NorthWest Biotherapeutics Inc (NWBO)

[koman]

So flipper, are you saying that in your prev posts (and not jsut these last recent ones) that you didn't anticipate a early halt for efficacy as a possibility? IMO I don't think that nWBO should and most likely will never put forth any guidelines about a possible early halt for efficacy as designed in the statistical analysis in a prespecified interim analysis beyond what they have already stated. It is better to be vague in this case to protect themselves. Look at the example of NLNK that someone else brought up. The management were the one who in their latest 10K had brought up the possibility of an early halt for efficacy designed into their 2nd IA

"The Company revised its timing expectations and stated today that it expects to report on the second interim analysis in the first or second quarter of 2015. The possible outcomes for the second interim look include confirmation of continuing the study as designed to the pre-planned endpoint. The alternative outcome is a decision to proceed with filing with the FDA on the basis of the interim data due to improvement in overall survival rate as determined by the early stopping rules in the trial's Special Protocol Assessment."

I don't think that NWBO has such a design in place and they havn't been specific about it. I think the idea of early halt for efficacy came from these MB rather than from LP though she may have mentioned it as a possibility of what can happen in a generalized sense in a trial. Also, if such a halt for efficacy was prespecified in the statistical analysis at the interim and it is met I cannot see why it wouldn't trigger an automatic halt for efficacy RECOMMENDATION at which point LP can still continue the trial to completion for other data maturation as the SP
spikes to 20 or more. So in other words I doubt NWBO will ever be able to give you more color on your latest interesting question on how to interpret a continuance at the FIRST IA for dcvaxl (after the latest changes). You can always try to ask Dr. Bosch in an email, but I'm sure he will decline to answer that as I would also in his position.

NLNK set themselves up for this latest sp fall when their hopes for an early halt for efficacy that THEY had PR'd didn't come thru. Though I won't go as far as AF to say that their pIII trial is "doomed" to fail because he is so negative on all cancer vaccines in general.