NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

Doc Logic,

Thank you!
Perhaps this is an interesting reading.

Guidance for Industry
" Potency Tests for Cellular and Gene Therapy Products."

I. INTRODUCTION

We, FDA, are issuing this guidance to provide you, manufacturers of cellular and gene therapy (CGT) products, with recommendations for developing tests to measure potency. These recommendations are intended to clarify the potency information that could support an Investigational New Drug Application3 (IND) or a Biologics License Application (BLA).

https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/UCM243392.pdf