More than just the impact of the results or the outcome of the work, which appear to be sublime, what are the takeaways?
- Independently confirmed (demonstrated the reproducibility of) the local and systemic effects (benefits) of PV-10, although the primary focus of the work was the drug's systemic (bystander) effect;
- Identified quintessential immune-mediated response: Splenocytes from PV-10 treated mice produced interferon-γ in response to B16-F10 melanoma cells (p<0.05); and,
- As important as reproducing Craig et al.'s work, demonstrated the veracity of the founders' initial work. Moffitt's work, to me, [continue to] show that Craig, Tim and Eric are accurate and honest. What they say is what we get.
We have yet to find know if Moffitt has [successfully]:
- Demonstrated multi-indication viability. That is, has Moffitt successfully repeated their approach and shown comparable systemic effects using other cancers besides metastatic melanoma?
- Elucidated the breadth and depth, so to speak, of the immune-mediated response and systemic effect?
- A very nice story for some medical academicians and clinicians to better understand, more comfortably grasp onto and/or more heartily embrace the first-line, widespread and pervasive use of PV-10;
- A very nice marketing prop for some big pharma executives to communicate the value proposition and value of the first-line, widespread and pervasive use of PV-10; and,
- Provides internal justification for the FDA to grant accelerated approval for the use of PV-10 to treat metastatic melanoma.