Thanks Doc,
I like your reasoning, but do have one question, will the trial for Direct that's upcoming be open to evaluation from the beginning. If not, while there could be peeks at it where the clinicians could advise the company, wouldn't we need to reach the end to truly have data on the trial. I'd love to see it as an open trial where all could see how it's doing, perhaps in a broad variation of cancers, but I wonder if the FDA and other authorities will agree to such a trial.
As I see it, if results are revealed for L in the next few months, it's possible for a BLA to be filed this year, but more likely it will be filed early next year. With the FDA taking their permitted 6 months to evaluate the BLA, approval in the last half of 2020 is possible. The question might be, could the trial of Direct if blinded be so short as to be unblinded by that point, or at least to the point where the first peek was permitted. If that's the case, investors would be encouraged to hold on regardless of the ups and downs we may see in approaching the approval decision. On the other hand, many could trade on these up and downs, and if they're good add significant shares in doing so. Personally I've never liked being out of a company I believe could have good news at any time. Even the FDA can't be relied on to take 6 months, they're striving to decide in 5, but who knows, they could say yes even quicker on the sort of data I believe we'll be providing for L. To me there is nothing more positive than people surviving dramatically longer than anticipated, and I believe that will be the case with L.
Once the trial's unblinded we may learn that some percentage of the survivors are believed to be cancer free, whether you can say cured or not, that's a rare achievement. I'm sort of in the same situation with leukemia, they can find no indication, but I remain on chemo as they know that roughly 30% of patients come out of remission if they don't continue it, far less if you do. If they could find a way to determine the 70% who wouldn't come out, you'd have a 70% cure, but to date they cannot.
I recently had a skin cancer removed, if I count that one, I've been treated for four totally unrelated cancers. I suspect that many of us, if we live to old age, will have similar stories. Frankly whoever originally named such growths cancer did us a disservice as politicians, etc. speak of curing cancer, like it's a single disease. Clearly it's not, and the deeper we dig into it, the more complex we find it to be. The article on the 4 major types of GBM that have been identified adds to its complexity. While our vaccine may help in fighting all four, we really don't know, it doesn't do it alone, and we may find over time that different approaches are needed for each type, but it's still possible that L, or Direct, or both may be a part of the treatment regardless because it's personalized in the first place.
I would suspect that if anyone could ever know, in the course of a lifetime we all defeat many forms of cancer without ever knowing it. At some point a determination might be made to create Direct, or something similar to it, on what seems to be a healthy patient, because by routinely administering it, a variety of cancers could be defeated before they ever reach the point where they're diagnosed. I'm not suggesting that once in your lifetime such treatment could be used, but what if it were once every 5 or 10 years, rather like a colon scan, wouldn't it make sense. It won't happen in my lifetime, but that just might be how many forms of cancer are eliminated in the future.
Gary
