Soligenix Inc (SNGX)

[drbio45]

the 10 day garantee period was not a secondary endpoint so I don't think that is part of any fda analysis.

they didn't have the 10 garantte period as a secondary endpoint because they never expected the failures in the first 10 days. they had a better outcome in the first 10 days in the phase 2 trial.

the only part i think they did a poor job in was that they didn't include the secondary endpoint of treatment failures at 50 days. there were 30 treatment failure on placebo and 18 treatment failures on orbec with a p value of .0515 at day 50.
I think if they had brought that out to the panel members they wouldn't have thought the trial failed. the primary endpoint in the trial was a weighted average of treatment failure though day 50 which had a p value of .11. i think the panel members didn't realize the difference.

the secondary endpoint of .0515 was in the dor briefing docs but i don't think the panel ever even looked at them