Here's what struck me about the interview:
- I chuckled when I heard the interviewer's comments on the previous guidance from the company on the SPA process. I think the company unofficially secured the SPA (my post on this topic is here). I must not be the only one. The interviewer's phrases were telling, paraphrasing: "Provectus received the blessing of the FDA for the final design" and "the FDA came to a consensus with Provectus on the design."
- The interviewer spoke several times on Rose Bengal's prior approval by and large safety dossier already on file with the FDA. Caig said management specifically chose Rose Bengal because of this long and well documented safety history, but that it was not the only halogenated xanthene in their portfolio.
- Craig's comments about their prior knowledge of the cold-loading dose, which enabled Provectus to be more effective in their approach to PV-10 dosing.
- He said he hoped the [monitoring] committee would stop the Phase 3 trial early on the basis of statistically superior numbers of the PV-10 arm compared to the comparator arm (of either DTIC or TMZ) and Rose Bengal's large safety dossier. -- [It make sense that management will very likely include an interim data read-out as part of the final protocol. Interim data generated from such a read-out presumably would be the basis for seeking early approval in Australia and terminating the Phase 3 trial in the U.S. for purposes of an early NDA filing.]
- The interviewer commented on the likelihood that the Phase 3 trial would be an open label one. Craig noted that PV-10's distinct color and intra-tumoral injection makes it very difficult to blind the study to either the treating physician or the patient. He also drove home the point that it is difficult to compare PV-10 either with historical standard of care drugs (like DTIC and TMZ) or recent approvals (like Yervoy and Zelboraf) on the basis of safety, efficacy, method of delivery, patient population, cost, among other things. -- [The former are provided intravenously or ingested and measure benefit in a very small number of months, while the latter are for very late stage patients (and is very expensive) or a genetic subset of the population (and patients relapse with the disease coming back with greater ferocity).]
Some other comments of Craig:
- A reminder Provectus is designing a Phase 1 pancreatic trial. --[Look for another creative and intelligent trial design by management. Typically Phase 1 trials test if a new treatment is safe (safety toxicity) and look for the best way to give the treatment (dosing). Management's version of a Phase 1 trial yield efficacy results (revealed for HCC, currently unrevealed for breast). A potential primary endpoint might be pain relief.]
- The European market for MM is increasing.
- While Craig did not want to provide specific comments about size of the accessible MM population for PV-10, he was very clear the eventual accessible patient population PV-10 was going to be much bigger than that of the label indication. In previous posts, I have noted management's strategy is to get approved quickly for a very focused indication. Of note was his comment that PV-10 could be used first by physicians contemplating surgery for their patients.
- Price of treatments is becoming more important. Craig mentioned the cost of treatment several times in the interview: the prohibitive or near-prohibitive cost of treatments on the market and the flexibility Provectus has with their pricing. -- [A stumbling block for much higher Yervoy sales is, among other things, the excessive cost of treatment. Provecust has not yet issued guidance on the price of PV-10. The presumed $20,000 to $30,000 cost is an assumption made by research analysts at Rodman & Renshaw and Maxim Group, and not based on any specific guidance from management.]
- At about 14:39, Craig provides a nice perspective on the mechanism of action: System wide anti-cancer immunity. Anti-tumor immunity. Self-destruct mechanism.
- He talked about the consistency, reproducibility and repeatability of results thus far, comparing Phase 1 trial patients with the first cohort of the Phase 2 trial and the suitable stage-based patients in the second cohort. The second cohort included much sicker patients who management felt needed to be in the trial because it was the right thing to do for them.
- Craig said it was important to watch patient acquisition. -- [The faster patients are enrolled and treated in both arms, the faster we can expect the time for the comparator arm to fail, and thus patients in that arm can be moved over to the PV-10 arm, as a precursor to waiting for the interim results to be made available.]