Replies to post #563656 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Crossover can cause confoundment beyond what you imagine. Because Temodar interferes with t-cells, often causing premature exhaustion, the trx group in the trial used DCVax-l when the immune system was compromised, thus potentially making a less aggressive response. A less aggressive response, can potentially in turn result in a muted long term immunity, because the immune system thinks the cancer is not that big of a deal — in some cases.

Whereas, in rGBM, Temodar is stopped before DCVax-l is started. So when DCVax-l induced clonal expansion of t-cells occurs, those tumor killing t-cells can have an aggressive response, thus also creating better memory response and charging up the immune system, because no Temodar is there to stunt the immune response.

You also do not know what the OS differential is for the control versus experimental arm.

[Tartiaboy]

Yes I posted on SPPI boards for over 20 years. I sold out several years ago when I realized that the Amgen boys didn't know what they were doing.

Thanks for the further clarification. I actually popped in here mainly to say hello to Antihama. I've had many productive exchanges with him over the years. Among the best posters on these boards.

I'm a bit curious about the NWBO story especially as it relates to a true unmet need with GBM. The uncertainty about the phase III data coupled with the relatively high market cap are a bit off-putting for me at least at this point.

[Doc logic]

exwannabe,

What you conveniently forget to mention, amongst other things that I have highlighted in other posts, is that there were a greater percentage of long term survivors from the original treatment group than the rGBM crossover group. This in spite of the big advantage over the rGBM control group @ recurrence which included a few longer term survivors compared to none known for ECAs. This coupled with evidence from outside of this trial makes this an easy pass with regulators in an orphan disease especially when looking at how this will be used in combo or with adjuvants in the clinical setting.
Message board banter is one thing but I don’t think you would want to be on a regulatory committee with the public watching and try to justify a no vote. If you think Dr. Buzdar had it bad.... whew. Just sayin!; ). Best wishes.

[Doc logic]

exwannabe,

What you conveniently forget to mention, amongst other things that I have highlighted in other posts, is that there were a greater percentage of long term survivors from the original treatment group than the rGBM crossover group. This in spite of the big advantage crossover had against the rGBM control group which included a few longer term survivors compared to none known for ECAs. This coupled with evidence from outside of this trial makes this an easy pass with regulators in an orphan disease especially when looking at how this will be used in combo or with adjuvants in the clinical setting.
Message board banter is one thing but I don’t think you or anyone would want to be on a regulatory committee with the public watching and try to justify a no vote. If you think Dr. Buzdar had it bad.... whew. Just sayin!; ). Best wishes.