Replies to post #57471 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

This all started back in August 2015, and the 1st interim analysis had not occurred by May 10th, 2015, and it may not have occurred until after August, or even after October. The FDA wants reliability.

NW stated the goings on back then were part of the trial protocol, and nothing untoward was occurring.

If this relates to changes for imaging procedures and analysis of images, that would not have happened in a vacuum. The resizing occurred in 2014. The new protocol may have anticipated changes in imaging standards, and the FDA would have been a part of conducting that eventual midtrial change.

[Rkmatters]

Because iRANO does not account for how "effective" immunotherapy changes neuro-oncology radiographic scans and may affect how they determine progression events. Experts in the field sought to change it while this trial is on-going, and so this trial should adapt to it. All immunotherapy trials should. Old methods may mean they call a non-progression event a PFS one, hence the need to change it. Folks should pay for the article I referenced if they don't understand. It is something to do with trial design not true efficacy per say. Patients OS, if the treatment is effective, would end up being very strong. It's an immunotherapy trial that has a crossover so it does deal with PFS events (even early ones) that are not true progression. Only issue is placebo arm patients get the vaccine as well at crossover too. Their PFS events with iRANO may end up being later than the vaccine if enough treatment arm patients are mostly responsive to vaccine and are prematurely removed. However, the placebo patients timing of their vaccine is still much later, so that is bound to affect efficacy for those patients. Time will tell.

[Rkmatters]

By the way, my opinion all along is that PFS was going to be close. I believed the vaccine was getting all the credit that were do to some of the other variables those prior treatment patients had (extent of surgery). The 15 month PFS was not all vaccine. Some of it was changes to standard of care that UCLA was privy to first (iMRI in 2005). But at some point those advantages expire (surgery and chemo only extends survival so much) and the patients lived longer than new norms, so the vaccine possibly contributed to a greater percentage to long-tail OS. This trial is to test how much of a difference it's making. My hope is that it's significant.