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[【学科前沿】] Health Canada allows Isotechnika to continue patients on ISA247

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发表于 2007-8-2 13:17:30 | 显示全部楼层 |阅读模式
Isotechnika (Edmonton) announced that the Company has received a No Objection Letter from Health Canada for the long term use of ISA247 in patients currently participating in the Canadian arm of the Company's Phase 2b kidney transplant trial. The No Objection Letter allows patients to remain on ISA247 through to commercialization of the drug and beyond after completion of the 12 month Phase 2b trial. Patients choosing to remain on ISA247 therapy will continue to have safety and efficacy parameters monitored on an ongoing basis. A similar protocol amendment for the long term use of ISA247 has also been submitted to the Food and Drug Administration of the United States
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