What Peter actually meant to convey was the data the company had long sought in its quest for accelerated approval ("AA"), validated proof of PV-10's systemic benefit, had been generated and shown by Moffitt. Provectus has routinely and regularly asked the FDA for AA. You will recall the MM Phase 2 trial was designed with the goal of getting AA. Since, I think, 2010, the goal has been to meet the threshold of producing evidence of PV-10's systemic benefit in order to attain AA. At AACR in early-April, Moffitt validated PV-10's systemic benefit. Their murine studies confirmed PV-10 chemoablation resulted in both a direct effect on injected lesions as well as a systemic response that led to regression of uninjected subcutaneous and lung lesions. Systemic benefit has been and was shown [to the FDA]. Game over.
What does Peter mean when he says Eric and his team are focused on getting PV-10 approved? I think he means to convey Eric et al. are working collaboratively with the FDA to provide what additional information is required by the agency, if any, to get the drug approved. I don't think this is about SPA or BTD applications or submissions, or their timing, anymore. I think it's now just about getting PV-10 approved.