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Saturday, April 21, 2018 8:27:18 PM
We can agree that interim report is not produced at a whim, especially in trials destined for marketing application support. That means: if there ever was a planned interim report for prurisol phase 2b then it must have been specified in the trial protocol (which we don't have) and specified to be performed by CRO at pre-specified number of pre-specified events.
My guess is for interim prurisol report the pre-specified events were the count of subjects that had completed the trial. In order to make many statistical sense in terms of statistical power the count should have been above 60 % of enrolled subjects.
It turns out that p2b schedule was slipping from the get go; first the interim results was due Q2 2017 then Q3 2017. After that it vanished. The filings at ClinicalTrials.gov indicate that the trial may have become significantly back loaded - until June 2017 IPXI/CRO still believed that they can complete the trial during Q32017. In July they knew the could not. Also, between May 2017 and June 2017 they added 4 new trial sites, each in large population center (2 in LA, 1 in Vegas and 1 in Savannah) - enrollment rate should have picked up a lot after May 2017.
The evidence suggest that if there ever was a planned interim report specfied time for it may have eventually been so close to the end of trial that the report became superfluous. That is, if there ever was a planned interim report; IPIX never published subject/event requirement for it. Why?
See this for evidence .
Recent IPIX News
- Form 8-K - Current report • Edgar (US Regulatory) • 02/01/2024 01:30:25 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/05/2023 09:25:58 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/20/2023 09:05:44 PM
- Form NT 10-Q - Notification of inability to timely file Form 10-Q or 10-QSB • Edgar (US Regulatory) • 11/15/2023 01:00:19 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/30/2023 08:15:25 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 09/28/2023 01:00:08 PM
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