NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Optune wasn't even blinded, so actually their "retrospective" data is garbage in, garbage out.

This is from Memory.

1. November 2014 Optune enrollment ended.(Trial had never been blinded)
2. November 2014 Optune crossed over (halted trial) all placebos to the Optune arm.
3. Halt was based on only half the trial population analysis.
4. December 2016 was final analysis (trial was never blinded) because only 10.3% of patients in ITT group still alive only two years after trial enrollment completed. No more patient follow up.
5. Approximately 2018, NICE stated Optune asking something like 6 times too much for their product because they had no long term survival data.
6. December 2018, Despite stopping patient follow up back in December 2016, Optune wanted to project from its old data from December 2016 how many patients that wore the helmet more than 90% of the time might be alive at five years. They guessed this would be about 12 patients out of the treatment arms 466 patients (out of the 43 of who wore the hemet 90% of the time or more) . They don't know, because they don't want to count the number alive today. They just use guesstimates, even though we are only four years out from the end of the trial.

Note: Optune's trial enrollment ended only one year earlier than NWBO's enrollment, but because Optune acts like chemo attrition, and therefore its good effects occur on the front end of the trial, they wanted to stop doing follow up soon thereafter. Just 24 months after enrollment completed in the Optune trial, 12% of Optune patients were alive and 7% of control. But more than that. The control were starting to close the gap at the last analysis, so that was that and all follow up stopped. Now, they are going back and digging through their trial for things they can project. Imagine, one of the patients they projected to be alive today at five years post enrollment had only been in the trial 24 months with the data they used.

If Optune are going to bring out these PRs, they ought to be forced to give the true meaning of retrospective data. They ought to have done another count instead of made it sound like real new data. IMO.

My guess is there are only one to two percent of patients still alive today from the entire 695 patient population. This being only four years out from when Optune closed enrollment, but again, they won't provide that count.