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jour_trader

06/28/18 8:58 PM

#292651 RE: WeeZuhl #292649

Has the interim analysis been published? Here was the initial plan for the PIII Isradipine study for PD:

"Interim analyses

An interim analysis for futility and efficacy will be performed after primary outcome data are available for the first 168 participants (50%) to enroll. The study will be terminated for futility if the interim analysis shows that the conditional power of rejecting the null hypothesis in favor of a beneficial effect of isradipine is lower than 20% under any scenario that is consistent with the data accrued at that time. A two-sided P-value in favor of isradipine of less than 0.001 will be required to stop for efficacy at the interim analysis. The stringent alpha level for efficacy was chosen so as to have minimal effect on the final P-value, should the study run to completion. In addressing futility, the DSMB will examine a range of possible treatment effects consistent with the data obtained in the study at the time of analysis."

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5454402/
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jour_trader

06/28/18 8:58 PM

#292652 RE: WeeZuhl #292649

Has the interim analysis been published? Here was the initial plan for the PIII Isradipine study for PD:

"Interim analyses

An interim analysis for futility and efficacy will be performed after primary outcome data are available for the first 168 participants (50%) to enroll. The study will be terminated for futility if the interim analysis shows that the conditional power of rejecting the null hypothesis in favor of a beneficial effect of isradipine is lower than 20% under any scenario that is consistent with the data accrued at that time. A two-sided P-value in favor of isradipine of less than 0.001 will be required to stop for efficacy at the interim analysis. The stringent alpha level for efficacy was chosen so as to have minimal effect on the final P-value, should the study run to completion. In addressing futility, the DSMB will examine a range of possible treatment effects consistent with the data obtained in the study at the time of analysis."

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5454402/
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SCHH

06/29/18 7:30 AM

#292669 RE: WeeZuhl #292649

my two cents...
somehow, way back in history,,,FDA put ELTP in the sh.t box because of the over the top selling of Naz...

somehow down deep the FDA holdovers that are still there are wanting for NAZ to totally fail and are reserving approvals until after the company is sold (?) or ....NAZ is gone

Then I think the acceptance flood open and ELTP (OR WHATEVER THE NAME or STRUCTURE will be... they will fly !!!!!!!!!!!!!!!!

can we wait much longer.???..former investments have been decimated and even a 100% comeback will put us about 16-20 cents. yuk ...

six years and still holding on...like the titanic captain with the violins playing in the background.