Yes, there was. But even she said that criteria other than those related to chemo/rad type endpoints should be used for immunological approaches. She also said that all patients are living longer which may be good for the patients but not so much for our trial in lessons learned. Of course, she thinks DC VAX is efficacious and has said that a way should be found to approve it, or words to that effect.
Accordingly, she shares LP's view that the regulatory pathway is not clear and a new one should be "pioneered". However, this is an admission that the endpoints may not be met. In which case a convincing marker should be used. Thus, the long tail. The idea being that current SOC (resection- chemo/rad) treats the front end and the adjuvant DC VAX treats the back end(long tail) for a new SOC paradigm. Thus, the emphasis on a long tail home-run to confirm DC VAX's value in the new SOC paradigm. Essentially, PFS as a surrogate is not highly relevant here. Neither is mOS or even overall OS. If the long tail sufficiently covers a significant spectrum of glial cancers which are highly heterogeneous and gives hope for 1 in 3 to be alive after 36 months and 1 out of 5 to be alive after 60 months as opposed to 1 in 20, then the therapy should be approved. If the numbers are even better, that increases odds of approval. That's the pathway being pursued by NWBO, and it wants the numbers to be undeniable just in case the primary/secondary end points are not. However, it is not the usual pathway and thus a different pathway more attuned to immunological approaches is being pioneered. That is why it is a good reason to continue the trial while appeasing anxious shareholders with a data-lock statement devoid of a date in order to buy more time. We are not yet at the end. Hopefully, it will be in 2019. Stay tuned.
