NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

ski, the requirements for the marketing applications, applicant information, pre-clinical studies, clinical studies, product/manufacturing information, and labeling (the Common Technical Documents) are essentially the same in both jurisdictions, but the UK seems more willing to make exceptions and cut through the bureaucracy for approval, under certain circumstances, to speed an innovative treatment to patients with unmet medical needs. Maybe there’s less political and Big Pharma influence on the regulatory process and insurance reimbursement in the UK.

So now that Northwest Bio has an approved GMP facility in the UK with the ability to produce DCVax (in limited quantities), and since DCVAx meets the criterial for some of the new accelerated pathways in the UK, and holds a Promising Innovative Medicine designation by the MHRA, it makes sense (to me at least) to seek a marketing approval in the UK first.