This was in the middle of the vaccine trials for COVID-19 vaccines. The vaccine trials were Emergency Use basis. One of the facts pointed to in this presentation is that deaths from Alzheimer's Disease increased 150 percent from 2000-2018. That has to play on the minds of this panel in an atmosphere of urgency regarding the COVID-19 vaccine.
Friday, November 6, 2020
Page 23 of 325 pages
...Before briefly describing some of the issues (click here) we will ask you to discuss today, I want to stress that we have not made any final decisions on the approvability of this application. With that said, you have had the opportunity to review background materials, including the briefing documents and presentations from the applicant and FDA prior to today's meeting. Today, following my remarks, you will first hear a summary presentation from the applicant reviewing important aspects of the data presented in support of aducanumab's approval. After that, I will return to discuss the issues involved in consideration of these data. The reason we are here today is to gain your input into some of the issues we have confronted during our review process. Thank you for the substantial efforts you have made in preparing for and attending this meeting, and thank you for the important work you will do today....
