I think we all need to learn more about failure. In our Phase 3 Trial we had a number of events that people called failure, they were patients determined to have progressed. I really don't know if some of those failures are still alive, but they could be. If they're not alive, they very probably lived many months or years longer than they thought they would, but they progressed, so they were failures. If they are still alive, they can tell us how bad they feel for having failed, if they're no longer with us we could ask their family and friends if they enjoyed the extra time they had with them. These failures actually had pseudoprogression, but many here would still argue the trial was still a failure because PFS was called on these patients, and not for many who didn't get the vaccine until later, so clearly the PFS goal failed.
I believe that every drugmaker would be thrilled to fail with so much success. People are living longer, but the trial failed, that's what the bashers are telling us, but of course they don't mention the patients living longer, only that PFS was called on many patients who got the vaccine and that's all that matters in their mind. Patients live longer, many are still alive now after ten or more years, but trials a failure because many of the people still alive were judged to progress, so they failed in the PFS goal.
All the people telling us this are also telling us that the four regulators who worked with the company will not approve the vaccine because of the failure in PFS, after all, what matters, a goal that's flawed because of what was learned in the trial, or a lot of people living well beyond what's seen by patients on the SOC. Finally, lets not consider what happens when other therapeutics are added and patients live roughly four times as much as with the vaccine in the trial protocol alone.
I believe it would be criminal if any of the regulators don't approve the vaccine once the company applies for it.
Gary
