Avid Bioservices Inc (CDMO)

[bimerkjaere]

It is not possible to understand the clinical impact of the incorrect 1mg and/or placebo doses. Even if details on how many doses were actually given incorrectly (placebo arm receiving 1mg bavi or vice versa), it is really futile to try discern the clinical impact of such errors.

This is because we do not have a good understanding of bavi's pharmacodynamics to the level of predicting each dose's impact on survival. Let's say we find out that 3 weekly injections were misgiven to each treatment arm (1mg and placebo), we can't attribute a survival impact to each misdose. Meaning, we don't really know how many doses of 1mg or 3mg bavi it takes to achieve 6 mos, 9mos, 12mos, etc.. of survival.

This is likely why pphm is combining the 1mg and placebo arms. They can't believe that they can walk into the FDA and say, "well, the 1mg arm only got 2 weekly injections of placebo, therefore we think the MOS is impacted by 20% (or pick a number)".

I am not saying that the MOS reading for the 1mg arm should be completely discredited, but it should only be used as an indicator and not used in any statistical analysis.