[John Henry to Billy Beane, from the movie Moneyball, which is based on the book Moneyball: The Art of Winning an Unfair Game by Michael Lewis ] "I know you are taking it in the teeth, but the first guy through the wall... he always gets bloody... always. This is threatening not just a way of doing business... but in their minds, it's threatening the game. Really what it's threatening is their livelihood, their jobs. It's threatening the way they do things... and every time that happens, whether it's the government, a way of doing business, whatever, the people who are holding the reins - they have their hands on the switch - they go batshit crazy."
It is clear to me I did not sufficiently appreciate industry skepticism, whether from regulatory agencies, pharmaceutical companies, clinicians, researchers, journalists or investors, about a local agent providing a systemic benefit (let alone a robust immune one). There is a quite lot, however, I did and do appreciate about Provectus.
Today, I had the opportunity to speak one-on-one with Moffitt Cancer Center's Dr. Jeffrey Weber, courtesy of Eric and Peter. He is director of Moffitt's Donald A. Adam Comprehensive Melanoma Research Center of Excellence ("MRCoE"), and "works closely with James J. Mulé, PhD, associate center director of Translational Science and melanoma expert, and Vernon K. Sondak, MD, chair of the Cutaneous Oncology Department, to develop multidisciplinary research focused on melanoma." Dr. Weber and the MRCoE are investigating and developing treatments that direct the immune system to attack melanoma cells, and treatments and strategies to block pathways important for melanoma development, growth and spread. I appreciated him giving me the time to willingly answer my questions. I do not have Dr. Weber's permission to share the details of our conversation (n.b. I did not seek it), I must refrain from writing about it on the blog.
As I previously wrote, I remain convinced management is seeking accelerated or outright approval of PV-10 as a monotherapy for patients with Stage IIIb-IIIc melanoma who are refractory to multiple prior treatments, because I believe they think they've shown enough information to the FDA to fully support this ask, which I believe has been made. I also think they are seeking breakthrough therapy designation for the use of PV-10 in combination with certain other agents for patients with Stage IV melanoma, fully understanding that, while pre-clinical and clinical work could make a case of a role(s) for PV-10 for these heavily disease burdened patients, more data is required to better optimize its use.
As to what the FDA will agree, that ultimately is the crux of the company's current situation.
Only when regulatory clarity is achieved [it now seems to me] should license deals be consummated, whether regional, worldwide or both. Their magnitude and swiftness of closure should depend on the time value [to approval] of the clarity received.
There may be a fine line between using history and historical experience as a guide and lessons to learn from for investing successfully, and sufficiently forgetting the/a past so as not to anchor or wrongly influence future decisions. Then again, maybe the line isn't so fine, and learning whether it is or isn't (and in what context or situation) ultimately makes me a better investor.
Management has positioned the company with the FDA for this moment. What say you FDA?
Data talks, nobody walks.