Replies to post #233286 on NorthWest Biotherapeutics Inc (NWBO)

[Extremist223]

She later goes on to say that minimal residual disease is probably better to skate by checkpoint inhibition, which could allow the early dcvax vs late dcvax to show statistical separation.

[longfellow95]

Ermm. Not exactly what you would want in an RCT, it has to be said.

[exwannabe]

LL has been saying that the trial is now "early vs late" for 3-1/2 years.

But early vs late only applies to OS not the pre-defined primary endpoint of PFS.

That is one reason why many think the primary endpoint is no longer in play. Pick a reason:

. futility
. psPD masks the true PFS data
. the dog ate the scans

Reason does not matter. There are so many indications the designed primary PFS endpoint can not longer be established that it is difficult to accept any other explanation.

[meirluc]

Woahhhh.... 28:00 minutes in-
LL- “the majority of patients actually did get the vaccine at some point, umm so the, so this actually probably turned, is going to turn out to be a very large single arm study that has a variable where some patients got the vaccine early and some patients got the vaccine late”

Could that mean that LL considering the possibility that the two arms may not show a SS separation and NWBO may have to prove efficacy for DCVax-L in a novel manner. Perhaps both arms will demonstrate an unusual number of post 36 months survivor. However, if both arms demonstrate a non proportional hazard pattern with for example an unusually rapid post 30 months decrease in rates of attrition never seen before, NWBO may have a path to approval.

OTOH 33 of the 99 placebo/controls did not receive DCVax-L at any time and their mOS may still bring the mOS of the entire group of 99 placebo/controls to a level which is SS lower than the mOS of the 232 patient Trial arm.