Does Janet Woodcock have the stones?
Janet Woodcock, the new chief, has the power to look at secondary endpoints. CytoDyn gave them a huge statistically significant endpoint... the subgroup, which represents 80% of the clinical trial, was statistically relevant and met the primary endpoint with a p=.0319. In other words they crushed the endpoint.
t this point in the pandemic it will be interesting to see if the newly anointed FDA chief follows her own guidance... They are also recommending time to sustained recovery as a primary endpoint. CytoDyn also announced this weekend the discharged alive endpoint at Day 28. It showed leronlimab was 166% better than the placebo arm with a 28% probability of walking out of the hospital versus an 11% chance of walking out of the hospital.