A good question. I think it depends what we mean by MOA. The FDA will certainly want to know the primary Mode Of Action - but I think that part is indeed well understood. Viral infection and replication, leading to cell destruction, has been studied extensively for a long time.
The aspect that Yuman says they "don't have all the answers for" is the almost total preference of CF33 to infect cancer cells exclusively, leaving normal tissue unharmed. Yuman talks about that in response to a question at about 47:10 in the vid. It's a great question and Yuman has a couple of theories, but he admits that they don't really know.
I think it is an important piece of the puzzle from a pure science perspective, but I would suggest that it is no longer vital from the FDA's perspective. It was probably part of the FDA's initial caution. You may recall that the trial protocol required them to start off with incredibly small dosages, and a staggered start with a long gap between commencements for each new patient. Yuman referred to it as "teeny tiny doses" when he came out here for the investor roadshows early last year.
That caution was all about initial safety concerns, and one of those concerns would have been "what if we get a runaway infection in healthy tissue?"
However CF33 has by this point demonstrated excellent - indeed remarkable - safety and tolerability, with no infection of healthy tissue. So I don't think that's something the FDA will be concerned about now. If they were concerned, they would not have granted Fast Track designation and they would be further restricting the trials.
Really, I think it is a great validation of Yuman's approach to the problem, which he summarises very neatly and modestly in the vid from 48:30 - 49:20 Instead of trying to actively "design" the virus, they just used natural selection and evolution. I think "just" is an understatement though - because there was some very very intelligent science involved in speeding up the process and in choosing the right initial source viruses.
Like many great breakthroughs the concept is actually quite simple and elegant - when viewed in retrospect - but it took a very wise intuitive leap to find that solution, and then some serious technical expertise to make it work.
Professor Yuman Fong is actually a rather remarkable individual. He has a rare combination of intellect and intuition, combined with genuine humanity and modesty. A great communicator, a humanitarian, and with a wider interest in arts and music... Some years ago LC described him as a "Renaissance man" - and that is pretty accurate. He is one of the few people I have met in person whom I would describe as instantly likeable. Not in the slick surface way of an accomplished political or PR person. My iimpression was that Yuman is totally genuine and sincere.
It is of course entirely possible to be both brilliant and mistaken. For sure Yuman - like all scientists - will have headed down some dead ends and developed some incorrect hypotheses. That's how science works!! However.... all the basic science behind CF33 seems to be playing out as expected, and Yuman's confidence levels seem higher than ever.
He doesn't strike me as someone who would be prone to self deception and delusion.
I follow the science to the extent that I am able to do that - because I find it incredibly interesting and I love learning new things - but beyond my very definitely limited knowledge all I can do is listen to the experts. Yuman, of course, but also the reactions of the FDA, and the fact that Yuman presents his work in peer reviewed publications and at major peer reviewed medical science conferences.
Ultimately, the clinical trial results will be the proof, and we all have to wait for that - Yuman included.
Cheers
Dave
IMU Price at posting:
4.8¢ Sentiment: Buy Disclosure: Held
(20min delay)