Here is the significance of the December 15th MIA Certification to the MAA review completion.
1. Final, Commercial Regulatory Sign-Off This new MIA (Authorization Number UK MIA 54923, Human Medicinal Products Legal Basis) specifically grants Advent BioServices, now a wholly-owned subsidiary of NWBO, the commercial manufacturing authorization required to produce DCVax-L for sale.
The MAA is comprised of three main modules: Clinical, Safety, and Quality (Manufacturing). The final MHRA inspection and subsequent grant of this commercial MIA on December 15th essentially closes the book on the Quality (manufacturing) module.
The MHRA will not issue a final grant letter for a new drug until they have confirmed the commercial manufacturing site is fully compliant. This MIA is the official documentation confirming that the facility meets the Good Manufacturing Practice (GMP) standards required for commercial launch, imo.
2. Removing the Final Review Blockade With the MIA now secured, Northwest Biotherapeutics has likely cleared the last major regulatory bottleneck required for a final decision.
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