NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Re: What happens if 88th event occurs before the minimal event number in the pseudo-progression group?


First, I think it is important to say this is unlikely. From my simple mathmatical analysis, they need 19 events from the group of 72. The pseudoprogression group (19 event accumulation) still has at least an 18 month jump on the additional 22 events that must ultimately come from the primary group. Even though all or almost almost everyone from the pseudoprogression group will be a responder 1st to chemoradiation then more so to DCVAX-L if they are in the treatment group, the chance for the primary group to fly by the pseudoprogression group in event tallies is unlikely.


Anyway, if it does happen, I think it would be best to chart how I think the DMC will organize things if the 88th event occurs in the primary group before the (probably 19) events occurs in the pseudoprogression group.

1. The DMC already analyzed the 66 events by themselves.
2. The DMC would analyze the 88 events by themselves.
3. The DMC would then get the 19 or so pseudoprogression events and analyze them by themselves.
4. Then they would take the 19 or so events and run a statistical analysis either on the 19 plus 66 together, or the 19 +88 together. I'm not certain which, because I'm not certain if they are trying to mimic the likely percentage one might see in a random global population or not.

That last part gets to a level of detail that I think only the statisticians can wrap their brains around, but the preplanned response to this unlikely scenario, should it occur, was likely already worked out by the FDA and NWBO on or before May 17, 2012.