Koo,

Perhaps I am hitching my NDA approval wagon to this FDA pronoucement, and to a lesser degree to Don's mention that he was going to be "very aggressive" with the regulators seeking NDAs.

Here's a quick cut and paste from my RVX DD file

DEC 2019:   FDA WANTS TO LOOSEN RULES FOR MEASURING SUCCESS OF TRIALS FOR SERIOUS CONDITIONS!!!  BETonMACE trial would have passed with flying colors under these proposed new rules!  (Did the FDA Issue this in response to the tragic near miss of the BETonMACE trial data??, perhaps... the timing and nature of loosened rules is interesting and the new rules seem written specifically for a trial like BETonMACE)

https://www.fda.gov/media/133660/download