As far as I can tell, the delay is 100% on the FDA

As far as I can tell, the delay is 100% on the FDA. Remember, the FDA wanted 70% efficacy - leronlimab did that with 325 dose. We should have been able to get BLA filed and done over a year ago. This continuing need by the FDA to see more is crazy. A majority of approved drugs are no this safe and not this effective - imagine if during a trial there was some side effect or failure, that is what most biotechs have to deal with. I think the FDA is shocked but this drug and is trying to find it's failing because that would bring these trial results back to earth. The FDA is asking for too much and wasting time and money. I don't think Nader is getting some detailed feedback from the FDA, ignoring most of it and giving PRs of timelines based on nothing. Cytoyn is doing what ever the FDA wants, when they want it.