NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

Sure biosectinvestor, you said the same thing a couple years ago, (without providing any evidence) that the comparability studies were previously done. And yet, the most recent confirmation (in January) that the PBMCs are not frozen, was by Dr. Toms, when he stated at the Lifespan WPRI news conference, that the tumor lysate could be shipped from the US, but the leukapheresis procedure would have to be performed in the UK. This would be consistent with using fresh, not frozen, leukapheresis material, as Northwest Bio has always done. If the comparability studies had already been done, and the monocytes were frozen, then it wouldn’t be necessary to perform the leukapheresis in the UK, they could be shipped from the US, just like the tumor tissue.

I’ve stated multiple times that the logistics for cell therapy products are considered a part of the manufacturing process, and will be a part of the marketing application, so of course this has been discussed with regulators. For marketing approval in the UK, performing the leukapheresis locally and using fresh monocytes is perfectly acceptable. However, to ship in commercial volumes globally, the leukapheresis material will absolutely need to be frozen. This is why I raised the issue years ago, not because I think it’s some insurmountable task; it’s not, the procedures are well established. Both Kite and Novartis conducted comparability studies on frozen leukapheresis material well before CAR-T's commercialization. There certainly has been sufficient time for Advent to conduct the comparability studies, but Northwest Bio has been rather elusive on the details about this for some reason, which is curious.