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loanranger

01/04/19 6:05 PM

#253446 RE: georgejjl #253443

I guess that could be one explanation but it wasn't my point.

I guess I need to explain. Per an October 2016 PR:
“We look forward to efficient execution of this important trial for our psoriasis program. Having partnered with one of the premier CROs in the Dermatology therapy area for this study, I am confident that we will be able to assess interim and final study results in a timely fashion,” said Jane Harness, Cellceutix VP, Clinical Sciences and Portfolio Management.

No interim Prurisol assessment, timely or otherwise, was made....or at least none was announced as far as I know. The point of my post was to raise the question as to whether an interim assessment, as was done by Protagonist, might have saved IPIX shareholders some money and/or dilutive issuances expended on the Prurisol trial. I guess we'll never know that. Will they re-test the 200 mg trial or will we never know that either? The Company said it was successful in the mild-to-moderate population. It was one of those trials that never failed.
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georgejjl

01/04/19 7:00 PM

#253450 RE: georgejjl #253443

The same thing could have happened in the Prurisol Phase 2b trial

The CRO could have mixed up which subjects got the two active Prurisol doses and the subjects taking just a placebo.



The interim data revealed an unusually high placebo rate of clinical remission (24 percent, approximately four times higher than historical norms for similar UC studies) that led to a futility decision and discontinuation of the trial."


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.



Good luck and GOD bless,

George