Replies to post #800 on Soligenix Inc (SNGX)

[io_io]

<<<<<"My bet is that DORB did a poor job in the preparation of their NDA">>>>

You mean this is the reason for the FDA extension ? I doubt that - their Briefing Documents were beautifully prepared, with no real errors, and the secondary analyses were treated second as they should. Also remember the FDA review is supposed to be done before ODAC, but instead their effort was laughable.


<<<<<"When you're talking about failing a primary endpoint these unexplained effects give one less confidence that there isn't type-1 error in the DORB analysis">>>>

Seeing as they didn't meet the primary endpoint, the 10-day guarantee period analysis would suggest that there is a danger of a type 2 error here - the danger of incorrectly accepting the null hypothesis of no benefit.

[io_io]

<"probably didn't have any answer for the differential (and inconsistent between trials) effect in myelos vs. non-myelos">



I don't think they expected the ODAC / FDA to go sub-group-mining, because that is a no-no. But anyway they submitted a Phase II trial, with all myelos, and you have much the same benefit.


By the way, I suspect that one analysis submitted late may have been for Steroid Failure in myelos v non-myelos in the Phase III. At ODAC, I think it was Tim Rodell said that in this analysis there was benefit to both sub-groups in that trial.

[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