Unless you're somewhere on the inside, you cannot be certain when the next announcement from the company will come, or what it will say. It could say our SAP has now been accepted by all 4 regulators, but it doesn't have to. It could say the trial is now unblinded, but it doesn't have to. Finally it could say, here are the top line results, that's the one thing that eventually has to be said, it may not be the first thing to be said, but you don't have top line results until they're announced.
I still hope TLD will come this year, just because it would be nice if it did so, but I cannot say it will. I certainly expect it before the end of the first quarter of next year based on what we've heard from DI, but it wouldn't be the end of the world if that didn't happen. I know it's frustrating, especially for those who invested many years, or even a decade or more ago, but it still has the potential of being the biggest investment gain of your lifetime, at least on a percentage basis if you've averaged down to somewhere around a dollar or less.
I would like to see a BLA filed by the third quarter of next year, or before, but if it isn't filed before the end of the year, I can live with it, as long as we have reassurances that it will be filed. I still believe that before it's filed a partnership will be established, but again, not the end of the world if it isn't.
The key IMHO is all the people who're still alive, as long as that is true, I have faith that the vaccine will eventually be approved, even if it's not on first FDA approach, it will be approved. No one likes delays, but given the FDA history, I don't care how great the data looks, and I believe the numbers alive make it great, the FDA can cause delays, and possibly additional trials. I believe approval by the other regulators will be easier than the FDA, but it's very possible that all will come in without delay. To me, overall survival is the gold standard for approval, few trials go for it as it takes much longer, but I believe our results are solid because so many patients in the trial are still alive, and that many who passed on did so after 3, 4, 5 years or longer in a disease that typically kills 95% in 5 years.
I certainly don't know, but I believe that much has been learned in the trial that would increase longevity if it were initiated today. It's speculation that the last group to enter the trial have greater percentages alive than those at the same point in the earlier trial. If true, future patients may have a 50% shot at living 5 years or longer, ten times that of the SOC today. As I understand it, 31 patients were initiated after the hold, now more than 4 years ago, if more than 16 of them are still alive, the odds are pretty good that half of them will reach 5 years, the K-M curve should tell that tale.
Gary
AI
