Reproducibility. A topic I will blog about in an upcoming post, Moffitt reproduced the outcome of Craig's prior work that first pointed to PV-10 inducing systemic effects (anti-tumor immunologic processes stimulated by PV-10 chemoablation).
Accelerated approval for metastatic melanoma. The full scope of Moffitt's work (completed, in-process and in the near future) makes AA a real possibility. Recall Craig's quote in the company's January PR: "...and whether emerging results from ongoing immunologic mechanism of action studies can be used to support accelerated approval in the U.S."
A systemic treatment. Moffitt's work also buttresses PV-10 as a systemic treatment and, thus, the company's significant valuation hurdle figure.
Questions, questions, questions. More answers now create more questions.
- Moffitt's poster at SSO dealt with metastatic melanoma. Did (Has) Moffitt do (done) work on other indications? If so, what were these other indications: HCC/liver, pancreas, breast, colorectal, etc.?
- When will immunology-related human trials commence (the previously termed Phase 2b trial, I believe)? Q2? Later?