Replies to post #274364 on Avid Bioservices Inc (CDMO)

[Protector]

stoneroad, that is not how this works.

With that being the case it is POSSIBLE that the Biomarker has identified a subset of the population where Bavi is more efficacious.

The biomarkers as such do not identify ANYTHING at first. PPHM must FIRST use the traditional means of measuring progression/regression (such as RECIST with tumours) and establish a RESULT OF THE TRAIL. In this case the measuring is overall survival according the PR, hence the median tables.

Then, AND ONLY THEN, when they have a CONCLUSIVE situation in this case saying that they have establish statistical significant overall survival improvement (Sunrise's 1st end-point) THEN they can check if they would have come to a SAME PREDICTIVE outcome conclusion with biomarkers.

Actually they GO BACK IN TIME (because they have the blood samples from the COMPLETE TRIAL DURATION) and look at the biomarkers. Next they see if they can say something like:

IF you see biomarker X present at at least levels of Y then the patient will be in the group that profits from said overall survival. If however the biomarker is not present or insufficiently present, etc, then that patient would better be steered to another treatment because Bavi+Doce will not work for him.

I have put it in black and white but the decision scale may be, and actually is, more subtle and expresses expected levels at certain points in time during the treatment, etc. I think however that the above illustrates that in what PPHM PRed it are NOT the biomarkers that identified the stat. sig. overall survival group but that the biomarkers were checked to see if they could be correlated to the results obtained by traditional measuring.

You can see the value of this. If PPHM has an established biomarker for bavituximab response then they can in a clinical trial not have to wait for 24 or 36 months to find out how the treatment will work out for the patient but do bloodwork in week 2,4,8, etc and then check the biomarkers and say it will or will not work for this patient. A chance % may be added (as in 70 or 90% etc).

The commercial value is in early patient redirection of treatment or even patients selection as in the PD-L1 positive testing.