I saw the changes to the trial this morning and immediately thought that the FDA must be in love with the data from the emergency IND patients. The only way that increasing the size and duration of the trial makes any sense is if you’re pretty certain it’s not going to be a phase 2b/3, which would need to be as quick as possible, but instead a phase 4, which would need to be as thorough as possible.

Hearing NP say today that they were going to submit the 7-day data from the emergency patients and maybe ask for emergency approval definitely supported this theory. Maybe wishful thinking, maybe confirmation bias... but I’d like to think that for once the FDA could act appropriately for the urgency of the situation, and approve a drug with zero side effects that seems to demonstrate efficacy for a critical need.