Wait, what Mayo said was that the Omitted Data CAN be included in appeal. Let’s be clear and not confuse people. ///
“ Data that came out after the application (ABCLEAR 2, ABCLEAR 3, Brain atrophy TIED to ABCLEAR2/3, ADNI comparisons, prodromal comparisons, etc.) were ALL excluded from the actual regulatory decision. The company is almost certainly going to appeal as soon as possible (in Dec) to try again with approval. The difference is that with appeal, they CAN use all the aforementioned data which insurmountably improves the strength of the filing…”