Replies to post #49277 on NorthWest Biotherapeutics Inc (NWBO)

[DoGood_DoWell]

# 1 should not be an issue, because the K score represented by patients will be randomized to both groups, and therefore, if survival of placebo group is longer and the treatment group is longer, what is being measured is the difference between them. The factors that will garner added months will apply to both groups.

same for #2 - as mPFS should reflect this in both groups and if the treatment works, the difference will be attributed to the vaccine.

#3 should be relatively easy to understand as there are historical figures on survival of younger healthier patients after progression. What will be new information, is to see how the vaccine works in people after they have already progressed and how much added survival is achieved.

[iwasadiver]

A couple of things regarding your post:

1. You say: 1. The study is only accepting patients with KPS of 70 or above. Historically available information about survival of GBM don't show anything about how patients in this population survive, but one can assume that they survive longer than the typically published mPFS.

This is not true. See; http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3037140/#i1552-5775-12-4-45-b15
KPS score of >70 is associated with intermediate risk. This has been studied a lot in fact. Bad assumption I feel.

2. You then say: 4. We simply don't know the ages of the people recruited into the study, or how they were randomized into different groups. While GBM usually occurs mostly in older patients, a younger group in this study would result in longer mPFS since age has been shown to be inversely related to survival. Any imbalance in how patients are randomized between the two arms would further change this effect.

The point of randomization is precisely that; creating randomness. The trial took people between the ages of 18 and 70. The trial protocols are looked at by the FDA and I highly doubt they'd find a way to stack the deck in some way regarding age. I'm not sure I understand why you mention this.