February 6, 2013

$PVCT: Clinical Relevance

A reader of the blog led me to the twitter feed below. Thank you.

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 (and which was not specifically addressed in the Twitter feed above), 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." Moffitt's work also would further augment the case for PV-10's clinical relevance.

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