NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

dennisdave,

George Zavoico told me very recently that the approval will be based on the current manual manufacturing process, because that is what is included in the MAA.
He also said NWBio has been working on a closed and more efficient Flaskworks system, but that it must be fully GMP-compliant before it can be used.
According to him, once approval is granted, it becomes much easier to submit an amendment for the new closed manufacturing process.
This aligns with standard post-approval variation procedures for ATMPs."