Are We There Yet?

Why is it taking so long to lock and thus release the MM Phase 2 and psoriasis Phase 2c data?

For the psoriasis trial, patient accrual ended in May 2011 (with 4 and 8 week measurement periods for primary and secondary outcome measures). Some, but not all, data of the MM Phase 2 trial was released in November 2010. While I think this data will be locked in March, relegating further worry as unproductive, I wondered what took so long. Was there something wrong with the data? Was management slow?

It recently dawned on me to examine a hypothesis: Management took what time was necessary to get it right? -- What is "it"? What does "right" mean?

It: Provectus' clinical value proposition: In the near-term, a robust safety profile and, initially, a very focused label indication of loco-regional application. Over the long-term, a much broader "label" of systemic application. Set aside safety, but recall the magic, statistically-oriented number of 300, which was important in the company's discussions with the TGA in gaining marketing approval: interim data from the Phase 3 trial (how many patients need to be enrolled, treated and evaluated?) + data from prior trials and programs (n = 20 from MM P1, n = 80 from MM P2, n = 6 from breast P1, n = 6 from HCC P1, n = 60-70 from CC program).

Right: Showing statistically significant clinical reproducibility and repeatability in and across indications, and [very, very carefully, but yet at the same time "statistically significantly"] contrast and compare efficacy. Again, set aside safety (recall that Rose Bengal has already been approved by the FDA and has a large safety dossier already on file with the agency to which Provectus has been adding to over time for both oncology and dermatology).

I contend management, given their focus on repeatability and reproducibility, is pursuing statistical significance with a narrow standard deviation on a smaller but the statistically required number of patients (an intelligent and capital efficient manner of conducting trials), rather than big pharma's capital insensitive approach of large numbers of trials of large numbers of patients. As a result, there is much more heightened sense of focus by management (Eric, in particular, as the lead among them for the clinical trials) on accumulating, tabulating, analyzing and presenting the data, and thus getting it right.