I tried to piece together the history, as much as I understand it, of the time taken to pursue the SPA.
The company's October 2, 2012 PR elucidates the progression definition and programmatic element work that comprise some of the time taken.
Progression definition work. "Progression Free Survival (PFS) will serve as the primary endpoint, with progression defined to include increased tumor burden, advent of active nodal disease, onset of distant metastasis and symptomatic deterioration based on validated instruments."
Programmatic element work. "We have also completed detailed operational planning, something which the FDA now frequently expects as part of the SPA package and a critical step to assure that the study runs smoothly."
The systemic benefit validation, provided by both Moffitt and Provectus' PRs, does not relate to the process of finalizing the SPA with the FDA, although it coincides with the timing of when SPA should be finalized. Of greater interest, and the topic of a subsequent post, that same systemic benefit understanding provides the springboard to a breakthrough therapy designation (accelerated approval) this year.