If you watch Dr. Hoos’ video from December 2014, and watch it very closely, it appears he wishes to install a new model into trial designs for the future, but to do so, there must be trailblazing trials with antiquated endpoints running out their trials to the longer endpoints to create a data bank of knowledge sufficient to convince regulators one and/or two year looks at 100% of patients will suffice to demonstrate multiple year plateau projections.
If, and I don’t know if they did, but if NWBO decided to take part as a company helping to build that data base in order to shorten future immunotherapeutic trials, it has resulted in NWBO extending its trial to extraordinary lengths. By August, it will be at 51 months since median enrollment and 36 months beyond last patient diagnosis in over a ten year trial. After analysis, there would still be an extra two or three months blinded data to utilize, (taking the blinded post hoc analysis all the way to 36 months past last patient enrolled in a decade plus trial.) If Dr. Hoos considers NWBO’s efforts with data bank enrichment sufficient for his new model, one would assume the scientific advisory board would not continue beyond August for prelock collection. (Again already knowing after lock and analysis they will have yet another two or three months blinded data to add post hoc for data bank posterity, if you will. Above and beyond the call of duty for a tiny little biotech.
Clearly, when LP discussed the tail in January, and again in April of 2018, she spoke of the slope and tail distinct and separate potential performance in the same way as Dr. Hoos did in December 2014’s video. It’s inconceivable to me, but maybe I’m wrong here, that Dr. Hoos, the greater scientific community at large (the consortium he mentioned), or NWBO themselves are hell bent on padding the data enrichment bank to even further extremes unprecedented for future immunotherapy trials. Still, it concerns me, due to the seeming unending voyage we continue to traverse. Good luck to patients, caregivers and longs.
Respect Risk. Conduct Your Own Due Diligence. Manage your assets wisely. Diversify.
