Replies to post #545964 on NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

I'm frankly saddened by the qualified people who continue to ignore the advancement of DCVax-L, not based on the Phase 3 alone, but based on what it's capable of based on the Phase 1 and 2 trials being run at UCLA and elsewhere. Even if DCVax-L by itself had no benefits, which it clearly has, it's the key to so many other therapeutics having benefits, ignoring that disturbs me more than their trying to defend the technologies they helped developed vs. DCVax-L alone.

I know that in approaching the regulators NWBO can't yet highlight, or even mention, the benefits seen by the likes of Keytruda in combination with DCVax-L, but they don't have to. The regulators aren't blind to what's happening, I cannot imagine any of them delaying approval once production issues are resolved.

Gary

[scotty3371]

Go Flipper!!

[iclight]

He doesn't know any of this. He is a stand up guy and NWBO assumed because they paid him he would lie. He took an oath to "do no harm" and that includes hyping this placebo.

What he does know, is the mOS got worse when they removed the placebo patients.

The trial got a futility recommendation after the IA in 2015.

The trial's comparators are to other trials that had biopsy only patients which would certainly skew their results in favor of the trial that excluded ALL OF THEM.

Optune is approved.

He doesn't benefit financially if NWBO admits the trial is actually a failure.

Every treatment has long term survival patients. Including SOC.

[sentiment_stocks]

Also, I wonder why he didn’t clarify the reason assessing PFS was so difficult? He could have easily written that it was due to pseudoprogression.

During the conduct of the trial, the limitations and difficulties of assessing progression-free survival became apparent, and, after completion of enrollment, the initial design was modified to restrict analyses to the overall survival outcomes of the 232 patients initially randomized to DCVax, which were to be compared with pooled historical control data inferred from published data.