March 20, 2013
Some $PVCT Regulatory Pathway FAQs
What is the status of the Special Protocol Assessment (“SPA”)? The Company continues to work with the FDA to obtain the SPA for the pivotal MM Phase 3 study.
Have the trial parameters for the SPA been finalized? Yes, as far as we know prior to receiving the SPA.
Why has the SPA process taken so long? The SPA process is very detailed, and has taken time to complete.
Is mechanism of action (“MOA”) – Moffitt’s work to definitively show PV-10 systemic benefit – necessary for the SPA process? No. The pivotal MM Phase 3 trial design permits all melanoma to be treated. Nothing is left untreated, so systemic benefit is not relevant.
Is MOA necessary for accelerated approval (“AA”) and breakthrough therapy designation (“BTD”)? Yes, with MOA meaning proof of systemic benefit in the case of PV-10. The FDA has always wanted proof of PV-10’s systemic benefit.
How does seeking BTD affect the SPA? It does not. Provectus will continue to work with the FDA on the SPA, and also will submit a request for BTD for PV-10.
If the company receives BTD for PV-10, what are the implications? Provectus may (i) obtain the SPA quicker (if not received prior to BTD), (ii) achieve AA or (iii) have no requirement to complete a Phase 3 trial.