February 10, 2013
$PVCT: Waiting for MoffittCancerCenter (@MoffittNews)
I previously wrote that: I asked Pete for his perspective on it in the context of management's work with the FDA. Regulatory approval is a complex topic, especially as it relates to local agent PV-10 versus systemic ones. PV-10 as a local agent is a reality that has driven management's MM Phase 3 trial design more than anything else. The key to the FDA, according to Peter, is proving "clinical relevance." This certainly means meeting endpoints, but it also means whether a drug should be approved or not. PV-10 needs to be clinically relevant to be approved. Provectus' Phase 3 trial design discussed with the FDA would support PV-10 as being "clinically relevant."
With two days left, the blog's poll -- What company achievement will have the greatest impact on share price in Q1? -- has 13% of participants voting for Moffitt's data. I previously wrote that I don't think Moffitt's full effect will be felt this quarter. That does not mean I think Moffitt is not important. It appears Moffitt is crucial to Provectus, PV-10 and Rose Bengals' story.
Management will not say where, when and what Moffitt will say about the cancer center's follow-up mouse work to SSO (recall here and here), and whether some of Moffitt's human trial work results will be available concurrently with the mouse work.
So, we wait...
Peter says "Everyone, and I mean everyone, wants to better understand the systemic benefit of PV-10." With that, I assume "everyone" includes the FDA. Management's silence on Moffitt's results as well as the timing and venues of their presentation and publication suggest to me the FDA, Big Pharma and serious life sciences investors also have not seen Moffitt's full data-set.
In Provectus' CEO Letter last April, management discussed how Moffitt's work was "...fundamental for full characterization of PV-10's systemic benefit and may provide pivotal support for accelerated approval in the U.S." Accelerated approval is a real possibility, given the basis for seeking such is the import of Moffitt's work.
Moffitt weighing in on PV-10's clinical relevance and the timing of these comments should give us great insight into whether and when the management might state it is appropriate to seek accelerated approval based on discussions with the FDA.