regulatory path in the first half of 2017. Overall Summary of Results of BP-004 Study with BPX-501 (n=85) The Company presented a review of results to date http://felonfuld8rr.nanobits.org/professional-tips-on-common-sense-methods-in-interview of the BP-004 study in pediatric patients with malignant and nonmalignant diseases who underwent a haploidentical hematopoietic stem cell transplant (HSCT) followed by an add-back of genetically modified BPX-501 T cells. Eighty-five patients have been treated with BPX-501 at multiple U.S. and European sites and followed for at least 100 days (out of a total of 105 patients treated to date). Only one case of transplant-related mortality has been reported, unrelated to BPX-501 cells, and none out of 51 patients with nonmalignant disorders. Compared to T-depleted haplo-transplants alone, results have also shown significantly faster immune recoveries, as well as reduced viral infections and reactivation, and reductions in time to hospital discharge and re-hospitalizations due to infection. In five cases where uncontrolled acute GvHD was attributable to BPX-501 cells, rimiducid was administered and symptoms resolved. Results have been consistent across a range of diseases and disorders where allogeneic HSCT is recognized as curative, including hemoglobinopathies such as Beta Thalassemia Major (00), Sickle Cell Disease and Diamond-Blackfan Anemia; Primary Immune interview skills monster Deficiencies such as Severe Combined Immune Deficiency (Bubble boy disease) and Wiskott-Aldrich syndrome; leukemias and lymphomas; and bone marrow failure syndromes. The Company also reported that of six refractory AML patients treated under compassionate use because of their active disease and not included in the BP-004 summary data, 4 remain alive and in remission, including two who are now 11 and 20 months post-transplant. RegulatoryUpdate for BPX-501 in the European Union The Company also announced today that the protocol assistance provided by the European Medicines Agency (EMA) for the registration study of BPX-501 in Europe is complete, and the Company is finalizing plans for the BP-004 trial extension. The Company will continue enrolling up to 40 additional patients with malignant and nonmalignant diseases in the trial.
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<img src="http://img.pr.com/release/1611/170275/pressrelease_170275_1480561009.jpg" width='250px' alt='Joseph Nawa of New Day Underwriting Managers Addresses Environmental Risk Profile Trends & Practices at http://www.datarr.com/stinterview/2016/12/15/emerging-guidelines-for-rational-secrets-of-interview/ IRMI Construction Risk Conference’ align=’left’ /> This included highlighting the potential impact of specific exposures, the coverage types available in the marketplace to minimize financial damages and the variations in policies among the industrys numerous carriers. Risk management provides an excellent method for protecting against the potentially catastrophic environmental liability issues faced by firms during the construction process, said Nawa. It is essential to thoroughly understand the underlying consequences and potential financial repercussions before the contract is even signed, through every building phase, and even beyond completion. Delivering his comments during two separate presentations, Nawa examined the entire risk management process beginning with a review of the organizations operations and extending to the identification of environmental exposures that exist on jobsites, owned or leased premises, during transportation, or after the disposal of waste. Among Nawas recommendations was a four-pronged approach for helping contractors to recognize potential exposures as well as manage and transfer the risks once they occur: –Education. Employers should consistently educate employees regarding the exposures faced on a day-to-day basis, while providing certified training and jobsite walkthroughs –Contract Language. Request environmental disclosure statements from the project owner as well as contractual language that includes pre-existing contamination clauses, change in conditions provisions and environmental insurance requirements –Administrative Controls such as visual inspections, sample analyses, audits, etc. –Risk Financing or Risk Transfer Alternatives. When researching the appropriate contractors pollution liability coverage, carefully consider the size and potential environmental impact of the project or firm as well as the integration of the appropriate limits given the projects financial scope, size and expertise, experience and credentials of the other parties involved When in doubt, seek professional advice and guidance in establishing a risk management approach to environmental exposures, adds Nawa. Never underestimate the financial impact of potential problems.
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