enters Noninvasive Prenatal Test Market With Ariosa Purchase

December 2, 2014 – 12:13 pm | Edit Post

Eyeing the biotech IPO boom earlier this year, Ariosa Diagnostics planned to go public as it battled larger competitors in the prenatal testing field. But the San Jose, CA-based company backed off in…

[[Click headline to continue reading.]]

Roche Enters Noninvasive Prenatal Test Market With Ariosa Purchase

December 2, 2014 – 12:13 pm | Edit Post

Eyeing the biotech IPO boom earlier this year, Ariosa Diagnostics planned to go public as it battled larger competitors in the prenatal testing field. But the San Jose, CA-based company backed off in…

[[Click headline to continue reading.]]

Roche Enters Noninvasive Prenatal Test Market With Ariosa Purchase

December 2, 2014 – 12:13 pm | Edit Post

[Ben Fidler contributed to this report.] Eyeing the biotech IPO boom earlier this year, Ariosa Diagnostics planned to go public as it battled larger competitors in the prenatal testing field. But the…

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Teikoku Pharma USA Announces Positive Study Results of 7-Day Patch for Parkinson’s Disease

December 2, 2014 – 8:30 am | Edit Post

SAN JOSE, Calif., Dec. 2, 2014 /PRNewswire/ – Teikoku Pharma USA announced positive results of a recently completed bioavailability (BA) study examining the delivery of TPU-002RA, a 7-day rasagiline patch, for Parkinson’s disease. This study was part of the U.S. Food and Drug Administration (FDA) recommended program for a 505(b)(2) New Drug Application (NDA) for TPU-002RA and will be a critical component of this product’s NDA.

The study confirmed that one patch of rasagiline applied for 7 days achieved a higher systemic exposure than that of AZILECT® (rasagiline) 1mg tablets administered orally once daily for 7 days. Additionally, the patch produced more consistent blood levels of rasagiline throughout the 7 day period, without any significant peaks as seen with the oral product.

Paul Mori, Executive Vice President and COO said, “We are pleased to have demonstrated the ability of our unique transdermal drug delivery technology to provide systemic drug exposure equivalent or greater than the oral product at its therapeutically effective dose. The patch offers the potential for improved medication adherence and reduction of caregiver workload.” He continued, “The outcome of this study not only satisfies the FDA’s request, but also enhances the probability of success for a patient-friendly rasagiline product.”

About the Parkinson’s Disease Market

Parkinson’s disease (PD) is the second most common neurodegenerative disease after Alzheimer’s disease. There are between 1 and 1.5 million Americans living with Parkinson’s disease.1 Worldwide patient population is estimated to 4 million and projected to grow to over 9 million cases.2,3 The main symptoms (stiffness, tremors, and slowed movements and gait) are caused by a loss of dopamine production by the neurons that are involved in controlling movement and coordination. 4,5 Overall, world revenue for drugs treating PD will reach $3,426M in 2016.5,6 There are 8 major anti-Parkinson drugs in U.S. market with MIRAPEX®, Carbidopa/levodopa, and REQUIP®. AZILECT® had 2013 sales of $240M in the US and $248M for Europe and Asia market, and is still enjoying sales growth of 19.4% growth in the US.7,8

Besides the foremost need to develop a therapy to slow Parkinson’s disease progression, several other important needs exist:

Alternative delivery systems to counter difficulty swallowing;
New less side-effect laden drugs for the delay of onset of dementia;
Cure that repairs and/or reverses the damage; and
Simplification of complex medical regimens.  About TPU-002RA

TPU-002RA is being developed for the treatment of Parkinson’s disease. This product uses Teikoku’s unique transdermal patch system and contains the same active drug component in AZILECT®, the only currently marketed form of rasagiline. Teikoku believes that our TPU-002RA offers potential advantages over AZILECT® oral and could seize a meaningful share of this rapidly growing market.

About Teikoku Pharma USA 

Teikoku Pharma USA Inc.(“TPU”), a wholly owned subsidiary of Teikoku Seiyaku Co., Ltd. of Japan, is an international specialty pharmaceutical company that develops and manufactures pharmaceutical products based on our delivery platform technologies. 

