Avid Bioservices Inc (CDMO)

[2ndstr2thert]

If this is classic data mining why was it necessary to pre specify this with the FDA ?

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 (B2GP1). Data presented at ESMO demonstrated that patients with pre-treatment B2GP1 levels between 200 and 240 (representing approximately 30% of randomized patients) achieved a statistically significant, 5.5-month improvement (13.2 months vs. 7.7 months) in median overall survival (OS) as compared to patients in the control group with the same range of B2GP1 levels [p = 0.049; hazard ratio (HR) = 0.67].”

Looks to me that the FDA GAVE THEM PERMISSION to "data mine" for bio markers ( one of which was B2GP1 } - WHY WOULD THEY DO THAT if not to further an approval process for the Sunrise trial ?