Northwest Biotherapeutics 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.
| BETHESDA, Md., Nov. 22, 2023 /PRNewswire/ -- Northwest Biotherapeutics, Inc. (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.
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. 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. 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. About Northwest Biotherapeutics 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. Disclaimer Statements made in this news release that are not historical facts, including statements concerning plans for DCVax are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “expect,” “believe,” “intend,” “design,” “plan,” “continue,” “may,” “will,” “anticipate,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those projected in any forward-looking statement. Readers should not rely upon forward-looking statements. There are a number of important factors that could cause actual results to differ materially from those anticipated, including, without limitation, risks related to delays or uncertainties in regulatory processes, risks related to the Company’s ability to achieve timely performance of third parties, risks related to whether the Company’s products will be viewed as demonstrating safety and efficacy, risks related to the Company’s ongoing ability to raise additional capital, and other risks included in the Company’s Securities and Exchange Commission (“SEC”) filings. Additional information on the foregoing risk factors and other factors, including Risk Factors, which could affect the Company’s results, is included in its SEC filings. Finally, there may be other factors not mentioned above or included in the Company’s SEC filings that may cause actual plans, results or timelines to differ materially from those projected in any forward-looking statement. The Company assumes no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by securities laws. CONTACTS Northwest Biotherapeutics Dave Innes Les Goldman
SOURCE Northwest Biotherapeutics | ||
Company Codes: OTC-BB:NWBO, OTC-PINK:NWBO, OTCQB:NWBO |
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