Replies to post #158204 on NorthWest Biotherapeutics Inc (NWBO)

[marzan]

Thanks SOS! Your simple comparison of projected DCVax blended OS patients alive at year 2, 3, 4, and 5 as opposed to typical SOCs are >30%, >15%, >8%, and >5% respectively. If the Longs and Bears or anyone in this subject see this really happening in our trial because after about 28 months since the last patient enrolled in Nov 2015, we have 85+ patients still alive which is easily >25% of the overall enrollment of 331 at year >2.3, the worst case considering all 331 patients enrolled on the same day in Nov 2015. If the reader understands this simple fact, then they will realize an FDA approval is already in the bag. Thanks for your continued articles and long theory.

[TiltMyBrain]

Thanks Larry!

[Diamondjim61]

Thanks for all your DD Larry.

[flipper44]

“The last patient enrolled in the trial over two years ago so that the chance of that last enrollee being alive at two years if treated with SOC would be 30%. For all other patients, the chance of being alive at this point in time would be much (much) less assuming they were on SOC. — Larry Smith

.... And now we are at approximately 27 months from the last enrollment, where standard of care would be at about 25% chance of survival for last enrollee, and as you point out, for other patients, the chance of being alive would be far less assuming they were on SOC, since most patients were enrolled over three and a half years ago.

I’d add that the removal of early psPD from this trial likely means SOC Chance of survival at 27 months for hypothetical last patient enrolled would be closer to 10%.

[AVII77]

I believe that the survival tail of DCVax-L. will be more critical to regulatory approval than proscribed endpoints of mOS and mPFS.

Maybe your analysis would have more credence if you understood the primary and secondary endpoints.

They are NOT mPFS and mOS.

The "proscribed endpoints" are PFS and OS.

And that is measured using a log rank test.

It is possible to have equal mPFS in both arms and still have a significant difference in PFS.

The fact that you fail to recognize this, combined with the fact you don't even understand how the endpoints are measured, renders your analysis worthless. Actually, worse than worthless; your analysis is misleading.

Furthermore, your claim that a 2.5 month improvement beyond a historical control of 16.5 months would be "quite positive" is absurd. With 233 OS events that wouldn't even be Stat Sig in a 2:1 randomized trial. Not even close (they would need over 1750 OS events to have just 80% power).