Tuesday, November 22, 2016 2:28:05 PM
By the way, Linda Liau’s comments were transcribed by Bohsie, who posted them on Seeking Alpha in the comments section of Phase V piece. It's been there this whole time:
“The issue is because we have the vaccine made for everybody and we are kinda doing a somewhat invasive procedure on these patients, the FDA actually required us to have a crossover arm when the patients progress.
So uh interestingly, the whole cohort actually, um, has not reached its pre-determined event, um, how do I say this, pre-determined number of events. Um, it seems like everyone’s living longer than we would be expecting. So in reality, I think, you know, what we’re really comparing now is actually early DC vaccinations versus later DC vaccinations (big smile). And um, and I guess it’s a good thing that the patients are living longer (laughing), but it’s not really helping our study, because if the patients didn’t get anything, hopefully the differences would be bigger. So that’s kind of another lesson learned about these trials. We have to consider all these different moving parts.
Um, it was difficult to, it’s certainly more difficult to enroll a patient without a crossover arm because they are going through an invasive procedure, and then tell them we’re making vaccine for you, but then we’re just throwing it away. You know it would be difficult.
But so anyway, we’re still in the middle of this trial, it’s still blinded, and I actually don’t have any data for you right now” — Linda Liau
Here’s the 2013 protocol O/S assumptions:
15.4.2. Secondary Endpoint #1
Analysis and assumptions for the secondary endpoint (OS) will be similar to those described above, with the following changes. The endpoint will be time to death, and the follow-up time is 9 months. To calculate the power of OS we assume median survival times of 17 and 34 months among patients in the placebo and treatment cohorts, respectively.
I interpreted her comments as the overall cohort patients were living longer than their protocol assumptions. And, by "overall", we know that ALL patients are living longer. And while we don't know by how much, I do think it is safe to assume that the "overall" cohort are not falling short on their built in assumptions for overall survival (17 O/S Placebo; 34 O/S). And I interpreted by her comments that the vaccine is making a difference at crossover for patients.
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