Avid Bioservices Inc (CDMO)

[vinmantoo]

Quote:The study protocol pre-specified the collection of thousands of patient samples for exploratory analyses over a wide range of possible biomarkers, including pre-treatment levels of beta-2 glycoprotein-1 (ß2GP1).

From the above, now that I have read it a few times, it is easy to see that what was pre-specified was the "collection of thousands of patient samples for exploratory analyses over a wide range of possible biomarkers"

What PPHM said was essentially we will be examining every possible biomarker we can find, and look for after the trial is over that somehow correlates with better outcome. One of these is B2GP1. It is classic post-doc data mining and cannot be used to seek FDA approval.