NorthWest Biotherapeutics Inc (NWBO)

[maverick_1]

Longfellow95 re: Let's not forget that the actions of the FDA have been instrumental in hamstringing this trial.
Firstly, by the apparent insistence on a crossover. This was where potential confoundment first came in.
Hindsight is wonderful, but this is when NWBO should have taken a raincheck.
With a planned ratio of 2:1, control arm size was already considerably smaller than ideal: add in a crossover and you also no longer have a clean OS comparison.
At that time, they perhaps should have gone for 1:1.
Or do what BMY did in 548. Start off with an OS primary, so no crossover, then change to a PFS primary down the line, when it is too late to have a crossover.

Then, an issue arises mid-trial leading to a recruitment hold.
FDA allows further recruitment to treatment, but not to control.
And prolongs the hold indefinitely, to the point where NWBO announces they can no longer keep recruitment open, due to all the logistics and expense.
Then and only then, the FDA lifts the hold. This further skews the ratio and caps the numerical size of the control arm to 99.
Too small..(From a powering point of view, it would have been much better if the recruitment post the start of hold, had all been to control.)
Thereby robbing the trial of chunks of statistical power.
The additional powering afforded by the 2014 enhancements is robbed away completely.

Quote:
And then we have the independently powered game Dr B played om longs. Standard primary/secondary are independently powered. Dr B tossed this out because he knew longs would spin it to assume incorrectly it implies co-primaries. Disgusting.


Well, the 2014 enhancements already suggested that alpha spend had been split with reference to a p=0.02 PFS spend.
So, Dr B's comment may have been a simple statement of fact.

I view the FDA actions in relation to this trial with considerable cynicism and distaste, and 'bad actor' comes to mind..

Still, a rigorously adjudicated PFS will be clean, but a sizeable delta will be required to achieve nominal stat sig.

Vote for this being a STICKY!

Thank you for validating my previously expressed sense of your thorough, investigative, cloud piercing and EXCULPATORY abilities.

I may be corrected, BUT have NOT seen to date anyone on this board DO since 2015 what you've expressed above.

Longfellow95 has done more IMHO and in ONE post (vs the rambling regurgitation of MB's) to integrate and synthesize on the scientific end and behind the scenes than what I have witnessed in terms of the clear WAFFLING uncertainty....all of us have witnessed by bully pulpits since 2015. Luckily I, for previously expressed long list of reasons, exited at close to the highs vs the multitudes that have lost their life savings (very different than those who are still here to recoup!).

ALL of the above should reasonably explain the extreme angst and expressed anger which is totally MISDIRECTED here of really SELF INFLICTED DAMAGE caused by INCOMPLETE, ongoing due diligence.

I also have witnessed based on my own investigatory work, the SAME shared sense with Longfellow95 about the corrupt biasness of the FDA courtesy of AMRN's Vascepa for which I , and may others here are being richly rewarded for our perseverance and complete due diligence.

The unfolding NWBO saga still holds for me, all the hallmarks of numerous best selling non fiction from numerous perspectives.

Thank you Longfellow95 for sharing!

DIFFERENT STROKES FOR DIFFERENT FOLKS