Gary, That may be the practical pathway for now, to have poly-iclc (adjuvant) be enrolled in right-to-try and compassionate use programs and for oncologists to submit request to the FDA / MHRA to use it for the cancer patient they are treating. It would be a paperwork burden, and more so a burden for some oncologists that don't normally submit such things to the FDA / MHRA.
Possibly the NWBO "Franchise" includes offering support in these areas and more broadly, as a benefit to being a Franchisee. Given the personalized nature of DCVax-L and the complexity and heterogeneity of cancers, the following data and support could be important for the oncologist in forming an optimized DCVax + adjuvant therapy for a patient:
- genomic sequencing (ie the 100,000 Genomes Project, Dr. Ashkan on whole genome sequencing of 403 glioma tumors)
- proteomics on tumor lysate (ie which adjuvants work best in each situation, Dr. Bosch, June 2023)
- immune profiling from blood/tumor lysate (ie analyze the tumor microenvironment and immune system to predict best adjuvants)
- help with compassionate use applications for adjuvants like poly-ICLC (ie streamline process, making the case for use)
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