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PlentyParanoid

01/05/19 9:41 AM

#253474 RE: loanranger #253461

LR, you are asking a question for which there is currently no good answer. We need to know the results (numbers) from p2b before we can address what would had happened with interim analysis. And even then it would be statistical inference, not certainty. Remember also that those delays in running the trial might have prevented or perverted the interim analysis. We probably will never know with reasonable certainty.

georgejjl

01/05/19 9:43 AM

#253476 RE: loanranger #253461

My first guess was right on target.

So your first guess at the issue apparently wasn't right:
("If the placebo clinical remission rate was 4 times normal, then that begs the question if some of the subjects that were thought to be on placebo were actual on the active trial treatment.")



If the placebo response rate exceeds the historic norm by a significant amount in that case 4 times the norm, then there most probably has been an error in the trial attributable to the CRO.-

The Prurisol Phase 2b trial could prove to have been highly and statistically significant and successful when the complete data has been analyzed.

GOD bless,

George