Replies to post #65738 on NorthWest Biotherapeutics Inc (NWBO)

[sentiment_stocks]

Couldn't the EAP kinda sorta serve as a confirmatory trial for the mesenchymal group? It will have plenty of pseudos in it. Anyhow, if it can't, then perhaps they filed for a BLA for mesenchymal.

And remember, while the number of randomized patients may only be 32... they've got all the pseudos in the open EAP trial that they can also submit the data on. AND... if there were pseudos in the Indeterminate Arm... as all of you who aren't invested insisted there were... then they could have done a subtype analysis on those patients, and if they were mesenchymal... submitted their data too.

And guess what? They don't need to PR any of that.... so long as they keep it nice and secret. In fact, it's best for them not to... if that's what they did. If they are refused... no worries. If they get it, then it's really no worries. :)

Because then they can PR it. :)

[Doc logic]

exwannabe,

Two things to consider from your post. The first is that you said you believe that the blinded pseudo trial can help with full approval for the main trial. The second is that there are 2 types of pseudo progressors.

With regard to your first point about the pseudo trial helping the main trial I agree. Not only can these results be added into a successful Phase 3 but this can also act as a balancing of subtypes to reflect a non biased patient population which is important to the expected outcome for the general GBM population. This is especially true if most or nearly all patients can benefit to varying degrees based on subtype or changed phenotype at progression with pseudo progressors being those likely to receive the best outcomes but others helped as well.

With regard to the second point about early and late pseudo progressors, the data will be stratified enough to demonstrate how the timing of pseudo progression as it relates to SOC radiation treatment alone vs late radiation response/DCVax response affects outcome. This is because early pseudo progressors would be mainly in the separate blinded study and any late pseudo progressors would be in the main Phase 3 trial. The data from these 2 sets of pseudo populations could be considered confirmatory for all pseudo progressors with enough confirmatory response rates could it not? How do you think this would relate to the old arguments about data mining for subgroup populations and alpha spend reserve built into the main trial? Something to think about. Best wishes.