Avid Bioservices Inc (CDMO)

[newbieee]

...but despite a butt load of funding, numerous PR about "breakthroughs" and near earth shattering supposed "biomarker discoveries" etc...LITTLE has actually translated yet into any meaningful new cancer treatments and/or FDA approved products.

It seems like a lot of the information that you post here is inaccurate.

Data Supporting FDA Accelerated Approval in Advanced NSCLC

The accelerated FDA approval was based on a multicenter, open-label multi-cohort, activity-estimating study (KEYNOTE-001), which evaluated KEYTRUDA in a cohort of 280 patients with metastatic NSCLC that had progressed following platinum-containing chemotherapy, and if appropriate, targeted therapy for EGFR (epidermal growth factor receptor) or ALK (anaplastic lymphoma kinase) mutations and any evidence of PD-L1 expression by a clinical trial immunohistochemistry assay. A prospectively defined subgroup was retrospectively analyzed to evaluate PD-L1 as a biomarker among 61 patients with a PD-L1 TPS greater than or equal to 50 percent...

Approval of PD-L1 Companion Diagnostic for Patients with Advanced NSCLC

In parallel with the approval of KEYTRUDA, the FDA has also given Pre-Market Approval (PMA) to the first predictive companion diagnostic for use in detecting PD-L1, an immune-related biomarker expressed on some tumor cells: the PD-L1 IHC 22C3 pharmDx kit made by Dako North America, Inc., an Agilent Technologies Company. The data supporting the approval of KEYTRUDA for metastatic NSCLC showed that 22 percent of patients (n=61/280) had a PD-L1 TPS greater than or equal to 50 percent...