NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

dennisdave,

While I agree with you about this concern, I believe MHRA will only require a good faith gesture with a GMP, initially validated manufacturing unit because of the importance of the product meeting an unmet need. This is speculation, of course, but NWBO has stated that MHRA is and has been working closely with them. The other way to gain UK approval would be to only approve for GBM orGBM with artisan as a kind of boutique approval then seek approval with Flaskworks for everything else later after full commercial scale validation of Flaskworks. That would not be the best for patients or investors but would likely meet the pathway standards you are pointing to. I’m pretty sure they have already thoroughly discussed this. Best wishes.