On November 22, 2023 Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, reported an update 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 (Press release, Northwest Biotherapeutics, NOV 22, 2023, View Source [SID1234637934]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.