Avid Bioservices Inc (CDMO)

[exwannabe]

eb0703, that was me that started the "biomarker positve subgroup" talk.

True, the biomarker could be continuous (i.e., % expression or some such), but most of the biomarkers in this space recently have tended to be binary (a patient has it or not).

If the marker is binary, it by definition would divide the trial into those that are positive and those negative. And the positive group would be what you hope shows the stat improvement with Bavi+Doce over Doce.

Anyway. I am leaning back to more my orriginal reading.

Presented data will include a biomarker in the SUNRISE trial that correlated with a statistically significant improvement in overall survival for patients treated with bavituximab in combination with docetaxel compared to patients treated with docetaxel alone.

I.E., what was stat sig is that those with the biomarker live longer. And what does that mean for Bavi? Very little w/o further data.

Suppose for example what they show is that those with more TILs live longer? Does that mean Bavi works? No, It simply means that those who have more TILs do better.

Suppose we know that Bavi increases TIL cell count also? Can you combine the two to assume Bavi works? No again. It might be a reasonable hypothis, but needs to be shown

At best one has a theory to work with.