TPU is the NDA holder of LIDODERM® (Lidocaine 5% Patch) for post herpetic neuralgia (PHN), and Lidoderm is currently distributed by Endo Pharmaceuticals in the US, Grünenthal GmbH mainly in Europe, South America and Oceania, and other distributers in Asia.

Teikoku’s internal therapeutic focus is addressing unmet medical needs in the pain management, central nervous system, and oncology categories.

For more information please contact: Francisco Bejar at fbejar@teikokuusa.com

References:

Parkinson’s Foundation Website: Understanding Parkinson’s. PARKINSON Report, SPRING 2008:Available at: http://www.pdf.org/en/about_pdf_sub. Accessed: November 20, 2014.
Tanner CM, et al. Parkinson Disease: A Global View. Parkinson Report; Spring 2008: 9-11.
Kowal SL, et al. The Current and Projected Economic Burden of Parkinson’sDisease in the United States. Movement Disorders 2013; 28 (3): 311-18.
Rodriquez MC, et al. Initial clinical manifestations of Parkinson’s disease: featuresand pathophysiological mechanisms. Lancet Neurol 2009; 8: 1128–39.
Datamonitor Ref# DMKC0074741, Author: Daniel Chancellor, Publication date: December 4, 2013
ADR Reports, Parkinson’s Disease: World Drug Market 2014 – 2024.   Available at: https://www.asdreports.com/news.asp?pr_id=2322. Accessed: November 20, 2014.
IMS, NSP Ad-Hoc, Azilect 06/2006TVN, Accessed: November 20, 2014
Evaluate Ltd., Azilect Worldwide Sales Summary, Accessed: November 20, 2014 
SOURCE Teikoku Pharma USA

Catylix and Aspira Scientific Launch the First Reagent for Pentafluoroethylation

December 2, 2014 – 8:00 am | Edit Post

SAN FRANCISCO, Dec. 2, 2014 /PRNewswire/ — Catylix, Inc. (Burbank, California) and Aspira Scientific, Inc. (Milpitas, California) announced the launch of Pentafluoroethylator®, the first reagent for broad introduction of the pentafluoroethyl group. The reagent will be produced and distributed through a cooperation between Catylix and Aspira under sublicense from Catylix. The Pentafluoroethyl group has been advanced as the “New Substituent of the Future” for bioactive compound development by Catylix.

Pentafluoroethylator® reagent is available now in various gram quantities. Scaling to multi-kilograms and beyond is underway and expected to be commercial by the first quarter of 2015.

Based on the discoveries of Professor John Hartwig, now at the University of California Berkeley, Pentafluoroethylator® is a higher order analog of the previously launched Trifluoromethylator® and makes possible the rapid, one-step pentafluorethylation of aryl, heteroaryl, and vinyl iodides and bromides. The reagent is shelf stable, functions at or near ambient temperature, and has unprecedented functional group compatibility. Dr. David Rozzell, CEO of Catylix commented, “Pentafluoroethylator® is the fastest, easiest way to add a pentafluoroethyl group and evaluate the benefits of the New Substituent of the Future. Through our cooperation with Aspira, Pentafluoroethylator® will be available to chemists for the first time, enabling the one-step, facile introduction of the pentafluoroethyl group for evaluation in prospective drugs and crop protection agents.”

Pentafluoroethylation is a new chemical reaction for improving the effectiveness of bioactive compounds, particularly in the pharmaceutical and agricultural industries. Dr. John Chan, CEO of Aspira said, “We are excited to bring Aspira’s expertise in distribution and production to make this breakthrough pentafluoroethylation reagent available to both researchers and process chemists for the first time. As we bring down the cost, we anticipate wider application and increased demand.” More product information is available at: www.aspirasci.com/pentafluoroethylator.

About Aspira Scientific, Inc.

