I agree with those who think the FDA letter is an advance CYA. Your comment and Ohm's about EIND not being pulled is one point. The 8K, Brazil and PI progress are three others. Mounting outcry from MDs on the ground, politicians, and the public squeezing them hard. It seems natural that if you are going to be really embarrassed or in trouble over poor decisions (i.e. a BP inspired slow walk of a perfect drug in a pandemic), you have to put out an advance reason (excuse) for your incompetence, negligence, and / or criminal intent. That's my bet....