RE:RE:Dr. Jean-Pierre Bizzari
The real question is whether Bizzari has the capacity to provide his statistical prowness to a small population clinical trial involved in the treatment of a orphan/rare disease.
Unlike traditional clinical trials, the inherent difficulty in powering orphan/rare disease clinical trials exist because of small population size, a limited understanding of disease natural history, disease heterogeneity, and challenges with identifying and recruiting participants, that are patently different from traditional clinical trials, which Bizzari might be more familiar with.
Perhaps Bizzari was appointed to ONCY's Scientific Advisory Board so that he could communicate any perceived powering challenges and differences between small population and traditional clinical trials to the FDA, thus expediting the way for pelareorep's FDA Accelerated Approval for the treatment of first line (1L) advanced or metastatic pancreatic cancer.