Aspira Scientific is a science-centric enterprise dedicated to empowering scientists reach their aspirations in chemical R&D. We achieve this goal through reducing the cost of basic and applied research by offering research products with superior value in terms of price and quality. By leveraging a truly global innovation ecosystem, we also make available a broader set of next-generation enabling tools for chemical synthesis. For organizations with developmental programs, we provide custom production services via “Collaborate Locally. Commercialize Globally.™” model to afford exceptional value in terms of innovation, quality and IP assurance, and cost-efficiency. For more information on realizing your scientific aspirations now and tomorrow, please visit www.aspirasci.com.

About Catylix, Inc.

Catylix, Inc. is an early-stage company specializing in the development and commercialization of new fluorination chemistry and novel products for the incorporation of fluorine-containing functionality. For more information about Catylix, please visit http://www.catylix.com.

MEDIA CONTACTJohn Chan, Ph.D.CEO, Aspira Scientificjohn.chan@aspirasci.comTel: 650-224-4037

David Rozzell, Ph.D.CEO, Catylix, Inc.david.rozzell@catylix.comTel: 818-388-6576

Logo – http://photos.prnewswire.com/prnh/20131205/AQ28432LOGO

SOURCE Aspira Scientific

2014 San Antonio Breast Cancer Symposium to Feature Oncotype DX® DCIS Study in Press Program on Friday, December 12

December 2, 2014 – 6:00 am | Edit Post

REDWOOD CITY, Calif., Dec. 2, 2014 /PRNewswire/ – Genomic Health, Inc. (Nasdaq: GHDX) today announced that positive results from the second large, independent clinical validation study of Oncotype DX® in patients with DCIS (ductal carcinoma in situ) breast cancer will be featured in the press program of the 37th Annual San Antonio Breast Cancer Symposium (SABCS) on December 12 at 7:30 a.m. Central Time (CT) in room 217D of the Henry B. Gonzales Convention Center. 

Conducted by the Ontario DCIS Study Group, the study demonstrated that the Oncotype DX DCIS Score™ predicted the risk of recurrence of DCIS or the development of a new invasive breast cancer in the same breast. The oral presentation of the primary analysis of the study results will occur on December 12 at 10:15 a.m. CT in Exhibit Hall D.

Results of additional studies will be presented as follows:

Wednesday, December 10

Abstract S1-06: “Stromal tumor-infiltrating lymphocytes(S-TILs): In the alliance N9831 trial S-TILs are associated with chemotherapy benefit but not associated with trastuzumab benefit.”Authors: Perez EA, Ballman KV, Anderson SK, Thompson EA, Badve SS, Bailey H, Baehner FL.Oral Presentation: Hall D, 10 – 10:15 a.m. CTThursday, December 11

Abstract P3-06-35: “Association of estrogen receptor (ER) levels and prediction of antiproliferative effect of hormone therapy (HT) in lower ER-expressing tumors.”Authors: Dixon JM, Turnbull A, Renshaw L, Rothney MP, Loman CA, Arthur L, Thomas JS, Young O, Murray J, Williams L, Sing AP, Cameron D.Poster Session: Exhibit Halls A-B, 5 – 7 p.m. CTFriday, December 12

Abstract P4-02-08: “Global quantitative measures using next-generation sequencing for breast cancer presence outperform individual tumor markets in plasma.”Authors: Beasley EM, Abramson RD, Alexander GE, Chan D, Bradley K, Collin F, Crager M, Dei Rossi A, Dorado J, Friedman A, Gibb WJ, Jeong J, Jones C, Ku CJ, Ma Y, Morlan J, Qu K, Rao A, Scott A, Tezcan H. Poster Session: Exhibit Halls A-B, 7:30 – 9 a.m. CT
Abstract P4-11-01: “Prognostic impact of discordance between different risk assessment tools in early breast cancer (Recurrence Score, Central Grade, K167): Early outcome analysis from the prospective phase III WSG-PlanB trial.”Authors: Nitz U, Gluz O, Kates RE, Hofmann D, Kreipe HH, Christgen M, Shak S, Clemens M, Kraemer S, Aktas B, Kuemmel S, Reimer T, Kusche M, Heyl V, Lorenz-Salehi F, Just M, Liedtke C, Wuerstlein R, Harbeck N.Poster Session: Exhibit Halls A-B, 7:30 – 9 a.m. CTSaturday, December 13

