NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

Poor Man -,

Back when Dr. Linda Liau said that apparently all patients are living longer in October of 2015 she also stated something like “there should be a way to validate this” the assumption being doing so without running another trial. It took 7 years to get ECA guidance changes made so that language could be included that allowed regulators to accept carefully constructed ECAs (essentially case by case) that do not have patient level data for approval consideration. Without these changes a much more rigid set of parameters would have been left in place and given cover for status quo ideologue influenced voting to occur which would have reduced NWBO’s chances for approval whether through outside influence of the vote or just hardliners stuck in the past.
The patent office has also reversed course on claims denials by them when Linda and others submitted additional reasons for why certain claims ought to be allowed. That can only come from becoming more specific than they originally wanted to be about those claims due to the desire to keep their tech claims and rational for use as opaque as possible to protect it from copycats.
More recently the issue of product release in the EU and specifically in the UK on a batch by batch basis has been a big bottleneck issue. I believe that NWBO was encouraged to update their tech to demonstrate the ability to manufacture product to the point that exceptions could be claimed in that process through digitization and other to reduce the QP workload significantly from 30 hours per batch down to much less, perhaps in stages so as not to interrupt the approval process any more than necessary. I also believe multiple regulators have been in talks about this to create unanimity within the next year or two. This makes sense from a regulator standpoint wanting to take into consideration various types of cell based therapy and component release standards while also realizing that they must change some of their standards in order to accommodate mass production techniques and digital oversight that have been or are being created for expected grand scale patient demand. Best wishes.