Replies to post #707809 on NorthWest Biotherapeutics Inc (NWBO)

[iclight]

It's NWBOs problem that they couldn't design a proper trial. They had patient level data for the control arm. The one they designed into the trial! Liau has literally given presentations on pseudoprogression since 2013. When they changed the size of the trial, she should've changed the endpoints before every patient was enrolled and dosed. Yet they waited til the majority were deceased.

Roger Stupp, of Stupp protocol and Optune fame, was hired and apparently signed off on this himself.

Total bullshit. If you are gonna talk about Stupp, how about linking to his brief comments about all the problems with the results?

To say Stupp "signed off" based on this is absurd:

The outcome is reported from randomization (day 1 of vaccination), which occurred over 3 months after initial surgery, during which time patients were treated with standard temozolomide and radiation and underwent apheresis and vaccine production. This 3-month interval inevitably leads to a lead-time bias — patients with the worst prognosis progressing within 3 months of diagnosis were not included.

All patients had undergone prior tumor resection (fresh tumor tissue was required for vaccine production!), and, in the “historical control” trials, up to 13% of tumors were nonresectable.

And this quote sums up Stupp's "signing off":

The results are intriguing; yet, it remains to be demonstrated that the effect observed is truly due to DCVax rather than a mere reflection of patient selection.

[HyGro]

Except for the 8 peer reviewed articles that challenge the legitimacy of the clinical trial revisions done 2 weeks before the completion of the trial.

Totally new comparator (one required to be approve BEFORE the trial started), change the protocol, endpoints, and experimental design. All were well detailing in these publications.