Abstract P6-08-06: “The Multidisciplinary Application of Genomics in Clinical Practice (MAGIC) survey: Identification of early stage hormone receptor-positive (HR +), HER2-breast cancer (BC) patients for whom multigene assays may be valuable.”Authors: Aapro M, Bargallo Rocha JE, De Laurentiis M, Elizalde R, Landherr L, Linderholm B, Mamounas T, Markopoulos C, Martin M, Neven P, Petrovsky A, Rea D, Rouzier R, Smit V, Svedman C, Thomssen C.Poster Session: Exhibit Hall C, 7:30 – 9 a.m. CTAbout Oncotype DX®The Oncotype DX® portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. The company’s flagship product, the Oncotype DX breast cancer test, has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer.  Additionally, the test predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS.  With half a million patients tested in more than 70 countries, the Oncotype DX tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment.  To learn more about Oncotype DX breast cancer tests, visit: www.OncotypeDX.com or www.mybreastcancertreatment.org.

About Genomic Health Genomic Health, Inc. (NASDAQ: GHDX) is the world’s leading provider of genomic-based diagnostic tests that address both the overtreatment and optimal treatment of early-stage cancer, one of the greatest issues in healthcare today. The company is applying its world-class scientific and commercial expertise and infrastructure to lead the translation of massive amounts of genomic data into clinically-actionable results for treatment planning throughout the cancer patient’s journey, from diagnosis to treatment selection and monitoring.  The company is based in Redwood City, California with European headquarters in Geneva, Switzerland. For more information, please visit www.GenomicHealth.com and follow the company on Twitter: @GenomicHealth, Facebook and LinkedIn.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the company’s belief that its tests optimize cancer treatment decisions; the company’s belief that its tests have redefined personalized medicine by making genomics an indispensable part of cancer diagnosis and treatment; the company’s belief that it is applying its infrastructure and expertise to lead the translation of genomic data into clinically-actionable results; the applicability of clinical study results to actual outcomes; the company’s beliefs regarding the benefits and attributes of its tests; and the ability of the company to develop and commercialize additional tests in the future. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: the risks and uncertainties associated with the regulation of the company’s tests; the results of clinical studies and their impact on reimbursement and adoption; the applicability of clinical study results to actual outcomes; the company’s ability to develop and commercialize new tests and expand into new markets domestically and internationally; the risk that the company may not obtain or maintain sufficient levels of reimbursement, domestically or abroad, for its existing tests and any future tests it may develop; the risks of competition; unanticipated costs or delays in research and development efforts; the company’s ability to obtain capital when needed and the other risks set forth in the company’s filings with the Securities and Exchange Commission, including the risks set forth in the company’s Quarterly  Report on Form 10-Q for the quarter ended September 30, 2014. These forward-looking statements speak only as of the date hereof. Genomic Health disclaims any obligation to update these forward-looking statements.

NOTE: The Genomic Health logo, Oncotype, Oncotype DX, Recurrence Score, and DCIS Score are trademarks or registered trademarks of Genomic Health, Inc. All other trademarks and service marks are the property of their respective owners.

Logo – http://photos.prnewswire.com/prnh/20130425/SF01493LOGO

SOURCE Genomic Health, Inc.

HealthTell Announces Receipt of an NIH/NCI Grant to Detect the Presence of Brain Cancer

December 2, 2014 – 6:00 am | Edit Post

SAN RAMON, Calif., Dec. 2, 2014 /PRNewswire/ – HealthTell™, an early stage Life Sciences company, today announced it has been awarded a $225,000 SBIR grant (1R43CA183360-01) from the National Institutes of Health (NIH) to evaluate the performance of the company’s proprietary Immunosignature™ Technology in accurately diagnosing brain cancer. This will include the specific diagnosis of glioblastoma multiforme (GBM), the most common and aggressive malignant brain tumor. The project, conducted in collaboration with the Biodesign Institute at Arizona State University (ASU) and Barrow Neurological Institute at Dignity Health St. Joseph’s Hospital and Medical Center, is regarded as highly significant as it addresses an unmet need for early, accurate, and non-invasive diagnosis and monitoring of brain cancers.

