NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

I do not think that is true Hyperopia. Companies use outside companies during trials all the time. Multiple sites sometimes. I suspect there is less or more to this than perhaps we are discussing, but perhaps less particularly.

In this case NWBO has used multiple sites repeatedly for trials involving DCVax, and I doubt with comparability studies just because they were different locations. London, UCLA, Cognate’s HQ, and now Sawston. The most variability is likely with the different locations doing it manually. And likely they already have measures they use to ensure consistency regardless of location.

Updated procedures are not intended to make them do ridiculously competitive or oddly constrained comparisons, which I suspect that would suggest given the reality in this case already.

For NWBO it likely is best to do it in the same location just as a control as they try to ensure the least variability, so it might be best practice. However, they did not have to be approved to provide the drug to patients to begin the runs necessarily either, since Flaskworks is not approved yet anyway and they do not need to do human testing, at least as I read the requirements, generally, though of course regulators can be more demanding than the basic rules might absolutely require. They always reserved the opportunity to use their regulatory discretion.

Of course all IMHO, and I’m not saying they will be approved to use Flaskworks tomorrow, only that it may not take until early or mid-2023 necessarily. We’ll have to see. I think presumptions that it will take a very long time may be flawed, and not up-to-date with what I have read. And of course I could be wrong.