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Sunday, July 31, 2022 5:55:24 PM
No, one can look at the trial on its face and realize that the crossover mechanism creates the possibility for recurrent glioblastoma results on a phase 3 trial. This is an adaptive trial. The FDA ctually encourages adaptive trials and is not trying to be wasteful just for the effect of being wasteful. They have been collecting this data for years.
One can posit, before unblinding, that there could be good results for recurrent patients as well, which is quite obvious from the facts. In addition, they have had numerous patients in compassionate use contexts who were recurrent who have had incredible results, many of whom have gone quite public with their own websites, telling their own stories. So of course, without unblinding, it would occur to them that perhaps they would have good data. They did not unblind and then realize that was a possibility, they had the data the whole time, and it became quite obvious.
You must think all scientists and regulators are quite serious simpletons. It's an incredible perspective, but unfortunately again, seems unlikely to be plausible. But, I guess plausibly you can argue they are all simpletons. But you can't argue that they were "data dredging" which by its meaning, in fact, suggests that they were unblinded before they updated their SAP, which is absolutely, factually incorrect. It was the subject of a lawsuit, it has been proven time and time again to be false, and one could argue that continuing to argue it, depending on the source and the persons, might be quite reckless and possibly malicious. So I would contemplate that reality.
One can posit, before unblinding, that there could be good results for recurrent patients as well, which is quite obvious from the facts. In addition, they have had numerous patients in compassionate use contexts who were recurrent who have had incredible results, many of whom have gone quite public with their own websites, telling their own stories. So of course, without unblinding, it would occur to them that perhaps they would have good data. They did not unblind and then realize that was a possibility, they had the data the whole time, and it became quite obvious.
You must think all scientists and regulators are quite serious simpletons. It's an incredible perspective, but unfortunately again, seems unlikely to be plausible. But, I guess plausibly you can argue they are all simpletons. But you can't argue that they were "data dredging" which by its meaning, in fact, suggests that they were unblinded before they updated their SAP, which is absolutely, factually incorrect. It was the subject of a lawsuit, it has been proven time and time again to be false, and one could argue that continuing to argue it, depending on the source and the persons, might be quite reckless and possibly malicious. So I would contemplate that reality.
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