Replies to post #293506 on NorthWest Biotherapeutics Inc (NWBO)

[hankmanhub]

Unfortunately LL is not the FDA, Now if the FDA had said that - now you have a point.

[longfellow95]

The point regarding efficacy against particular subtypes being considered for approval is supported by the comment Dr LL made right after she stated everyone is living longer.

Paraphrasing, she said that there should be an approval path (which I took to mean at least for the subgroup(s) that appear to be benefiting like never before.

Depends whether you think (in respect of each comment) she is talking about the DCVax trial, or GBM trials in general, or maybe immunotherapy trials in general.

And if she thinks 'everyone' is living longer, then that actually sounds like she is suggesting across the board benefit. And if that is what she thinks, then why would she in the next sentence talk out about approval for subgroups?
Of course, Dr Ashkan also remarked that there is benefit to all.

The only real question (for me at least) is whether the data emanating from this trial, will support regulatory application for all of ndGBM or just meth.

(For sure, there has to be a more general move to reliable predictive biomarkers in the years to come. We've known for years that the majority of patients receiving ICI treatment derive no significant clinical benefit. But which Big Pharma is going to rush ahead with predictive biomarkers that effectively cut down their market size? They want to increase market penetration, not reduce it.)