Northwest Biotherapeutics Provides Update On Final Preparations For Marketing Authorization Application
Northwest Biotherapeutics Provides Update On Final Preparations For Marketing Authorization Application
BETHESDA, Md., Nov. 22, 2023 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, provided an update today about the final preparations for the Marketing Authorization Application (MAA) that will be submitted to the Medicines and Healthcare Products Regulatory Agency (MHRA)(the equivalent of the U.S. FDA) in the U.K. for commercial approval of the Company's DCVax-L treatment for glioblastoma.
马里兰州贝塞斯达，2023年11月22日 /PRNewswire/ — 开发针对实体瘤癌症的dcVax个性化免疫疗法的生物技术公司西北生物疗法（OTCQB：NWBO）（“NW Bio”）今天提供了将提交给药品和保健产品监管局（MHRA）（相当于美国食品药品管理局）的上市许可申请（MAA）的最终准备工作的最新情况。）在英国申请该公司治疗胶质母细胞瘤的dcvax-L疗法的商业批准。
The Company previously reported that one key section of the MAA package remained to be completed and to then be delivered to an independent publisher for quality control checking of citations, numbers, cross-references, formatting and the like, in preparation for the submission.
该公司此前曾报告称，MAA包中的一个关键部分仍有待完成，然后将交付给独立出版商，对引文、数字、交叉引用、格式等进行质量控制检查，为提交做准备。
The Company provided an update that most of the work has been completed on the key section of the MAA that remained to be done at the time of the prior update, as well as on required supporting documents, the majority of which have been delivered to the publisher/QC team. That team is now under way on this final stage of their work.
该公司提供了最新信息，即MAA的关键部分的大部分工作已经完成，而在先前更新时仍有待完成，以及所需的支持文件，其中大部分已交付给出版商/质量控制团队。该小组目前正处于工作的最后阶段。
As described in the Company's prior update, it is anticipated that the publisher/QC team will need several weeks to complete their work on both the last portion of the MAA package and the integrated whole. Their work is independent of the Company.
正如公司先前更新中所述，预计出版商/质量控制团队将需要几周时间才能完成MAA软件包的最后部分和综合整体的工作。他们的工作独立于公司。
About Northwest Biotherapeutics
关于西北生物治疗公司
Northwest Biotherapeutics is a biotechnology company focused on developing personalized immunotherapy products designed to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis, in both North America and Europe. The Company has a broad platform technology for DCVax dendritic cell-based vaccines. The Company's lead program involves DCVax-L treatment for glioblastoma (GBM). GBM is the most aggressive and lethal form of brain cancer, and is an "orphan disease." The Company has completed a 331-patient Phase III trial of of DCVax-L for GBM, and the results have been presented in scientific meetings and published in JAMA Oncology. The Company has also developed DCVax-Direct for inoperable solid tumor cancers. It has completed a 40-patient Phase I trial and, as resources permit, plans to pursue Phase II trials. The Company previously conducted a Phase I/II trial with DCVax-L for advanced ovarian cancer together with the University of Pennsylvania.
Northwest Biotherapeutics是一家生物技术公司，专注于开发个性化免疫疗法产品，这些产品旨在在北美和欧洲以具有成本效益的方式比目前的治疗方法更有效地治疗癌症，不产生与化疗相关的毒性。该公司拥有基于 dcVax 树突状细胞的疫苗的广泛平台技术。该公司的主要项目涉及胶质母细胞瘤（GBM）的dcvax-L治疗。GBM 是最具侵略性和致命性的脑癌，也是一种 “孤儿病”。该公司已经完成了一项针对GBM的dcvax-L的331名患者的III期试验，结果已在科学会议上公布，并发表在《JAMA Oncology》上。该公司还为无法手术的实体瘤癌开发了DCVax-Direct。它已经完成了一项40名患者的I期试验，并计划在资源允许的情况下进行二期试验。该公司此前曾与宾夕法尼亚大学一起使用DCVax-L进行了一项针对晚期卵巢癌的I/II期试验。