Replies to post #500675 on NorthWest Biotherapeutics Inc (NWBO)

[hoffmann6383]

DCVAX-L will be approved for rGBM no matter what false narratives are pushed. I prefer to listen to the experts over nonsensical narratives.

have a good one hygro

[newman2021]

You are a broken record. If you don't buy the rGBM arm, then go read the 2018 JTM blinded paper or the blended arm where the results excelled the SOCs as well. OS is the Gold Standard. PFS is for those who can't run the trial too long to collect OS data; plus PFS doesn't work well in immunotherapy but it is something every trialist wants to see on top of collecting OS data these days. LL et al are trying to find a way to stop the immunotherapy trial early on using some PFS techniques and I think they are testing their method in their combo study with a PFS measure and OS as well that you are quoting. See the listing and stop fuding spreading false image that they are only measuring PFS. They are also measuring OS as the trial started in 2020 and projected to go till 2025. Stop FUDs.

https://clinicaltrials.gov/ct2/show/NCT04201873

[sentiment_stocks]

Your explanation (cited below) as to what was the cause of the confoundment in the OS arm is incorrect.

NWBO has called their OS data confounded by the crossover as some patients that were DCVax-L dosed were redosed if they were pseudo-progression and therefore received multiple doses. It they had true progression they also had a 2nd dose. That would the confound the reading of the naïve GBM OS arm. That's where the FDA may find the results are questionable because of the multiple dosing that could increase the OS rate. When a placebo treated patients did not have multiple doses

OS is confounded because the randomized control arm received the treatment as well. So the control arm became part of the treatment arm upon crossover due to their recurrent GBM… thus resulting in a confounding of the OS endpoint. It becomes more difficult to compare the two arms when everyone receives the treatment, and for that reason, and in the words of our esteemed and brilliant Linda Liau, “everyone is living longer.”

Additionally all patients (treatment and crossed over to treatment controls) who survived long enough would have received the entirety of all their DCVax-L treatments.

[foxhound02]

You seem to have some understanding of what happens when FDA turns loose their pack of statisticians on a BLA.

[dr_lowenstein]

thanks, FDA hates data dredging