A Bloomberg article earlier in the week discussed "breakthrough status" for drugs to "...have closer communication with top FDA staff to move drugs for serious diseases to market more quickly, potentially with data from an expanded Phase 1 trial." Breakthrough status would be more applicable to Provectus' liver work than the company's melanoma work.
I asked management if Provectus submitted a request for Breakthrough Therapy designation for PV-10. As with the SPA process, it is unlikely the company will publicly discuss submissions for this process. Rather, should management secure this designation for PV-10, the market will read about it via a company PR.