NorthWest Biotherapeutics Inc (NWBO)

[doingmybest]

Lykiri,

Like a lot of issues discussed here it is quite difficult to be definitive with such partial knowledge of the facts. However the principles of how to prove similarity apply to all types of products. The mfgr has to ensure through science and testing that safety, efficacy, purity and quality are not negatively affected. You may already know this. We know they have introduced TFF into the mfg process. TFF is mostly an efficiency improvement but it can, like all changes have additional desired or not desired effects. In this application it is probable that it is a significant efficiency improvement due to the difficulty in attaining the appropriate type of DC's. We know they hired the German technology group to optimize the mfg process. We don't know what all was changed here. My guess is that the majority of work was focused on process definition and not changes per se. This means the work was focused on defining the appropriate ranges for each critical process parameter through testing. This work is typically started prior to P3 but often mostly done concurrent with P3 clinical trial activity due to mfg preparedness activity. I'm not aware of any major differences introduced to their processing technology. I don't see anything of concern here. It is always good to have guidance from RA's to provide structure to technical tasks and to technical discussions with them. There is no reason not to believe their technical people at Cognate and elsewhere that they employed are not expert at honing this process and that their regulatory people are not expert at knowing how to manage the info to the RA's inside and outside of clinical activity.