NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

exwannabe,

My memory generally serves pretty well and I seem to remember Dr. Linda Liau saying something along the lines of "there should be a way to approval" if not those exact words when I watched that video. At the time I remember hearing this I had the impression that this suggestion was in the form of a mild lament which would be more in keeping with your sentiments about this situation. I do not believe Dr. Linda Liau was saying FDA should just approve DCVax-L outright. She seemed to be inferring that regulators, UCLA and NWBO should be able to find a legitimate path to validate the actual type of benefit DCVax-L imparts with a time saving method and that this should provide a way that leads to eventual approval if and when the trial meets or beats it's endpoint(s) goals.

The other related lament I remember was about the crossover coupled with everyone living longer so that the trial itself was not being helped. I considered this observation to have been made for the most obvious of reasons. You can't reach your endpoints on a timely basis to get the treatment approved and to more patients sooner if everyone is living longer. Even if NWBO is sure that L works they can't in all practicality end early due to concerns about reimbursement rates, potential competition and the need for data separation between arms in a long tail. Those are really good reasons why all patients living longer won't help a trial with just PFS and OS endpoints even if it does help trial patients. I believe Dr. Linda Liau also inferred this phenomenon would necessarily guide future trial design for any product that has the potential to greatly extend life for a good portion of patients when she talked about lessons learned. Best wishes.