CO, while essentially I agree with you, I put the odds of approval at over 90% only because of some of the other errant decisions I've seen from the FDA before. I've yet to be wrong about a product I felt was certain to be approved, but on more than one occasion the FDA asked for something more delaying approval by at least several months, and in a few cases years. Lives were lost in those occasions too, but that's how they operate.
The worst case, IMHO, was a drug aimed at a rare condition that was deadly in premature babies. The drug as produced didn't meet their shelf time requirements. They could have approved the drug, limiting it's shelf time and giving the company time to correct it, but they didn't. It wasn't approved, babies died, but well over a year later the shelf life problem was solved and the product approved. That was years ago, I think it may have been handled differently today, but my hesitancy to say 100% is because of witnessing decisions like that in the past. The other regulators may be a little better than the FDA.
A few years ago 60 Minutes ran a story on American Drs. who've set up practices in offshore hospital and recovery facilities that were truly 5 star in quality. They did so because there they could use products to treat their patients that were not available in the US and save the lives, or provide higher quality of life, to patients willing to go offshore for the treatment. Recovery was in nearby 5 star resorts until they could be released to go home. The costs generally were less than treatment here, but few if any insurance companies were paying at that time.
It will only be a few more months until we learn what the UK will do. I suspect the others will follow the UK lead on approval, but the company may not submit until the EDEN is qualified to make the commercial product. Share price post UK approval may have much to say about how quickly other trials can begin. No doubt the company will need money, dilution when we're trading say over $5 is far less impactful than doing so at just over $1. Much will depend on how the company is viewed by The Street once we gain that initial approval. I would hope that approval leads to LP and others representing the company making appearance in many brokerage and Institutional conferences, doing quarterly webcasts with questions from Analysts, etc. In short, they need to publicly fight to get NWBO's name out there, not hype, just an honest discussion of what they've done to date, and what the future could hold.
Recently the pictures taken at SNO I believe featured Tumor Agnostic on their display, could you imagine a picture of Dr. Liau and/or LP on the cover of Time magazine in front of a display suggesting that DCVax-L is tumor agnostic and the accompanying article supporting it. In time that's a possibility, and if things break right it may not take that much time. It all begins with UK approval.
Gary
