Avid Bioservices Inc (CDMO)

[BioBS2012]

BioBS, can you articulate why you believe the translational data and how it translates to efficacy to be more important than MOS?

If you look at the Nexavar clinical data you will see that depending on the subgroup (based on ECOG or Child-Pugh scales) the mOS varies widely

SHARP Trial (all inclusive) - mOS = 10.7 months
SHARP Trial (subgroup ECOG 1-2) mOS = 8.9 months

AP Trial (subgroup ECOG 1-2) mOS = 6.1 months

GIDEON Study (Clinical setting n=3000)
Subgroup [ Child-Pugh A ] mOS = 13.6
Subgroup [ Child-Pugh B ] mOS = 5.2 months
Subgroup [ Child-Pugh C ] mOS = 2.6 months

So as you can see, depending on which subgroup the patient is in, the historical mOS could be vastly different. I don't know if the # of patients in the Phase II IST is sufficient to allow for stratification / subgroup analysis from a statistical perspective. Also this is a single-arm study so the only comparision that can be made is to historical data. If the data is vastly superior it is not difficult to do that. However in most cases the improvements are incremental and will likely not be large enough to impress everyone - though ofcourse those that are close to the subject will see the data for what it is.
From the recent poster the translational data showed several positive outcomes in my view
1. It further validated BAVI's MOA
2. If you look at the swimmer's plot (horizontal bar chart) - even with this small number of subjects, there seems to be a correlation of TTP to some biomarkers
3. As mojojo and some others have pointed out - the findings about PD-1 - the fact that there could be additional synergies with Anti-PD1 drugs is also a big plus (besides further validating the MOA.

Anyways, enough speculation. Looking forward to see what transpires ahead. My confidence remains high.