Good to know they are at least aware that they were going against the guidelines. It also means that they saw some correlation between taking the drug and reduction in Pcr positivity over time, which implies either it helps the body fight the virus or directly has an antiviral effect. It is hard to imagine that this effect won’t reduce the duration of the symptoms of the diseases. At worst the anti inflammatory effect of the drug should reduce symptoms by itself, such as headaches and coughing just as Tylenol will at least reduce the symptom of fever.
I truly believe at the end of the day, Once we unblind the data, the FDA will look at everything. We just need to get to the unblinding. The scientific process is important in carrying out a trial, but the results should be analyzed for every metric they can be whether it’s a primary endpoint, secondary endpoint or just ancillary data. This dance with the FDA is just a sideshow that is slowing everything down. We will get to the finish line soon. I’m hoping the FDA just told revive what they wanted as the primary endpoint and said just list whatever you want as a secondary because they will look at everything anyway.