Biotech Values

[exwannabe]

Where did 7% come from in NFLD NI trial.

The PR for NFLD said that the NI trial goal was to be within 7% of the blood arm. I assume this means that you take the placebo arm's OS point value + 7% and compare to the 95% CI of the PolyHeme arm.

So where did this 7% figure come from? You really don't have anything like large trial data on blood vs. saline or whatever, do you? Does the company just sit in a room with some FDA guys and use various studies to pick numbers out of? The variables in trauma situations are so extreme it's seams impossible to have a real NI margin.

Is the whole concept of a formal NI trial based on providing some fraction of the comparator's effect just BS here, and they (includling the FDA) are just making things up as they go?