Replies to post #53518 on NorthWest Biotherapeutics Inc (NWBO)

[Evaluate]

Rindopepimut is an investigational immunotherapy for EGFRvIII-positive glioblastoma.
I get the impression this "EGFRvIII-positive" might be involved in about 25% of GBM cases?

So if this treatment were to be found extremely effective & approved, then would this possibly reduce NWBO potential market share for DCVax-L by 25%, if it is not found to be equally or more effective?

And what about DCVax-L appearing to be highly effective in GBM cases of "mesenchymal gene-expression signature"?
Do "mesenchymal gene-expression signature" & "EGFRvIII-positive" overlap?

So if Celldex were to get their product approved prior to DCVax-L based on it being say marginally more effective than SoC, but then DCVax-L is found to be especially effective for mesenchymal patients .... could DCVax-L knock Celldex product out of first position in regards to treating patients who might have "both" EGFRvIII & mesenchymal?

[Doc logic]

flipper44,

This KLH/placebo observation in the CLDX Rindopepimut trial you allude to might be the critical difference to trial success that has Adam on edge. His support of CLDX, and most of his recommendations for that matter, has much to do with the business end and not necessarily a good understanding of all the key components of the science utilized in each trial. That constant level of detail would keep him from being able publish with a wide net about so many biotechs. I believe one of the reasons he is here, though not the main one, is for the discussion of the science which is fascinating.

Dr. Linda Liau, in a round about way, really seems to be focused in her video presentation on the OS endpoints and how FDA will react to obvious synergistic effect seen between chemo, radiation, DCVax and perhaps TLR agonists with the parallel trial. There may even be crossover cures being seen with use of checkpoint inhibitors. Adam wants to paint all of this as a negative by assuming that FDA will be dogmatically rigid if the trial does not actually exceed primary endpoints and or provide a clear secondary endpoint separation of at least 2 months benefit in OS. This is fine to suggest as a possibility but FDA guidelines indicate to me that the 2 month OS benefit alone would be sufficient in GBM since there is a great deal of supporting evidence from multiple sources that DC treatments create synergistic effect.