NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

I believe that the journal and preparation for the process of seeking regulatory approvals are on separate tracks.

Yes for MHRA perhaps not for FDA approval...

If its true the JA is being held up because (some) journal reviewers have questions and or concerns with the ECA comparison being used. Probably because the FDA has still not set it as a regulation rule in stone. (Yes the FDA accepted the endpoints/SAP by not objecting to the submitted SAP as dr Liau stipulated). Anyway, if the JA is being held up for that reason, then I believe NWBO wanted to overcome that obstacle by asking the FDA explicitly in black and white to greenlight the ECA comparison for this trial.

If that is the case then there is a clear parallel between the JA publication and DCVAX L approval in the US. After the FDA has let Northwest know in black and white writing that the ECA comparison has their blessing then that is a huge step forward in the FDA time-consuming approval process AND would greenlight the JA publication at the same time.

That's why Northwest keeps saying it's out of our hands. That's why we keep hearing it could be any moment now. A huge disadvantage is FDA communication could take many months. The question is also when did NWBO ask the FDA for a green light in black and white writing on the ECA comparison. Probably when they learned journal reviewers had a problem with the ECA comparison.

IMO that is what is going on and IMO that's whats holding up the JA, IMO this is a parallel between FDA approval and JA publication.

Looking forward to hear your opinion Senti