Honestly, I’m not 100% if they did, but I read Reefrad tell Flip he had seen the new protocol. They haven’t updated the NCT inclusion/exclusion criteria. But, the idea came to me last month when Flip asked an lymphocyte inclusion question about the info arm, it made me think about it.
During that post conversation speaking about a HE patient, I became convinced that NW Bio had made a manufacturing change back in 2013 in the U.S. and then pursued that patent in Europe, and the August 2014 change to the trial was related to that.
And of course I was excited about it back then, as the issue of insufficient vaccines would go down. If patients crossed over, even on vaccine they would have enough vaccine to get more than 10 injections. Linda Liau's comments about the study make more sense too.
As it turns out, I believe my assumption was correct, and in 2013, the US started using that patent. Great Britain followed suit in August 2014. But, here is where it gets interesting, in July 17, 2015, German had issue with some of the claims within the TTF patent, and denied it.
Of course, the Company attempts an appeal. Then the study stopped screening new patients. If the patent would have been denied, then that probably would have meant that the trial would be in jeopardy. I would think they hold off recruiting until the end as they want some of German patients to be under this patent. Manufacturing consistencies across the board.
It's a good thing I only stumbled on this today as the shorts would of had a field day. The excellent news is the process is now complete, and within a couple of days we should hear news that all is fine, assuming that is what the screening halt was about. All claims have been satisfied and updated as of Wednesday, May 25, 2016.