Replies to post #763995 on NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

Gal,

Thanks for posting your astute analysis to enlighten us all 😶

Let’s assume you’re correct about ECAs…
How about the placebo-controlled RCTs—are those relevant to anyone? How about the compassionate use data? And why would MHRA have approved the PIP if they thought the design was ‘questionable’ ??(Notably, trial design changes were not requested by MHRA—the design was approved for GBM.)

DCVax-L (and the Roswell DC technology) are currently in placebo-controlled RCTs.

You can find links to those active RCTs here:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=176001390

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=176114523

[learningcurve2020]

15-20%? I think you really have to question that old 5% survival figure. More likely between 7.5 to 10%. vs. L’s 13%. based on the many articles I’ve posted here.

[learningcurve2020]

I think the questions remain about the initial selection criteria. I’ve always said here a confirmatory trial is most likely but I disagree it’d need a control group given the advance in scanning. Perhaps a SurvaxM control?

>>It's possible there are questions about the control used here, but I feel that the most dire consequence this should lead to, in my opinion, is requiring another confirmatory trial with an enrolled control group, not an external comparator.

[exwannabe]

It's possible there are questions about the control used here, but I feel that the most dire consequence this should lead to, in my opinion, is requiring another confirmatory trial with an enrolled control group, not an external comparator.

The trial was randomized to 232 with -L + SOC vs 99 with placebo + SOC. Primary endpoint PFS secondary OS.

OK, the PFS failed and no argument that psPD could be a cause.

But the OS between the arms showed no improvement. We do not know the trend, but the fact that NWBO has refused to disclose that number makes i.t clear it is not good.

So knowing this, years after the trial was over. they changed the comparison to be against and external control arm that was a mixture of several trials summary data. Not even patient level data.

I could go on, but it is pointless as the above is enough to make clear they have issues.

EDIT:

As a side bar, when the FDA placed a hold on the trial after the efficacy IA in 2015, NWBO said they hoped to get recruitment restarted soon. Never happened so the trial never completed planned enrollment. Should be kind of obvious what happened.

[attilathehunt]

is requiring another confirmatory trial

Seems to me, with all the data and the safety profile of DCVax-L doing a confirmatory is a death sentence to those it may benefit.

Why not do something similar to a P4 trial? Conditional approval with future data requirements. This would be a win-win for all!!

It's safe, so no issue of harming anyone and the potential to prolonging the lives of many!

Simple enough.