Replies to post #93347 on NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

Those people! Living too long! Just who the heck do they think they are anyway!?

[Pyrrhonian]

What do you mean by "evented"? Progressive disease (PD), including only deaths before documented progression (PFS)? Or do you mean PD and all deaths? Cause from what LL said and how she said it, I'm not so sure:

36:00

"...the trial is still blinded until data lock, and data lock will occur when 75% of the patients have an event, meaning um, death, or, you know, progression or death. Um, so so far that hasn't happened um, but, ya know, uh--but it's, it-- so so, --the whole group is doing better, ya know, the treatment and the control group. They seem to be doing better than the historical (deep breath), um.. I guess analysis for this. In a way it's uh, it it's good, it's it's very good for the patients. Um.. but it may not be so good for the trial (laughs), because you.. you kinda, you wanna see a difference between the two groups and the fact that the whole group seems to be doing better--um although we don't know who's who, um.. ya know, that that, uh, that could uh.. be an issue in term of FDA approval.

Um... ... but, um.. but we all do believe that there is uh, ya know efficacy in this, and it's uh it's, really comes down to what, ya know potentially what happened with the uh, EGFR vaccine trial, ya know in terms of the endpoints and and and the trial design, and, and and how to best.. uh.. elucidate the differences here."

Sounded to me like a screw up or two in there. And that's the problem with giving too much weight to what these PIs say off the cuff. It's not an official company release. NWBO doesn't have to defend any of it, and aren't liable if investors invest on any of it and it ends up being totally wrong. There was another PI btw that spoke at a conference not all that long ago, if you recall, and he made lots of mistakes in his talk. NWBO didn't correct it publicly. No need to.

Now when you look at the PR they purposely avoid saying "primary endpoint." They chose "main endpoints," which of course includes OS (all deaths). Even though the Dec 2013 PR was full of "primary endpoint" talk and gave the number of events. Why did NWBO just say 248 PFS events in their recent PR? I think the reason is because it's been hit already. But I guess there's room to reason not. Though imo slim.

Here are my guesses (in order of likelihood):

-248 PFS events reached already, company awaiting 233 deaths; 299 randomized into main arm, 32 psPD into separate arm

-248 PFS events reached already, company awaiting 233 deaths; 331 rand into main arm, 32 in psPD arm.

-248 PFS events not yet reached, company awaiting it, 299 rand into main arm, 32 in psPD arm.

-248 events not yet reached, company awaiting it, 331 rand into main and 32 in psPD arm (I give this last one, which most longs think most likely, only a 5% chance of being factual).

If I haven't said it to you already, hope you do well this year.

Cheers