Thursday, October 29, 2020

Global – 44,000,000/1,200,000; USA – 8,800,000/227,000 POTUS in complete denial that there is a raging pandemic and everything is spiking. He keeps insisting that we have “turned the corner” or “rounding the turn”. Some potentially nefarious stuff going on. The FDA career scientists are hesitant to grant EUAs to Lilly’s and Regeneron’s mAb based on the current data. Alex Azar is really pushing them and furious because he thinks FDA is “slowwalking” the process so as not to have it out before the election in 5 days. Clearly, Alex wants to please the POTUS so that they can say that they have a breakthrough (similar to Convalescent plasma nonsense) right before the election. Azar then asked NIH (Collins), CDC (Redfield) and ASPR (Kadlec) to weigh in since the legislation that established the EUA process (dating back to the Anthrax situation in 2001) requires the CDC, NIH, and ASPR Directors to weigh in on EUA decisions (even though they have not done so in the past). Cliff and I had long conversation with Francis on his way down to HHS to discuss with Azar. We encouraged Francis to support the career scientists at FDA since they do not want to rush this through. They need more time to gather important information since what they have now is rather weak.