NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

HyGro,

The MIA approval (commercial scale manufacturing UK) must happen BEFORE MAA approval. FDA also requires proof of ability to ramp up to expected demand levels before any BLA can be approved and that proof can be submitted during the course of a rolling BLA application especially if one method is being exchanged for another during the submission period leading to a completed BLA.
The building and use permit at the Memphis site for Cognate/CRL has publicly established plans for a massive expansion next year in line with expectations for an approval of a new, high demand cell based product. Commercial scale readiness has been moving at a rapid pace ever since the time that the company would have been unblinded which is also the time when loans were granted to NWBO for funding of ongoing operations. In days to months what is obvious to thousands will be obvious to millions which means no stopping NWBO then. Best wishes.