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Thursday, January 17, 2019 7:54:29 AM
From a Mar PR
..., today announced that final study-related visits have commenced for patients enrolled in its REDUCE-IT cardiovascular outcomes study. An important step in completion of this potentially landmark study is to have patients return to their clinical sites for final study data collection. Commencing final patient visits on March 1, 2018 is consistent with the company's estimated schedule of having results of this first of its kind study announced before the end of the third quarter of this year.
So they announced the trial had reached the pre-designated event threashold. As patient visits were twice a year, it would take 6 months to collect the data. All to timelime, all well explained. Just like the 2 IAs were both announced and the results (continue rec.) were announced. The exact opposite of anything LP does.
AMRN also stated back then:
Amarin is intentionally blinded to the results of the study and will remain blinded to such results until after the study is completed and the database is locked. Final patient visits will be followed by adjudication of newly reported cardiovascular events in the study, completing data entry for the greater than 33,000 patient years of study in REDUCE-IT, and typical database quality control measures, known as cleaning.
As is the normal case, they were unblinded as soon as the lock for the primary endpoint is done. NWBO asserts they will remain blinded while they contract a third party to perform a multi month stat analysis. Why? Who knows, but it always reads like LP is not eager to have results.
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