Currently, the detection of brain cancer requires imaging-based technologies, such as magnetic resonance imaging (MRI), followed by invasive needle or surgical biopsies for accurate diagnosis. Unfortunately, this method is very expensive, and not practical as an approach for brain cancer surveillance. HealthTell’s Immunosignature Technology has demonstrated the ability to measure a person’s immune response to brain cancer in an accurate and simple test. This test requires only a drop of blood from a patient. Once collected, the blood is placed onto proprietary peptide arrays where antibody binding patterns create specific disease signatures. The signatures offer highly accurate information about an individual’s state of health and have been used to detect more than 30 different infectious or chronic diseases.

“Applying the Immunosignature Technology to detect brain cancer has the potential to transform patient treatment and survival prognosis,” said Bill Colston, Ph.D., CEO of HealthTell. “Today, the average lifespan of a patient pathologically diagnosed with malignant glioma is approximately one year. A simple test which monitors changes in a patient’s immune activity will provide clinicians with a needed tool which will enable more accurate disease classification, simple monitoring of treatment and possible determination of disease recurrence. The goal of HealthTell is in alignment with the Affordable Care Act’s triple aim healthcare initiatives: to improve patient outcomes, experience, and health economics.”

The grant includes the opportunity for HealthTell to demonstrate the Immunosignature Technology’s ability to:

Detect brain cancer and distinguish it from other cancers. This distinction is important as the brain is often not the primary site of a brain tumor, but rather metastatic cancer from other sites such as the lung, breast, colon, or skin (melanoma). The American Brain Tumor Association estimates that up to 170,000 metastatic brain cancers are detected annually and this rate will increase as the population ages.
Differentiate brain cancer subtypes and identify grades of malignant gliomas, including the fatal GBMs. Subtyping and grading tumors is an important step in treatment. Some tumors, such as GBMs, do not respond well to radiation and can actually have adverse reactions, according to some research, whereas other gliomas respond well to radiation.”HealthTell’s technology is very powerful and we are demonstrating that it can provide information from a small blood sample,” says Adrienne C. Scheck, Ph.D., brain tumor researcher at Barrow, and co-investigator on the project. “It is likely to play an important role in the way brain tumors will be diagnosed in the future.”

“Barrow Neurological Institute treats more brain tumor patients than any other place in the US, which will strongly facilitate us moving successfully into clinical validation and commercialization,” said Dr. Kathryn Sykes, Ph.D., VP of Research at HealthTell, and principal investigator of this grant. “The opportunity to demonstrate the power of HealthTell’s Immunosignature Technology platform for application to brain cancer detection and monitoring will further validate its broad application to different diseases.”

About HealthTell

HealthTell is an early stage Life Sciences company that utilizes an Immunosignature™ Technology for accurate and timely detection and monitoring of more than 30 progressive diseases. Based on robust, proprietary technology, the company is developing the first and only diagnostic platform capable of assessing an individual’s immune system response to specific diseases. This disruptive technology enables physicians to detect the presence or absence of a disease in its earliest stage, improving patient outcomes and reducing healthcare expenditures. Applicable to a broad range of therapeutic areas, HealthTell is empowering physicians and patients to proactively manage one’s health and make more informed decisions. For more information, please visit: http://www.healthtell.com/.

About Barrow

Barrow Neurological Institute at Dignity Health St. Joseph’s Hospital and Medical Center is an internationally renowned medical center that offers care for people from throughout the world with brain and spine diseases, disorders and injuries. U.S. News & World Report routinely lists St. Joseph’s as one of the top 10 best hospitals in the nation for neurological and neurosurgical care.

Media Contact:Claire BakiMSLGROUP415-512-0770healthtell@mslgroup.com

SOURCE HealthTell

Tocagen Appoints Franklin M. Berger, CFA, to the Board of Directors

December 2, 2014 – 6:00 am | Edit Post

SAN DIEGO, Dec. 2, 2014 /PRNewswire/ – Tocagen Inc., a clinical-stage selective cancer immunotherapy company, today announced that Franklin M. Berger, CFA, has been appointed to the board of directors. Mr. Berger will also serve as the chairman of a newly formed audit committee responsible for overseeing Tocagen’s accounting, financial reporting, disclosure and financial risk management activities.

