Replies to post #34901 on NorthWest Biotherapeutics Inc (NWBO)

[koman]

IMO I really don't know what criteria for an early halt for efficacy at an IA will require. I'm assuming based on reading other's posts that there is usually a more strict or higher bar to meet for a predefined statistical endpoint. It might mean meeting or exceeding the 4mth PFS advantage w/ a p value < 0.002 (vs the 0.02 that was mentioned by LP) or maybe the higher bar is say 9mth PFS advantage w/ p value < 0.02 at the IA. I don't think most companies give out such detail in a PR and one won't find out until the FDA docs come out on the decision for AA or full approval. But I don't think LP really even mentioned anything like what NLNK and now the latest PR by intercept stated about the actual potential for an IA halt for efficacy. LP's statement was more general so that one cannot conclude that such talks were discussed w/ the FDA to predefine what conditions must be met for early halt for efficacy (if this even needs to be done, but I'm assuming it should be done).

But from my perspective, I'm not in control of this process and I'm pretty sure management will not divulge this information prior to the IA being done. And if the IA meets that predefined criteria for early halt for efficacy AND the co decides to apply for AA while the study continues blinded, I'm almost certain that we will get a PR from the co or else someone will find out that they applied for AA w/ the FDA. IMO if I was in their shoes, I'd PR that fact as loudly as possible and I'd doubt that PR will result in controversy like for OREX. They wouldn't even need to give out any data at that point. So to me this issue is low on my concern radar. It's the belated IA timing and the enrollment that is most important that is IMO holding back this sp. DIRECT is a side issue for now from my perspective and if there were really positive data from it, I'd PR it as loudly as possible as well or else I'd remain as quiet as possible for as long as possible so that stockholders will always be conjecturing on MB on how well it is doing (or not).

[flipper44]

Koman,

I know this topic is not on your priority list, but just to follow through with this possible scenario under the new accelerated approval clause. I think that if the blind is continued after a halt recommendation is publicly announced, that means the halt recommendation was rejected by the company in favor of accelerated approval under that clause, which means, THEY CAN KEEP ENROLLING. When you were speaking in a prior post, you stated after the halt this could occur, but I think what you meant is after the halt recommendation. Regardless, if they can keep enrolling, then they will certainly have full enrollment before long because of the positive press from the halt recommendation announcement -- which I think is what you meant.