I'm not certain if a placeholder Abstract was submitted, it may have been, but I also was led to believe the people running the SNO Conference can select up to 5 late breaking presentations. I cannot say if we were selected by them, or if we made a submission interesting enough to them to be put in this prestigious position. I believe they've known enough about what's happening in the trial to know it's not a failure. For example, as lead clinician I believe Dr. Liau would know how many are remaining alive. Sure, no one knows with absolute certainty that all alive are on the vaccine, but with the crossover design, at most a couple may not be.
In short, if Dr. Liau knows 40+ are living, she knows it's at least 3 times what would have been expected with the SOC. If that doesn't spell success, I don't know what would. I'm still of the belief that it's 60 or more remaining alive, I'd classify that as a spectacular success.
At the conference they'll be able to present a number of K-M plots for various ways the patients can be divided up that may suggest certain patients get a greater benefit. The question might be, if the worst patient group sees a small benefit, should the approval include that group. My belief is that if there is any benefit at all, the patients should be included, otherwise it will be a case where the wealthiest will get it off label regardless, while the poor will not.
The only real question in my mind about approvals if I'm correct about the numbers surviving is whether any of the regulators will expedite approval, essentially like doing a EUA rather than waiting to judge a BLA. I believe it's possible elsewhere, but doubt it here in the U.S.
Gary
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