- A consensus agreement on a design suitable for Special Protocol Assessment (SPA) for the company’s planned pivotal Phase 3 randomized controlled trial (RCT) of PV-10 for metastatic melanoma; and,
- Top-line data from Provectus' Phase 2C clinical trial of PH-10 for the treatment of psoriasis.
How often have you seen an illustration of the risk-reward curve, as it relates to investing, where as risk in a given transaction increases so does the reward (or was it, as reward in a given transaction increases so does the risk)? Trading risk for reward, or reward for risk. Hmmm...
The psoriasis equivalent is trading safety (risk) for efficacy (return).
What I'll be looking for in these top-line psoriasis numbers is efficacy. Are they poor, average, good or great? If efficacy is average to good -- middle of the pack, so to speak -- then given PH-10's safety profile: winner, winner, chicken dinner.
It quite conceivable that Provectus' Phase 2C trial design had limitations that in the not so distant future might reasonable be removed or reduced. Might PH-10 be:
- Applied longer than 28 days (like, for example, 2-3 months)?
- Applied at different times during the day?
- And so on...
"...in all undertakings in which there are risks of great losses, there must also be hopes of great gains." (Alfred Marshall)
I think the smart folks on Wall Street, and many, many others, conveniently dropped (or, more likely, forgot) the word "hopes."
The psoriasis equivalent is, while enjoying the same safety (risk), what will the next trial design do for efficacy (return)? If efficacy of the Phase 2C is average to good, then lifting some of the old trial's limitations in the new trial could well increase efficacy to great. Onwards and upwards...