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Wednesday, July 14, 2021 11:19:51 AM
No, the redefinition is not driven by NWBO, and happened before unblinding anyway. So that would certainly be consistent with the AF’s allegations but it is factually incorrect. Factually incorrect allegations, even if made just to make noise, are still incorrect and will have no impact on the FDA’s decision making.
Basically the FDA would not take note of such noise. It’s not relevant to the historical record, the science or the facts. NWBO does not drive the WHO’s or the oncology community’s definitions of specific cancers and in fact, getting the data prior to data lock was likely hugely difficult, costly and inconvenient for the company, so that it could follow the scientific community’s updated view. As to NWBO, that view could have gone any way. It just happens to be favorable to the company. They did not make it so, the science made it so.
Basically the FDA would not take note of such noise. It’s not relevant to the historical record, the science or the facts. NWBO does not drive the WHO’s or the oncology community’s definitions of specific cancers and in fact, getting the data prior to data lock was likely hugely difficult, costly and inconvenient for the company, so that it could follow the scientific community’s updated view. As to NWBO, that view could have gone any way. It just happens to be favorable to the company. They did not make it so, the science made it so.
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