I don’t know, I can see that the fda is just flat out stuck on statistical significance in CD12 and it will not do the job. I don’t understand why we have an extension of CD12 if it could not lead to some approval. The confusing part is how can an extension of the trial work? Is it allowing more than 2 doses? Is there a placebo arm of the extension? I just don’t get how this can fix CD12 as a trial. If the FDA just wants a clean trial with a p value, the extension won’t do that.

Also, why did we have the protocols ready to go for new trials weeks ago with no FDA response? They did alter the protocol but in the past these protocols are approved relatively quickly. Now we are looking at doing the trials in Brazil and India? Could be that is because they will recruited fast? Could be we are throwing in the towel on the FDA and pursuing the world instead? Why have the world wait for the FDA?

I can say, it is obvious we are looking to have data and real world results as quickly as possible. The media will hopefully fully see what is going on and the FDA is going to have to deal with it. What is really frustrating I I can’t see what the FDA has done to change how they do things in response to the pandemic. The total lack of any creative action to speed up the process is just Kafkaesqe.