subsequently, the FDA appears willing to calculat
Post# of 148183
Quote:
subsequently, the FDA appears willing to calculate p values at 42 and 60 days if necessary to help us get an EUA
Were either the 42 or 60 day results part of GSK's trial design?
I'm still wondering whether we have the data at those points. Yes, we probably could figure out whether more patients died in those time frames, but would that simple fact be considered "data"?
I've always been in the camp that wished NP had gone along with the DSMC's recommendation to create a 3/4 point analysis w 42 day results. After all, they had SEEN THE DATA and CYDY had not. Unless their recommendation was more complex than we saw.