Replies to post #594773 on NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

HL, if NWBO has the agreement with the four regulators to participate in a program where they all work together, I believe it's possible that the submission to all four can't be made until all four are satisfied that the company can meet initial commercial production demands. We know that the UK can be satisfied with manual production at Sawston based on the MIA. As for the other 3 regulators, we don't know with certainty what's demanded, but it may require the acceptance of the EDEN unit, and could very well require a commercial producer, like CRL, licensed to achieve this production.

I don't believe NWBO is going to announce precisely what they're doing until it's done. When the EDEN unit can do the job I believe they'll announce filing for approvals and an agreement with CRL in addition to Advent to produce commercial product. Both facilities will be the subject of inspection by the regulators for commercial production. As for not yet submitting the MAA, it may be based on the agreement of the four regulators to work together. I believe we're close, but don't know if that means next week, month, or quarter, but whenever it is, it's happening.

Gary

[CrashOverride]

Balderdash. Management has certainly shared data with regulators otherwise how else could MHRA approve the PIP?

Back and forth discussions with regulators are not disclosed. Drug approvals are largely private. Though any negative feedback would require a disclosure. We have had nothing but good news.