Mr. Berger is a biotechnology industry analyst with over 25 years of experience in capital markets and financial analysis. He previously served as managing director, equity research, and senior biotechnology analyst at J.P. Morgan Securities from 1998 to 2003. During this time he was involved in the issuance of over $12 billion in biotechnology company equity or equity-linked securities. These activities included Genentech’s IPO, the largest biotechnology financing ever executed, and the first large financings for Celgene Corporation and Gilead Sciences. Previously, Mr. Berger served in a similar capacity at Salomon Smith Barney.

“Franklin is one of the most respected and accomplished Wall Street investment professionals and advisors in the biotechnology industry today,” said Harry Gruber, M.D., chief executive officer of Tocagen. “We are pleased that Franklin has joined the board and Tocagen will benefit greatly from his expertise in finance, business and technology as we advance into the next phase of development for Toca 511 & Toca FC.”

Added Mr. Berger, “Tocagen’s potentially transformative gene delivery technology platform and highly differentiated product candidates stand out among cancer immunotherapeutics. The company’s initial indication, glioblastoma, arguably has the greatest unmet medical need in cancer today, and I look forward to playing a role in the company’s continued work to make a difference in the lives of brain cancer patients.”

Presently, Mr. Berger serves on the board of directors of Immune Design and Five Prime Therapeutics. He has served on the board of directors for numerous companies, including Seattle Genetics, Inc. Mr. Berger is a founder and managing director of FMB Research and previously co-founded the small-cap focused NEMO fund at Sectoral Asset Management.

Mr. Berger is a CFA charterholder, holds a master’s degree in business from Harvard Business School, and received a master’s degree in international economics and a bachelor’s degree in international relations from Johns Hopkins University. He is a founding fellow of the Biotechnology Study Center at NYU School of Medicine.

About Toca 511 & Toca FCToca 511 & Toca FC, the company’s lead investigational combination product, is being evaluated in three clinical trials in patients with recurrent high grade glioma, including glioblastoma. Toca 511 & Toca FC, an extended-release formulation of 5-fluorocytosine (5-FC), is designed to have a dual mechanism of action. Toca 511 delivers a prodrug-activating gene selectively to cancer cells. Then the prodrug-activating enzyme produced in the cancer cell activates orally administered Toca FC given in cycles, into a powerful antimetabolite, 5-FU, selectively in the cancer. In animal models, the production of 5-FU locally kills dividing tumor cells during each 5-FC cycle, which leads to durable and selective anticancer immune responses. Data from ongoing clinical trials show encouraging evidence for increased survival compared to historical controls, safety and tolerability, antitumor activity and evidence to support the proposed mechanism of action. Based on these data the company is now planning to commence late-stage clinical trials in patients with high grade glioma.

About Tocagen Inc.Tocagen is a clinical-stage selective cancer immunotherapy company pursuing discovery, development and commercialization of gene therapy drugs using a novel retroviral replicating vector platform, which selectively infects cancer cells. These therapies are designed to help patients fight their cancer by locally activating their immune system selectively against their cancer, with subsequent systemic benefit. 

Tocagen has received grant support from leading brain cancer foundations, including Accelerate Brain Cancer Cure (ABC2), National Brain Tumor Society (NBTS), American Brain Tumor Association (ABTA), Musella Foundation and Voices Against Brain Cancer (VABC). For more information about Tocagen or Toca 511 & Toca FC please visit www.tocagen.com or www.clinicaltrials.gov using the identifier NCT01470794, NCT01156584 or NCT01985256.

Media Contact:

Canale Communications Monica Maymonica@canalecomm.com

SOURCE Tocagen Inc.

More Biotechs Belly-Up These Days but Dendreon Still “One of a Kind”

December 2, 2014 – 4:31 am | Edit Post

Biotech companies rarely go bankrupt. Sitting where I sit, that bit of conventional wisdom comes around every so often, although it doesn’t generate quite the same buzz as Halley’s Comet…
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