“At least we know what mgmt’s plan is… finish Brazil, pursue BTD in cancer, finish BLA.”
CYDY will not receive BTD for a hodge podge of data from trial (10) and non-trial (20) patients who are likely on a number of different drugs besides leronlimab.
Additionally, the FDA will not like the claims in yesterday’s PR.
What is a “final report”?
What does, “as much as 980% increase” in 12 month overall survival mean? That only one patient met that % and the others were less?
What does, “as much as 660%” in 12 month modified progression free survival? That only one patient experienced this %?
The SEC and the FDA are going to have some questions about that PR and will want to see the data (p value?) to support the claims.