Replies to post #719558 on NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

Still, the fact that the DCVax-L ECA did not offer patient level data could represent a problem, but yet what I presented is that there is another guidance that indicates it might not be.

so yeah exactly. In June and July, I have been going back and forward with this with Exwannebe and where he first claimed its impossible I made the case as you did that the door is open not shut. Now ex claims its difficult, and I have to agree with him, it is difficult and a concern to get approval for an ECA-based BLA where A. the sponsor did not provide the ECA trial design before the medical trial started, and B. there is no individual patient-level data present.

Im not saying its impossible Im saying its concering. Much more important than our opinions is Dr Liau who is on record saying that she thinks (my words) that the FDA's attitude toward the proposal to have individual patient-level data in rare disease medical trials included, is intolerable. The American Brain Tumor Association is ofcourse right that maintaining a control arm where patients die so they can be compared (as ex wants to see it) with the treatment arm is unbearable and not something that would fit in 2024.

Now did NWBO get a free pass on the subject? Why would Dr Liau recently complain about the subject if they did? I think this uncertainty is the main reason why NWBO has not submitted a BLA with the FDA yet. I believe that either big pharma will have to submit the BLA after acquiring NWBO and convince the FDA of its stubborn impossible position on the matter or that NWBO will have to redo the trial in the US with a pre-approved SAP design after EMA and UK approval...