Replies to post #63295 on NorthWest Biotherapeutics Inc (NWBO)

[Rkmatters]

I'm not saying manufacturing is the cause of the hold. I'm saying they need regulators okay to enroll patients to a new patented manufacturing method. But the new method is technically on a clinical hold in Germany. And the new UK site to handle delivery may not be fully cleared by regulators yet. I imagine they are close.

As for me answering his other points in the posts, that was done to substatiate NW Bio's statements in which they stated that one of the biggest reasons cellular products are put on clinical hold during either clinical or product development is due to manufacturing. In their case they need to qualify their new manufacturing process, so it is considered product improvement not an error. I sincerely doubt that Frauhoper ran into any issue. But they are changing the delivery supplier so there is a chance that the service they use to deliver product around Europe. I doubt that is the case, as I believe they would have been legally obligated to disclose to us within 3 days. Since they did not, I'm assuming no issue.

[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.