The one that really bugs me is the severe/critical COVID study. Amarex royally botched the study design by failure to age stratify. Blame goes also to the NIH for failure to support the trial as remdesivir soaked up all the trial oxygen in the room. Why did the DSMB recommend expanding the trial to 6 weeks!!! This after two doses, last dose at day 7 and then no drug on board for sustained clinical impact, especially in the critical population that was on a death trajectory. DSMB had the power to alter the study based on results, working in the best interests of both patients and study sponsor…I think they failed to looked at interim data critically and missed the boat. Why did the FDA not come to the table with intellectual honesty and come to the reasonable conclusion supported by the data and say…yeah, sure looks like it’s working even if you did not hit your p-value, how about we give you an EUA and you put an explanation point on the results with a conditional phase 4 study. That whole chapter was a near miss for sure. Not all blame should be on Cytodyn…we’ve heard the audio presentation by Dr Jay to the NIH, and read the unearthed comments internal to FDA under Murray et al disparaging the company. My God, this hubris and mis-steps not only cost the company dearly but many patients died needlessly!

Fortunately Cytodyn is writing a new chapter under a new author and with the utmost editorial discretion…Scott Kelly let that chapter out of the bag with his comment:”I believe we will become known as an oncology company.”