NorthWest Biotherapeutics Inc (NWBO)

[Doktornolittle]

Revised: "Not sure if you are saying mfg is the cause of the hold, but, I do not think so. And, if not, what is the relevance of this discussion? I really appreciate the majority of what is posted on this board. But, I have to say I am just not following the logic of the mfg patent stuff as patents do not typically play a role in this area and certainly do not play a role in timing of use of processes, FDA approvals do, and, FDA approvals do not interfere with patents either, they are separate processes unto themselves with the FDA approval the more important of the two as mfg patents tend to be relatively easy to circumvent, which is why it is not a prevalent practice, though in biologic processing there are more due to the relative newness of the technology, which is starting to become much more widely understood and used."

Oops, hit "update message". Below will be my response in a couple minutes.
My response to a question not posed to me, but I have no manners.

I may not be understanding you, but it seems to me that if regulatory approval of a phase 3 depends in part on demonstrated ability to handle the mfg volume required if the drug becomes part of SOC, then any mfg process that is important to the ability to handle such volume would be relevant for approval. If so, then the patent for that process would matter. If the FDA et al are going to concern themselves with the practical, ultimate realities involving mfg volume, then a related patent would have to be part of that reality. Easy to circumvent? I don't know, but the attitude that the FDA reportedly takes with this kind of issue would not seem to be so relaxed that they would allow the assumption that you would find a way around any patent blocks.

That said, they reportedly already had the patent in question for the US. So it gets mysterious for other reasons than I think you are pointing at in your post.