when Provectus held an end-of-Phase 2 meeting with the FDA regarding PV-10's regulatory pathway for metastatic melanoma, PV-10's efficacy has increased, the drug still maintains a pristine safety and adverse event profile, PV-10's mechanism of action is understood, and there now is proof of the drug's systemic properties and benefits.
The company had designed its MM Phase 2 trial in hopes of securing accelerated approval. I have no doubt management knew, following the April EOP2 meeting, that it had to provide proof of PV-10's systemic properties and demonstrate the drug's systemic benefit. Even though Provectus' goal was to seek accelerated approval for PV-10 as a local-regional drug for Stage 3 melanoma patients.
As early as March 2010, the company began describing the involvement of the immune system in response to PV-10 therapy and its role in the bystander effect. Later, at ASCO 2010, Provectus provided data on visceral metastases.
The FDA may have told the company to explain PV-10's MOA and provide proof of system properties and benefits in order to get AA. Rather than seek a regular MM Phase 3 trial, and in addition to seeking an SPA for this trial, management sought to answer the FDA's queries in hopes of eventually achieving AA.
Moffitt has explained PV-10's MOA, and provided proof of the drug's systemic properties and systemic benefit.
So, information was requested, and it's likely been or shortly will be delivered. Now, it's simply up to the FDA to decide. Notwithstanding what the FDA decides, there really is no bad outcome to me.
An SPA is terrific. A breakthrough therapy designation (some truncated trial or shorter path) is fantastic. AA is mind blowing.
Good, better, best.
The closer you are to the company, the greater your awareness is of Provectus' situation, the higher expectations or anticipation you have of an SPA, BTD or AA. The less familiar you are with the company or situation, the lower your level of expectations are. The FDA's decision will validate Provectus and PV-10 in some form and fashion.
From here, the first day of the next phase for Provectus begins in ernest.