NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Let’s pretend some hacks, let’s say their initials are LC and EX, want to make a biosimilar of an ATMP cell therapy like DCVax-l.

1. Could they just try to copy it and get a marketing license?
Answer: Not for about a decade after approval due to biosimilar restrictions

They do not have to wait a decade if they want to take their version through all trials.

2. Could they just use a similar manufacturing process?
Answer: Not for about 20 years after the original patent filing date.

What patent do you claim applies to the existing P3 that did not originate i 2003 or so?

3. Could they make some other product and take it through i, ii and phase iii trials?
Answer: Sure, be my guest. However, if it’s a dendritic therapy, they can’t use DCVax trial data to shortcut their safety claims or efficacy claims for several years.

With a clear roadmap and billions they could get through P1 in a year and go straight to pivotal trials. They can get plenty of safety data by sheer numbers. And the only long term efficacy NWBO is a single indication. If you want to say that GBM is the entire then you have a valid point But if it is all solid tumors, BP could easily be ahead of NWBO,

The real question is why has BP not started such trials when they have (supposedly) know for years how good DCVax