NorthWest Biotherapeutics Inc (NWBO)

[Doktornolittle]

It may seem ridiculous to say that the FDA should bear some of the responsibility if the available measures for PFS prove flawed for the immunotherapies. However, consider that according to Lind Liau, the FDA insisted on crossover of the control arm upon progression in the DCVax-L trial.

Maybe Linda Liau misspoke, but I must consider the likelihood that she was accurate. If so, you have to ask, why would the FDA insist on this? The only explanation I remember hearing posed was that the FDA recognized DCVax-L to be so effective that it would be inhumane to not provide it to the patients that progress in the control group. But that is ridiculous. There is no way that the FDA would do that. So what happened? To be honest, either LL misspoke, or this was an attempt at subterfuge by the FDA, which given the Moonshot environment, and the background of the man in charge of it, ... the FDA better try to fix this or somebody is going to hang.