NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

exwannabe, do we really have to recycle this false narrative again? The fact that you continue to repeat it, leads me to believe that perhaps you may not actually understand cell therapy.

Yes, living cells are complex, so in order to receive regulatory approval, a cell therapy program is required to determine the critical quality attributes (CQAs) of their cells, or the characteristics which define their product (characterization), and to develop analytic testing methods (assays) to analyze each batch for potency, purity, sterility, viability, and stability. This is essential for quality control, GMP product release, and yes for comparability testing of the Flaskworks’ system. UCLA would likely have developed some of the assays to test DCVax for safety and identity in preclinical and phase I trials, and then further characterization and assay development was done by Cognate, Fraunhofer, and more recently by Shashi Murthy. DCVax was fully characterized, and the required assays developed, optimized, qualified, and validated many years ago. As I said to you the last time you perpetrated this false narrative, this is how Linda Liau and other UCLA researchers can say that the ATL-DC vaccine that UCLA is using in the combination trial with Keytruda for rGBM, is basically the same vaccine as DCVax-L.